兒童注射疼痛

Psychological interventions for needle-related procedural pain
and distress in children and adolescents (Review)

Uman LS, Birnie KA, Noel M, Parker JA, Chambers CT, McGrath PJ, Kisely SR
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane
Collaboration and published in The Cochrane Library
2013, Issue 10
http://www.thecochranelibrary.com
Psychological interventions for needle-related procedural pain and distress in c
hildren and adolescents (Review)
Copyright c 2013 The Cochrane Collaboration. Published by JohnWiley & Sons, Ltd.
T A B L E O F C O N T E N T S
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 1
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. 2
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. 2
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 4
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 4
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . 10
Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 13
Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 14
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 17
AUTHORS' CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
21
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 22
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 33
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . 103
Analysis 1.1. Comparison 1 Distraction, Outcome 1 Self-reported pain. . . . . .
. . . . . . . . . . . 105
Analysis 1.2. Comparison 1 Distraction, Outcome 2 Observer-reported pain. . . .
. . . . . . . . . . . 106
Analysis 1.3. Comparison 1 Distraction, Outcome 3 Self-reported distress. . . .
. . . . . . . . . . . . 107
Analysis 1.4. Comparison 1 Distraction, Outcome 4 Observer-reported distress. .
. . . . . . . . . . . . 107
Analysis 1.5. Comparison 1 Distraction, Outcome 5 Behavioral measures- Pain. . .
. . . . . . . . . . . 108
Analysis 1.6. Comparison 1 Distraction, Outcome 6 Behavioral measures- Distress.
. . . . . . . . . . . . 109
Analysis 1.7. Comparison 1 Distraction, Outcome 7 Physiological measure - Heart
Rate. . . . . . . . . . . 110
Analysis 1.8. Comparison 1 Distraction, Outcome 8 Physiological measure - Oxygen
Saturation. . . . . . . . 110
Analysis 2.1. Comparison 2 Hypnosis, Outcome 1 Self-reported pain. . . . . . . .
. . . . . . . . . 111
Analysis 2.2. Comparison 2 Hypnosis, Outcome 2 Self-reported distress. . . . . .
. . . . . . . . . . 112
Analysis 2.3. Comparison 2 Hypnosis, Outcome 3 Behavioral measures- Distress. .
. . . . . . . . . . . 113
Analysis 3.1. Comparison 3 Preparation and information, Outcome 1 Self-reported
pain. . . . . . . . . . . 114
Analysis 4.1. Comparison 4 Virtual reality, Outcome 1 Self-reported pain. . . .
. . . . . . . . . . . . 114
Analysis 5.1. Comparison 5 CBT-combined, Outcome 1 Self-reported pain. . . . . .
. . . . . . . . . 115
Analysis 5.2. Comparison 5 CBT-combined, Outcome 2 Self-reported distress. . . .
. . . . . . . . . . 116
Analysis 5.3. Comparison 5 CBT-combined, Outcome 3 Observer-reported distress. .
. . . . . . . . . . 116
Analysis 5.4. Comparison 5 CBT-combined, Outcome 4 Behavioral measures- Distress
. . . . . . . . . . . 117
Analysis 6.1. Comparison 6 Parent coaching + child distraction, Outcome 1 Self-r
eported pain. . . . . . . . . 118
Analysis 6.2. Comparison 6 Parent coaching + child distraction, Outcome 2 Observ
er-reported distress. . . . . . 118
Analysis 6.3. Comparison 6 Parent coaching + child distraction, Outcome 3 Behavi
oral measures- Distress. . . . . 119
Analysis 7.1. Comparison 7 Suggestion, Outcome 1 Self-reported pain. . . . . . .
. . . . . . . . . . 120
ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . 120
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 124
WHAT'S NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. 133
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . 133
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. 134
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 134
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 134
DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . .
. 135
NOTES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . 135
INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 135
hildren and adolescents (Review) i
[Intervention Review]
Psychological interventions for needle-related procedural pain
and distress in children and adolescents
Lindsay S Uman1, Kathryn A Birnie2, Melanie Noel2, Jennifer A Parker2, Christine
T Chambers3, Patrick J McGrath3, Steve R Kisely
4
1IWK Health Centre & Dalhousie University, Halifax, Canada. 2Centre for Pediatri
c Pain Research, IWK Health Centre, Halifax,
Canada. 3Department of Psychology, Dalhousie University, Department of Pediatric
s (GI Division), IWK Health Centre, Halifax,
Canada. 4School of Population Health, The University of Queensland, Brisbane, Au
stralia
Contact address:ChristineTChambers,Department of Psychology,DalhousieUniversity,
Department of Pediatrics (GIDivision), IWK
Health Centre, 5850/5980 University Avenue, P.O. Box 9700, Halifax, Noval Scotia
, B3K 6R8, Canada. christine.chambers@dal.ca.
Editorial group: Cochrane Pain, Palliative and Supportive Care Group.
Publication status and date: New search for studies and content updated (conclus
ions changed), published in Issue 10, 2013.
Review content assessed as up-to-date: 2 September 2013.
Citation: Uman LS, Birnie KA, Noel M, Parker JA, Chambers CT, McGrath PJ, Kisely
SR. Psychological interventions for needlerelated
procedural pain and distress in children and adolescents. Cochrane Database of S
ystematic Reviews 2013, Issue 10. Art. No.:
CD005179. DOI: 10.1002/14651858.CD005179.pub3.
A B S T R A C T
Background
This review is an updated version of the original Cochrane review published in I
ssue 4, 2006. Needle-related procedures are a common
source of pain and distress for children. Our previous review on this topic indi
cated that a number of psychological interventions
were efficacious in managing pediatric needle pain, including distraction, hypno
sis, and combined cognitive behavioural interventions.
Considerable additional research in the area has been published since that time.
Objectives
To provide an update to our 2006 review assessing the efficacy of psychological
interventions for needle-related procedural pain and
distress in children and adolescents.
Search methods
Searches of the following databases were conducted for relevant randomized contr
olled trials (RCTs): Cochrane Central Register of
Controlled Trials (CENTRAL); MEDLINE; EMBASE; PsycINFO; the Cumulative Index to
Nursing and Allied Health Literature
(CINAHL); and Web of Science. Requests for relevant studies were also posted on
various electronic list servers. We ran an updated
search in March 2012, and again in March 2013.
Selection criteria
Participants included children and adolescents aged two to 19 years undergoing n
eedle-related procedures. Only RCTs with at least
five participants in each study arm comparing a psychological intervention group
with a control or comparison group were eligible for
inclusion.
Data collection and analysis
Two review authors extracted data and assessed trial quality and a third author
helped with data extraction and coding for one non-
English study. Included studies were coded for quality using the Cochrane Risk o
f bias tool. Standardized mean differences with 95%
confidence intervals were computed for all analyses using Review Manager 5.2 sof
tware.
hildren and adolescents (Review) 1
Main results
Thirty-nine trials with 3394 participants were included. Themost commonly studie
d needle procedures were venipuncture, intravenous
(IV) line insertion, and immunization. Studies included children aged two to 19
years, with the most evidence available for children
under 12 years of age. Consistent with the original review, themost commonly stu
died psychological interventions for needle procedures
were distraction, hypnosis, and cognitive behavioural therapy (CBT). The majorit
y of included studies (19 of 39) examined distraction
only. The additional studies from this review update continued to provide strong
evidence for the efficacy of distraction and hypnosis.
No evidence was available to support the efficacy of preparation and information
, combined CBT (at least two or more cognitive
or behavioural strategies combined), parent coaching plus distraction, suggestio
n, or virtual reality for reducing children's pain and
distress. No conclusions could be drawn about interventions of memory alteration
, parent positioning plus distraction, blowing out air,
or distraction plus suggestion, as evidence was available from single studies on
ly. In addition, the Risk of bias scores indicated several
domains with high or unclear bias scores (for example, selection, detection, and
performance bias) suggesting that the methodological
rigour and reporting of RCTs of psychological interventions continue to have con
siderable room for improvement.
Authors' conclusions
Overall, there is strong evidence supporting the efficacy of distraction and hyp
nosis for needle-related pain and distress in children
and adolescents, with no evidence currently available for preparation and inform
ation or both, combined CBT, parent coaching plus
distraction, suggestion, or virtual reality. Additional research is needed to fu
rther assess interventions that have only been investigated
in one RCT to date (that is, memory alteration, parent positioning plus distract
ion, blowing out air, and distraction plus suggestion).
There are continuing issues with the quality of trials examining psychological i
nterventions for needle-related pain and distress.
P L A I N L A N G U A G E S U M M A R Y
hildren and adolescents
Psychological interventions (for example, distraction, hypnosis, coping skills t
raining) are treatments used to reduce pain and distress
(anxiety and fear, or both) that children and adolescents experience while under
going medical procedures involving needles. There is
strong evidence that distraction and hypnosis are effective in reducing the pain
and distress that children and adolescents experience
during needle procedures. Distraction techniques can often be quite simple, such
as reading the child stories, watching television,
listening to music, or talking about something other than the needle. Sometimes
parents or nurses are involved in helping to distract
the child, although that is not always necessary. Interventions such as hypnosis
may require some teaching by a trained professional for
a child to learn. Other psychological treatments, such as explaining what is goi
ng to happen before or during the procedure (labelled
'providing information or preparation or both'), using virtual reality (for example,
interactive video equipment, goggles, computers
showing images, games, stories), or a combination of various strategies have bee
n tested.More research is needed to know whether they
are effective for reducing children's pain and distress during needles.
B A C K G R O U N D
This review is an update of a previously published review in the
CochraneDatabase of Systematic Reviews (2006, Issue 4) on 'Psychological
interventions for needle-related procedural pain and
distress in children and adolescents'.
Description of the condition
Medical procedures are a common source of pain and distress
for children. Healthy children undergo immunizations repeatedly
throughout childhood. The Advisory Committee on Immunization
Practices (ACIP 2004), the American Academy of Pediatrics
(AAP 2004), the American Academy of Family Physicians (AAFP
2004), and theCanadian Paediatric Society (CPS 2004) all recommend
over 20 various immunizations before age 18 years.Children
with chronic illnesses experience an even greater number of painful
procedures, as part of the diagnosis, treatment, and monitoring of
their condition. In a hospital setting, children often experience unpredictable
and severe procedure-related pain (Cummings 1996)
that can be associated with negative emotional and psychological
implications (Kazak 2001). Despite the prevalence of pain stemming
from medical procedures and the distress associated with
this, research indicates that painmanagement continues to be suboptimal.
For example, a recent investigation of the epidemiology
and management of painful procedures in children in Canadian
hospitals found that 78% of patients admitted to inpatient units
had undergone a painful procedure; however, less than a third of
the painful procedures had documented pain management interventions
(Stevens 2011).
Evidence-based clinical guidelines for reducing the pain of childhood
vaccinations do exist (Taddio 2010). These guidelines promote
a '3-P' approach to pain management, which includes pharmacological,
physical, and psychological factors. In terms of psychological
approaches, the guidelines recommend various cognitive
and behavioural techniques that are effective at reducing vaccination
pain (for example, deep breathing) as well as various techniques
that are ineffective for vaccination pain (for example telling
children reassuring comments like 'it won't hurt').
Description of the intervention
Medical procedures, particularly needles, are among the most
feared experiences of children (Broome 1990). It is important to
note that identifying positive adaptive or negative maladaptive
intervention strategies should be based on evidence. While intuitively
it might appear that reassurance (for example, saying 'don't
worry' or 'it's going to be ok') would help to decrease pain and
distress during needle procedures, there is a large body of evidence
to indicate that it is actually distress-promoting (for example,
Manimala 2000). Various mechanisms have been proposed
to explain this, including reassurance indicating to the child that
the parent is worried, reinforcement of child distress behaviours
by attention, or permission to the child to freely express his or her
distress (McMurtry 2006; McMurtry 2010).
A number of psychological interventions for managing pain and
distress in children are available, of which the majority are cognitive
behavioural in nature. Although non-pharmacological interventions
for pain that are not cognitive behavioural exist (for
example, acupuncture, heat or cold), these interventions were not
included in the present review. The borderline between psychological
and non-psychological interventions is difficult to define, often
because some interventions could arguably fit into more than
one category. For example, coughing and deep breathing could
both arguably fall under the categories of psychological (for example,
distraction) or physical interventions. We would argue that
the classification of interventions into distinct mutually exclusive
categories would misrepresent the processes involved.
Cognitive interventions include techniques that target negative
or unrealistic thoughts to help replace them with more positive
beliefs and attitudes (for example, saying positive self-statements
such as 'I can get through this' instead of 'this is going to hurt').
Behavioural interventions include techniques that target negative
ormaladaptive behaviours to help replace themwithmore positive
and adaptive behaviours (for example, watching a funny movie
instead of talking about how much the needle will hurt). Cognitive
behavioural therapy (CBT) uses a combination or variation
of cognitive or behavioural, or both, strategies targeting both
thoughts and behaviours (Barlow 1999). CBT for pain management
aims to help individuals develop and use coping skills to
manage their pain and distress, and can include various techniques
such as distraction, relaxation training, deep breathing, hypnosis,
preparing for and rehearsing the procedure in advance, using positive
reinforcement for adaptive behaviours, making positive coping
statements, and receiving coaching to use adaptive strategies
(Chen 2000a; Christophersen 2001; Keefe 1992). While it can
be challenging to identify the exact processes or mechanisms that
each of the interventions target, efficacy is in part a function of
many dimensions such as intervention novelty, engagement, and
developmental appropriateness.
As noted above, although CBT-based interventions are often described
as 'psychological' in nature, this does not mean they are
limited to use or direction by psychologists. On the contrary,most
of these techniques are quite straightforward (for example, distraction,
deep breathing), require no intensive training to use,
and can be delivered by various healthcare workers (for example,
nurses, child life specialists) as well as family members, such
as parents. However, certain techniques do require some training
and knowledge formaximumeffectiveness (for example, diaphragmatic
breathing is more involved than taking a few deep breaths).
Operational definitions of specific cognitive or behavioural interventions
(for example, hypnosis, memory alteration, distraction)
are available by request from the authors.
How the intervention might work
Cognitive interventions include techniques that target negative
or unrealistic thoughts to help replace them with more positive
beliefs and attitudes (for example, saying positive self-statements
such as 'I can get through this' instead of 'this is going to hurt').
Behavioural interventions include techniques that target negative
ormaladaptive behaviours to help replace themwithmore positive
and adaptive behaviours (for example, watching a funny movie
instead of talking about how much the needle will hurt). CBT
uses a combination or variation of cognitive or behavioural, or
both, strategies targeting both thoughts and behaviours (Barlow
1999). For the purpose of this review, all of the cognitive, behavioural,
and cognitive behavioural strategies described above fall
under the overarching category of `psychological' interventions. As
a whole, psychological interventions for pain management aim to
help individuals develop and use coping skills tomanage their pain
and distress, and can include various techniques such as distraction,
relaxation training, deep breathing, hypnosis, preparing for
and rehearsing the procedure in advance, using positive reinforcement
for adaptive behaviours, making positive coping statements,
and receiving coaching to use adaptive strategies (Chen 2000a;
Christophersen 2001; Keefe 1992).
Why it is important to do this review
Several narrative, non-systematic reviews and book chapters on
psychological interventions for the management of procedural
pain and distress in children are available (for example, Alvarez
1997; Blount 2003; Chen 2000a; Christophersen 2001; Devine
2004;Kazak 2001; Powers 1999; Young 2005).These reviews have
typically concluded that psychological interventions are beneficial;
however, the lack of a systematic and pooled approach to integrating
the literature is problematic and can mean that only limited
conclusions regarding the efficacy of these interventions are
made. Although there have been a few examples of more systematic
approaches to integrating this literature (for example, Broome
1989; Kleiber 1999; Luebbert 2001; Saile 1988), these reviews
have tended to adopt a more limited focus (for example, examining
the effects of only one type of intervention such as distraction)
and many are out of date given the rapid growth of research in this
area in recent years.
We conducted and published our original Cochrane Review
(Uman 2006;Uman 2008) to provide a comprehensive, systematic
review of the efficacy of different psychological interventions for
managing procedure-related pain and distress in children. Based
on that original review, we established the efficacy of several interventions
(namely distraction, hypnosis, and CBT) and made
several clinical and research recommendations, including identifying
interventions requiring further research.We also made recommendations
for improving the quality of trials in the area, which
were explored in more depth and outlined in a subsequent paper
(Uman 2010). At the time of our initial review only 28 RCTs met
our inclusion criteria and provided the necessary data for inclusion
in our meta-analysis. Since the publication of our initial review,
considerable additional research in the area has been published.
Therefore, this updated review was meant to expand upon our
original review by identifying and including themore recent RCTs
and synthesizing the results of these more contemporary studies
with our prior work to make stronger conclusions about the efficacy
of these interventions. We also used a risk of bias measure in
this update to evaluate the risk of bias for all of the included studies.
The current updated review combines findings across a larger
sample, which strengthens and expands our conclusions regarding
the efficacy of psychological interventions for needle-related procedural
pain and distress in children and adolescents.
Although we wished to conduct sensitivity analyses to examine
more specific age ranges or developmental periods, the broadness
and variability in the study sample age ranges limited these analyses.
In addition, the majority of RCTs in this area assessed single
event needle procedures rather than repeated or multiple needle
procedures, thereby precluding the ability to assess this area further.
As such, we did not include these analyses in this updated
review but acknowledge the importance of these areas of inquiry
for future research.
O B J E C T I V E S
To provide an update to our 2006 review assessing the efficacy
of psychological interventions for needle-related procedural pain
and distress in children and adolescents.
M E T H O D S
Criteria for considering studies for this review
Types of studies
Only randomized controlled trials (RCTs) with at least five participants
in each study arm were included. In contrast to our original
review in which we included quasi-randomized trials (for example,
alternative assignment) in a sensitivity analysis, for this updated
review we included only true RCT designs and excluded all quasirandomized
trials. A study was deemed to be a true RCT if the
authors explicitly stated that participants were randomly assigned
to groups (for example, assignment was determined using a table
of random numbers) and did not indicate using quasi-randomization
methods (for example, alternating assignment) at any point
in the paper. For example, some authors may describe the study
as an RCT in the title or abstract but later report quasi-randomization
techniques in the methods sections. A true RCT is one
that is described as such throughout the entire paper. While we
were more lenient in the original review and included a few studies
reporting quasi-randomization procedures, these studies were
excluded from the present review in order to be more consistent
and stringent in our approach. In addition, unlike in our original
review, we included only published trials and therefore excluded
any non-published trials (for example, dissertations). No language
restrictions were used during the search and translations were obtained
when necessary.
Types of participants
Studies involving children and adolescents aged two to 19 years
undergoing needle-related medical procedures were included. For
the purposes of this review, a needle-related medical procedure
was defined as any procedure performed as part of a medical diagnosis,
prevention, or treatment. This included dental procedures
(excluding dental surgery) but did not include procedures such
as body piercings or tattoos, which involve needles but are not
performed for medical purposes. The search was limited to needle-
related pain, which is among the most commonly occurring
and feared procedures for both healthy and chronically-ill children
(Broome 1990). Our justification for not including children
less than two years of age is that the majority of psychological
interventions examined in this review are either not appropriate
for use with infants or are qualitatively different when applied to
infants. The efficacy of psychological interventions for procedural
pain and distress in infants has been addressed in another review
(Pillai-Riddell 2011a; Pillai-Riddell 2011b). For both the original
review and this review update, we included studies with participants
ranging from two to 19 years of age. A maximum age of
19 years was chosen to ensure that our search was limited to children
and adolescents only, and is also consistent with the World
HealthOrganization (WHO) definition of adolescence,which defines
it as ranging from 10 to 19 years (http://www.searo.who.int/
en/Section13/Section1245_4980.htm). The age range was kept
broad so as to not exclude any relevant studies; however, studies
that included any participants falling outside of this age range were
excluded unless authors were able to provide data for only the age
range specified for this review while also continuing to meet the
minimum criterion of five participants per group.
We included studies examining medical procedures fromthe same
list of procedures identified in our prior review (please see Table
1 for the list of medical procedures and their definitions). Definitions
were derived from online medical dictionaries (for example,
MedlinePlus Medical Encyclopedia, MedLine 2004; On-
Line Medical Dictionary, OLMD 2004) and by consulting with
medical professionals in the area of pediatric pain. Participants
included healthy children and children with chronic or transitory
illnesses from both inpatient and outpatient settings. Studies including
patients with known needle phobias (that is, diagnosed
by a qualified professional such as a psychologist) were excluded.
While we acknowledge that needle fears are quite prevalent and
some youth included in the reviewed studies may have had undiagnosed
phobias, this criterion was established in an attempt to
distinguish between typical needle fears or ones that are extreme
enough to have warranted assessment and diagnosis prior to the
study. Furthermore, children undergoing surgery were excluded
because numerous factors specific to surgery or being in intensive
care units can complicate and interfere with the accuracy of
self-reported accounts of pain and distress. These factors may include
sedation, inability to verbalize because of intubation, more
intensive pharmacological interventions, long-term hospital stays,
inability or difficulty attributing pain or distress to one specific
medical procedure, and difficulty distinguishing between the pain
and distress caused by the procedure versus the medical condition
requiring the surgery (Puntillo 2004). The exception to this was
for studies that assessed the efficacy of a psychological intervention
for a pre-surgical needle procedure such as an intravenous (IV)
insertion. The outcome measures of interest had to be completed
prior to surgery or sedation in order for the study to be included
in this review.
Types of interventions
Studies were included if at least one trial arm consisted of a psychological
intervention, and there was a comparator control arm,
other active treatment, treatment as usual, or waiting list control.
We excluded studies in which the psychological intervention(s)
was combined with a non-psychological intervention (for example,
pharmacological intervention) when the unique effects of the
psychological intervention could not be evaluated.
Types of outcome measures
The two measured outcomes of interest were pain and distress,
assessed using scales or measures with established reliability and
validity (that is, as evidenced in at least one prior study published
in a peer-reviewed journal). For this review, pain was operationalized
using the definition proposed by the International Association
for the Study of Pain (IASP), describing pain as: an unpleasant
sensory and emotional experience associated with actual or
potential tissue damage, or described in terms of such damage
(IASP 2004). In addition, distress was broadly defined as any type
of negative affect associated with the procedure (for example, anxiety,
stress, fear). Because the main focus of this review was the
data pooling component (that is, the meta-analysis), as with the
original review, RCTs were excluded if the data necessary for data
pooling (for example, means, SDs, cell sizes) were not available in
the published study, could not be identified through contact with
the study authors, or could not be calculated based on other data
provided (for example, confidence intervals).
Primary outcomes
1) Self-report
Measures of pain and distress may include various versions of the
following (Champion 1998):
Visual Analogue Scales (VAS);
Numerical Rating Scales (NRS);
Verbal Rating Scales (VRS);
faces Scales designed to assess level of pain or distress (for example,
anxiety or fear, or both).
2) Observer Global Reports
Observer versions of the self-report measures for pain and distress
listed above (completed by parents, caregivers, nurses, doctors, or
other hospital staff present) were also included. It is important to
note that there are various factors affecting the degree to which
observer reports are positively correlated with self-reports of pain
and distress, such as the person completing the report (that is,
mother, nurse, or doctor) and the age of the child (Champion
1998). Despite these caveats, observer reports of pain and distress
can provide valuable information, particularly for younger children.
3) Behavioural Measures
These include behavioural observation measures, typically completed
by trained researchers or medical staff. They may include
but are not limited to the following commonly used scales
(McGrath 1998).
Pain Scales
The Children's Hospital of Eastern Ontario Pain Scales
(CHEOPS) (McGrath 1985)
The Faces Legs Activity Cry Consolability Scale (FLACC) (
Merkel 1997)
Distress Scales
The Observational Scale of Behavioral Distress (OSBD) (Jay
1983)
The Child-Adult Medical Procedure Interaction Scale
(CAMPIS) (Blount 1989), the CAMPIS-revised (Blount 1990;
Blount 1997), and the CAMPIS-short form (Blount 2001)
While developmental and age factors are important considerations
when selecting appropriate outcome measures, there is still considerable
variability in selecting outcome measures and many are
used for a broad range of ages. However, systematic reviews of selfreport
of pain intensity in youth aged zero to 18 years note that
no scale is uniformly appropriate across development and there
continues to be debate about the choice of scale to use (Stinson
2006; Tomlinson 2010). The more recent Tomlinson 2010 review
suggests that faces scales are frequently used; the most widely
used with the best validity are currently the Faces Pain Scale-Revised
(FPS-R) (Hicks 2001), the Oucher pain scale (Beyer 1992),
and the Wong-Baker Faces Pain Rating Scale (WBFPRS) (Wong
1988). However, it is important to note that several studies have
found that faces scales starting with smiling no-pain anchors, such
as the WBFPRS, tend to result in greater pain ratings compared
to scales starting with neutral non-smiling pain anchors because
they may confound affective states with pain ratings (for example,
Chambers 1998). In addition, although many faces scales are
validated and used with younger children (three to five years), it
has been found that children this young often demonstrate response
biases, such as choosing only the lowest or highest anchors
(for example, von Baeyer 2009). Thus, self-reports of pain from
preschoolers should be interpreted with caution and complementary
observational assessments (for example, by parents) are also
recommended. However, there are systematic discounting biases
in some studies of parental and staff proxy ratings whereby more
weight is given to certain scales or raters (for example, giving more
weight to parent reports and less weight to child reports). For these
reasons, it can be helpful for studies to incorporate various measures
of pain and distress by different raters (for example, child,
parent, staff ) and this is the reason we chose to evaluate these outcomes
separately in this review.
However, is it worth noting that there is also variability among observational
assessments of pain and distress. In another systematic
review of observational (behavioural) measures of pain for youth
three to 18 years old, it was noted that pain intensity measures are
not generally age-normed and there are often no separated versions
of observational scales for different ages. Rather, although
most observational scales were originally developed for specific
ages ranges, they have been applied or expanded to a broader age
range. However, despite this important issue, which warrants further
research, the results of the systematic review did recommend
using certain observational scales (that is, FLACC and CHEOPS)
based on their sound psychometric properties for youth in this age
range undergoing painful medical procedures (von Baeyer 2007).
Secondary outcomes
4) Physiological Measures
Measures of pain and distress that are practical to quantify in
clinical setting may include (Sweet 1998):
heart rate (generally increases with pain);
respiratory rate (may increase or decrease with pain and distress
or both);
blood pressure (generally increases with pain and distress or
both);
oxygen saturation (generally decreases with pain and distress or
both);
cortisol levels (generally increase with pain and distress or both);
transcutaneous oxygen tension (tcPO2) (generally decreases with
pain and distress or both);
transcutaneous carbon dioxide tension (tcPCO2) (may increase
or decrease with pain and distress or both).
Despite concerns regarding the tendency of physiologicalmeasures
to habituate in response to pain and distress, as well as a lack of
data supporting the specificity of thesemeasures to pain (McGrath
1998; Sweet 1998), physiological measures have frequently been
assessed as outcomes in pain studies, and were therefore included
as outcomes in this review. However, it is important to note that
all self- and observer-rated measures of pain and distress are subjective,
given that pain is a subjective experience based on a variety
of factors (for example, pain threshold, previous experiences with
pain, etc).
Search methods for identification of studies
Published studieswere identified by conducting electronic searches
and by contacting researchers using various electronicmailing lists
and list servers.
Electronic searches
Through consultation with a reference librarian and with assistance
fromthe Cochrane Pain, Palliative and Supportive Care (Pa-
PaS) Group, detailed search strategies were developed to search
the following six electronic databases for relevant trials:
Cochrane Central Register of Controlled Trials
(CENTRAL) (The Cochrane Library 2013, Issue 2);
MEDLINE (1966 to March 2013) ;
EMBASE (1989 to March 2013);
PsycINFO (March 2013);
Cumulative Index to Nursing and Allied Health Literature
(CINAHL) (March 2013);
Web of Science (IBI Web of Knowledge) (March 2013).
For this updated review, the same database search terms were used
as in the original review; however, we extended the search date to
cover the period fromwhen the last update ended (2005) toMarch
2013. Thus, altogether, the database searches covered the period
from their inception toMarch 2013. Because we opted to include
only published studies for this current review update, we excluded
one additional database searched in the original review (that is,
Dissertation Abstracts International). A similar search strategy was
adapted for each of the databases but additional related keywords
and MeSH terms were included as appropriate for each specific
database. Please see the appendices for the search strategies and
terms used for each of the databases: MEDLINE (Appendix 1),
PsycINFO (Appendix 2), CENTRAL (Appendix 3), EMBASE
(Appendix 4), IBIWeb ofKnowledge (Appendix 5), andCINAHL
(Appendix 6).
Searching other resources
In addition to the electronic search strategy, we also put out a call
for relevant studies to four e-mail list serves including: 1) Pain in
Child Health (PICH), 2) Pediatric Pain, 3) the American Psychological
Association's Society of Pediatric Psychology Division 54,
and 4) the American Psychological Association's Health Psychology
Division 38. Requests to these list serves were sent out for
both the original review and, again, for the present review update.
Any other relevant studies identified and included in the original
review (for example, fromreference or citation lists) were included
in this update.
Data collection and analysis
1. Selection of studies
Two review authors (LU and CC) independently screened titles
and abstracts of trials from literature searches for inclusion in the
original review, and two additional review authors (MN and KB)
independently screened titles and abstracts for the review update.
For all abstracts that were relevant, potentially relevant, or where
relevance to the current review was unclear, the full articles were
obtained and read by one of the study authors. Using the full
articles, two review authors (LU and CC for the original review,
and MN and KB for the updated review) decided which studies
did and did not meet the inclusion criteria. Review authors were
not blind to the authors, institutions, journals, or results. A third
review author (PMfor the original review, and LU for the updated
review) was brought in to help resolve any issues or selection discrepancies
that arose.
As noted above, to increase themethodological quality of the studies
included in this updated review, we imposed more stringent
inclusion criteria for this review update as compared to the original
review. Specifically, for this review update we omitted any
non-published studies (for example, unpublished dissertations)
and quasi-randomized trials (that is, anything other than reporting
true random assignment, as described above). In our original
review, contact with some study authors clarified that the assignment
they used was indeed random assignment although it was
not described as such in the paper (for example, described in the
abstract as an RCT but described in the methods as using alternating
assignment). Thus, to be consistent across all studies, those
reporting quasi-randomized procedures in the published studies
were excluded from this update even if they were included in the
original review.
A total of 28 RCTs were retrieved and included in the original
review, although for the current update we excluded seven of these
studies because they were unpublished dissertations or reported
quasi-randomized methods (that is, alternating assignment). In
March 2012, our updated search strategy identified 18 additional
RCTs meeting the inclusion criteria and having the necessary data
to be included in this update. An additional search inMarch 2013
did not identify any further studies. Thus, a total of 39 RCTs
(retrieved from the original and updated searches) were included
in this updated review; all of these included RCTs were coded in
full. The references for these studies are all provided below in the
'Description of studies' section.
2. Data extraction and management
Two review authors (LU and CC) extracted data using a data extraction
form designed for the original review, and two additional
review authors (MN and KB) performed data extraction for additional
studies identified in the review update. In addition, another
researcher who was fluent in Farsi confirmed inclusion eligibility
and conducted data extraction for one non-English study identified
from our updated search. Data were extracted on various
details relating to study design, participant demographics, diagnosis
(when applicable), needle procedure, type of intervention and
control conditions, outcomes, as well as other related variables.
A third review author (PM for the original review, and LU for
the updated review) was available to help resolve any coding discrepancies.
Data from the studies were extracted using paper data
extraction sheets developed for this review and were also entered
into electronic spreadsheets to differentiate between included versus
excluded studies. Attempts were made to obtain missing data
(for example, means, SDs, cell sizes) from the authors, whenever
feasible, to include in the meta-analysis. All data for the included
studies were first recorded on paper data extraction forms by review
authors (LU for the original review, and MN and KB for the
updated review) and reviewed for errors by a trained research assistant.
All data suitable for pooling were analysed using RevMan
5.1 software (RevMan 2011).
3. Assessment of risk of bias in included studies
In the original review, each included study was scored independently
for quality by two review authors using theOxfordQuality
Scale created by Jadad 1996. We also completed a more extensive
quality analysis of the included studies (Uman 2010) given that
the Oxford Quality Rating Scale is more appropriate for doubleblind
studies (for example, pharmacological interventions); and
psychological interventions, unlike placebo studies, typically cannot
be truly double-blind. For the purpose of this updated review,
we used the Cochrane 'Risk of bias' tool as a measure of
trial quality. The Cochrane Handbook for Systematic Reviews of Interventions
(www.cochrane-handbook.org/) distinguishes between
methodological quality assessment and risk of bias, and recommends
a focus on the latter (please refer to the Cochrane Handbook
for a detailed account of reasons why). The Risk of bias tool
is a two-part tool assessing seven areas: adequate sequence generation,
allocation concealment, blinding of participants and study
personnel, blinding of outcome assessment, incomplete outcome
data addressed, free of selective reporting, and other biases. All
included studies from the original review and those identified in
this update were independently coded by two review authors (MN
and KB) who then compared responses to reach consensus. This
procedure was verified with, and endorsed by, the Cochrane PaPaS
Review Group.
4. Measures of treatment effect
Given the nature of the outcome measures in this review, all of the
outcome data for the included studies were continuous (for example,
rating scales). Consistent with the analytical approach used in
the original review, and as is recommended by The Cochrane Collaboration,
we computed standardized mean differences (SMD)
with 95% confidence intervals (CI), which allowed us to combine
the results fromdifferent scalesmeasuring the same construct
(for example, pain). We proposed that when sufficient data were
available fromvarious studies using the samemeasurement instruments,
a weighted mean difference (WMD) with 95% CI would
also be conducted. However, given the wide range of different
assessment measures used, this was not feasible. Thus, all mean
differences presented in the tables and plots of the results section
represent SMDs.
Each psychological intervention was assessed separately in a metaanalysis
because the interventions were considered too different
to combine. However, within each intervention we analysed each
outcome measure separately. Thus, for each intervention the following
seven outcomes were separately assessed.
a) Pain: self-reports.
b) Pain: observer global reports.
c) Pain: behavioural measures.
d) Distress: self-reports.
e) Distress: observer global reports.
f ) Distress: behavioural measures.
g) Physiological measures: each physiological outcome (e.g. heart
rate, blood pressure) was assessed separately.
5. Unit of analysis issues
In this context, unit of analysis issues refer to the level at which
randomization occurs. For example, in most situations the number
of observations analysed should match the number of 'units'
that were randomized. In a simple, parallel two-group RCT (intervention
versus control), participants would be randomized to
one of the two groups and a single measurement for each outcome
would be collected and analysed. For the current review, we included
and analysed parallel two-group RCTs as well as clusterrandomized
trials (that is, groups of individuals randomized together
to the same intervention). In addition, we also included
cross-over trials (that is, participants undergomore than one intervention);
however, we only included these studies if the data were
available separately for each group following the first treatment
arm. For example, in a treatment (n = 50) versus control (n = 50)
two-group design we required the data for the first treatment arm
(treatment group versus control) before the groups crossed over
and the conditions were reversed rather than the overall combined
values for all treatment values compared to all control values. The
rationale for this decision was based on the belief that once a psychological
intervention (for example, distraction, hypnosis) has
been introduced and taught to participants, it is difficult to prevent
participants from using these strategies themselves (for example,
cognitive distraction techniques) even if they are then switched
to a control condition. Lastly, we also included studies using repeated
measures designs (for example, pain and distress outcomes
assessed at various time points); however, in these situations we
only included outcomes occurring during the needle procedure
(pre-needle outcomes were not included). If outcomes during the
needle procedure were not evaluated, we then selected the next
proximal time point occurring closest to the completion of the
procedure. If outcomes that assessed both during and following
the needle-related procedure were reported, outcomes during the
needle procedure were selected for inclusion.
6. Dealing with missing data
All included RCTs were reviewed to determine if the authors reported
any missing data. We had originally proposed that data
would not be presented for studies if more than 20% of the originally
randomized participants withdrew; however this was not
applicable to any of the retrieved studies.
In all situations where data necessary for data pooling were omitted
from the published RCT (for example,means, standard deviations
(SDs), groups sizes, CIs), attempts were made to contact the
study authors to obtain these data. If that was not possible, statistical
formulae identified in the Cochrane Handbook for Systematic
reviews of Interventions for calculating missing data using other
reported measures of variation were used (for example, obtaining
standard deviations from standard errors, confidence intervals, t
values, and P values). In situations in which the authors could not
be contacted, did not respond to contact attempts, did not have
these data available, or there were insufficient data available to
compute the necessary calculations, these studies or the outcomes
with the missing data were excluded from this review.
To be consistent with authors' reporting, we included the number
of participants per group identified in the study results sections.
When not otherwise specified by the authors, we assumed that
there were no study dropouts and used the reported group sizes
in the meta-analyses. Initially we intended to conduct all analyses
using intention-to-treat (ITT) analyses. ITT analyses include all
participants enrolled in the study including those who were lost to
follow-up or dropped out.Given that themajority of RCTs did not
specifically identify whether ITT analyses were used and did not
consistently report whether there were any participant dropouts,
ITT analyses could not be performed.
7. Assessment of heterogeneity
For each outcome combining the effects of two or more studies,
we calculated heterogeneity using both the Chi2 test and the I2
statistic. Given that Chi2 tests often have low statistical power, a
type 1 error level of 0.10 was employed for rejecting the null hypothesis
of homogeneity as opposed to the more traditional type
1 error level of 0.05. While Chi2 tests are useful for identifying
whether heterogeneity is present, it has been argued that there
will always be some level of heterogeneity in meta-analyses given
the clinical and methodological diversity (Higgins 2011). The I2
statistic shifts the focus away fromwhether heterogeneity is present
and provides a measure of inconsistency across studies to assess
the impact of heterogeneity on the meta-analysis (Higgins 2011).
I2 is expressed as a percentage from 0 to 100, and the Cochrane
Handbook for Systematic Reviews of Interventions suggests the following
rough interpretation guide: 0 to 40%,might not be important;
30%to 60%, may representmoderate heterogeneity; 50%to
90%, may represent substantial heterogeneity; and 75% to 100%
represents considerable heterogeneity. The reason for some of the
overlap in ranges is because the importance of I2 depends on several
other factors such as themagnitude and direction of effects, as
well as the strength of evidence for the heterogeneity (for example,
the P value for the Chi2 test or the confidence interval for the I2
statistic). In cases where statistically significant heterogeneity was
detected, the data were still pooled; however, these results should
be interpreted with caution. Given that there was significant heterogeneity
for several of the analyses, results were analysed using
a random-effects model. When possible, attempts were made to
explore the reasons for the heterogeneity.We chose only to report
I2 values in the text of the results section but both the I2 statistics
and Chi2 tests are depicted in the forest plot figures.
8. Assessment of reporting biases
In order to help overcome publication bias in both the original
and updated review, we: (1) imposed no language barriers in our
search, (2) contacted several list serves and researchers in the field
of pediatric health and pain to request any published, unpublished,
and in-progress studies, and (3) contacted the authors of
all the studies with missing means, standard deviations, and cell
sizes in attempts to retrieve these data. Of note, many studies
included several outcome measures; however, in some situations
authors only reported means and standard deviations when the
group differences with respect to the intervention were significant,
but not when group differences were not significant. We included
any studies in the meta-analysis that provided completed results
(that is, means, SDs, and cell sizes for both treatment and control
groups) for at least one outcome measure. Information related to
reporting biases is also captured in the Risk of bias tool used to code
all of the included studies reported in this update (studies included
from the original review were also coded for this update using this
tool). Nine of the studies included in this review had authors who
responded to our requests and provided clarification or missing
data (Balan 2009; Bisignano 2006; Caprilli 2007; Cavender 2004;
Gupta 2006; Kleiber 2001; Liossi 1999; McCarthy 2010; Sinha
2006; Wint 2002).
9. Data synthesis
SMDs using a random-effects model for each of the above subcategories
were calculated when the necessary data were available. Interventions
were considered efficacious when the SMD and both
anchors of the CI fell in the negative range. In the original review,
we limited the main analyses to only RCTs but included quasirandomized
trials in sensitivity analyses. Due to the limitations
of quasi-randomized trials, we limited the analyses to only true
RCTs for this review update and did not include the additional
sensitivity analyses for quasi-randomized trials.
In situations where studies included more than one type of control
condition, we selected the condition that was most similar to
the intervention condition, with the only difference being nonadministration
of the specific intervention. Thus, if a study had
three conditions comparing: (1)musicwith headphones, (2) headphones
withoutmusic, and (3) no headphones ormusic, we would
select the headphones without music condition as the appropriate
control condition because it was most similar to the intervention
but just did not include the active ingredient (that is, music). In
addition, it was important to note that some control or standard
care groups included some cognitive or behavioural techniques, or
both. However, we decided a priori to continue to classify these
as control conditions since they were determined to be part of
standard care and were conceptualized as control conditions by
the study authors. In addition, and as noted above, if the control
condition included a pharmacological component (for example,
lidocaine and prilocaine eutectic mixture (EMLA), a cream used
for local anaesthesia), this was still conceptualized as a control
condition provided that the intervention group also received the
same pharmacological component plus a psychological intervention.
The implications of these types of control conditions are further
explored in the discussion section of this review.
Consistent with the original review, when a single study provided
more than one observer rating of the same construct (for example,
both parent and nurse VAS ratings of child pain) or more
than one behavioural measure for the same construct (for example,
CAMPIS and OSBD measures to assess distress), these measures
were pooled using statistical formulae recommended by The
Cochrane Collaboration for combining means and SDs. This was
done in order to be able to summarize the large amount of data
reported in these studies. The formulae we used to poolmeans and
SDs were the following: pooled mean = [(mean1 x N1) + (mean2
x N2) / (N1 + N2)] and pooled SD = square root of [SD12 (N1 -
1) + SD22 (N2 - 1)] / N1 + N2 -2.
As previously indicated, for studies that included outcomes for numerous
time points we restricted our analyses to the measurement
occurring during the procedure or, if that was not provided, we
used the first post-proceduremeasurement. For example, if a study
included procedural measures (taken during the needle) and postproceduralmeasure
s
(taken after the needle), we included only the
former in our analyses. For studies that included only post-needle
measures but provided them at several time points (for example,
immediately after needle, one minute later, five minutes later),
we included the first measure or the outcome assessed as soon as
possible following the needle. Pre-procedural measures of pain or
distress were not analysed as the focus of this review was on pain
and distress reduction during needle procedures.
10. Subgroup analysis and investigation of
heterogeneity
As with the original review, subgroup analyses were limited to
analysing each category of psychological intervention separately
(for example, distraction RCTs, hypnosis RCTs, etc) as the interventions
were considered too qualitatively distinct to combine,
and overall analyses including all RCTs would not be as meaningful.
In addition, as mentioned above, within each intervention
category analyses were broken down by outcome category (pain
versus distress outcomes) and within each of those categories they
were further broken down by outcome measure (that is, self-report,
observer-report, behavioural rating scales, and physiological
interventions). Physiological outcomes were further analysed
separately as they represented distinct functions or processes (for
example, heart rate versus blood pressure). For all outcomes, the
Chi2 test and I2 statistic of heterogeneity were carried out as previously
described.
11. Sensitivity analysis
In our original review, we were unable to conduct all of the sensitivity
analyses that we proposed due to insufficient data reported
within and across studies, as well as the small number of studies
within each intervention category. The main sensitivity analyses
we conducted in the original review involved comparing the study
results when quasi-randomized trials were added to the analyses.
However, in order to strengthen themethodological quality of the
findings for this updated review, we limited the included trials
to only true RCTs that explicitly stated that true random assignment
was conducted. As a result, the four studies with alternating
assignment included in the sensitivity analyses of the original
review were omitted from this updated review (Christiano 1996;
MacLaren 2005; Manne 1990; Sparks 2001).
R E S U L T S
Description of studies
Results of the search
Three electronic database searches were conducted: one for the
original review (February 2005) and three for the updated review
(December 2010, March 2012, March 2013). In the original review
(Uman 2006; Uman 2008), 29 papers representing 28 separate
studies were included. Of these, four were excluded from this
review update because they did not report adequate randomization
procedures in the paper (Cohen 1997; Cohen 2001; Cohen
2002; French 1994) and three were excluded because they were
unpublished dissertation theses (Krauss 1996; Posner 1998; Zabin
1982). Of note, the Cohen 2001 (Cohen 2001) study was listed
in the original review as Cohen 1999 (Cohen 1999) because both
studies reported on the same sample; however, it was only counted
as one study. Thus, a total of 21 studies from the original review
were included in this update.
We initiated an updated search of the six databases from 2005
(inclusive) onwards in December 2010, yielding a total of 1338
abstracts which were reviewed. To account for the time taken to
review these abstracts and work on other components of this review,
we also conducted searches of the databases in March 2012
and March 2013 to identify any new studies published since December
2010. These latter two searches yielded an additional 639
abstracts. A total of 1977 abstracts were reviewed for this review
update. Of these abstracts, 90 studies were identified as potentially
meeting the inclusion criteria; however two of these studies
were previously identified and included in our original review
(Liossi 2006; Tak 2006) and one study was not identified in the
original review search (Klingman 1985). Not accounting for the
two studies already included in our original review (Liossi 2006;
Tak 2006), this resulted in 88 studies identified in these updated
searches that were reviewed in full based on their abstracts.
Our original search retrieved one non-English study reported in
Portuguese, which was translated into English (Santos 1999). Our
updated search retrieved two non-English studies reported in Farsi
(Shahabi 2007; Vosoghi 2010), which needed to be reviewed in
full. We obtained the assistance of a translator recommended by
The Cochrane Collaboration who confirmed that one of these
studies met our inclusion criteria (Vosoghi 2010). He then completed
the data extraction form and Risk of bias tool for this study.
In reviewing this study, he also identified an additional study in
Farsi which potentially met our inclusion criteria (Alavi 2005).
The two studies (Alavi 2005; Shahabi 2007) were excluded because
they employed cross-over designs and data were not available
pre-crossover, such that the studies could not be assessed as
RCTs. In addition, our updated search identified two studies in
German (Hoffman 2011; Kammerbauer 2011) and two in Italian
(Bufalini 2009; Lessi 2011), which we had informally reviewed by
researchers fluent in these languages; however, none of these studies
met our inclusion criteria. One of these studies was excluded
because the groups received general anesthesia or conscious sedation
(Bufalini 2009) and the other three were excluded because
they were not true RCTs (Hoffman 2011; Kammerbauer 2011;
Lessi 2011). In total, of the 88 studies identified from these updated
searches, 18 studies met our inclusion criteria and provided
the data necessary for data pooling.
Included studies
Overall, this updated review included 21 studies from the original
review (Blount 1992; Cassidy 2002; Cavender 2004; Chen 1999;
Eland 1981; Fanurik 2000; Fowler-Kerry 1987; Gonzalez 1993;
Goodenough 1997; Harrison 1991; Katz 1987; Kleiber 2001;
Kuttner 1987; Liossi 1999; Liossi 2003; Liossi 2006; Press 2003;
Tak 2006; Tyc 1997; Vessey 1994; Wint 2002) in addition to 18
studies from the updated searches from December 2010, March
2012, and March 2013 (Balan 2009; Bellieni 2006; Bisignano
2006; Caprilli 2007; Gold 2006; Gupta 2006; Huet 2011; Inal
2012; Jeffs 2007; Kristjansdottir 2010; Liossi 2009; McCarthy
2010; Nguyen 2010; Noguchi 2006; Sinha 2006; Vosoghi 2010;
Wang 2008;Windich-Biermeier 2007) for a total of 39 studies (N
= 3584 participants) reported in this updated review and metaanalysis.
Of the 39 included studies, most had intervention arms examining
distraction only (n = 20), followed by hypnosis (n = 7), CBTcombined
(n = 4), parent coaching plus child distraction (n =
3), suggestion only (n = 3), preparation and information (n = 2),
virtual reality (n = 2); and memory alteration, parent positioning
plus child distraction, blowing out air, and distraction plus
suggestion (n = 1 each). Needle procedures varied and included
venipuncture (n = 13), IV insertion (n = 7), immunization (n = 6),
lumbar puncture (n = 5), bone marrow aspiration (n = 2); and intramuscular
injection, local dental anesthetic, injection for allergy
testing, laceration repair (n = 1 each). Additionally, participants
in one study received either a venipuncture or IV insertion, and
in another study they received bone marrow aspiration or lumbar
puncture. Included studies also varied significantly in the age of
recruited participants. The majority of studies (n = 22) focused
on preschool (two to five years old) or school-aged children only
(that is, six to 12 years old). Two studies included preschoolers and
up to age 13 years. Fourteen studies recruited a wide age range of
participants crossing preschool, school age, and adolescence (that
is, anywhere from two to 19 years old). Only one study focused
exclusively on adolescents (that is, 13 to 15 years old), which examined
distraction. Interventions involving parent coaching or
parent positioning combined with child distraction generally included
preschool or school-aged children only, with the exception
of one study which included children and adolescents (that is, 5
to 18 years old). Otherwise, types of interventions examined were
distributed across the age ranges. All studies included both boys
and girls, with three studies not reporting the sex of participants.
Please refer to the 'Characteristics of included studies' table for additional
detail, including the intervention and control conditions
for each of these studies. For consistency, these are described using
the authors' wording provided in published reports.
Excluded studies
Of the 188 studies identified and reviewed in full in the original
review, 51were excluded because they did notmeet all of the inclusion
criteria or failed to provide the data necessary for data pooling.
Furthermore, as noted above, eight papers representing seven
studies that were included in the original review were excluded
from this review update because they did not report adequate randomization
procedures in the paper or they were unpublished dis-
sertation theses (Cohen 1997; Cohen 1999; Cohen 2001; Cohen
2002; French 1994;Krauss 1996; Posner 1998;Zabin 1982).Thus
a total of 58 studies identified in the original review search were
excluded in this update. Of the 88 studies identified and reviewed
in full for this review update, 70 were excluded because they did
not meet all of the inclusion criteria or did not report data necessary
for data pooling. Thus a total of 128 studies from the original
and updated searches were excluded after the full articles were
reviewed. Reasons for exclusion are provided below as well as in
the `Characteristics of excluded studies' table.
Primary reasons for exclusion fell into the following categories:
not a randomized controlled trial, reported assignment not
truly random, quasi-randomized assignment (n = 47) (Alhani
2010; Ashkenzai 2006; Atkinson 2009; Bagnasco 2012; Boivin
2008; Christiano 1996; Cline 2006; Cohen 1997; Cohen 2001;
Cohen 2002; Cohen 2010; Crowley 2011; Davit 2011;
Dufresne 2010; French 1994; Heckler-Medina 2006; Heden
2009; Hoffman 2011; Howe 2011; Kammerbauer 2011; Lawes
2008; Lessi 2011; Liossi 2007; MacLaren 2005; MacLaren 2007;
Manimala 2000; Manne 1990; Manne 1994; McInally 2005;
Nilsson 2009; Olsen 1991; Powers 1993; Ramponi 2009;
Rogovik 2007; Schechter 2010; Schur 1986; Sikorova 2011;
Slifer 2011; Sparks 2001; Stefano 2005; Sury 2010; Thurgate
2005; Tufekci 2009; Vohra 2011; Wood 2002; Yoo 2011; Zahr
1998);
met inclusion criteria but missing data necessary for
pooling, such as means, SDs, and cell sizes (n = 23) (Arts 1994;
Bengston 2002; Carlson 2000; Chen 2000b; Dalhquist 2002;
Fassler 1985; Gilbert 1982; Goymour 2000; Inal 2010; Jay
1987; Kazak 1996; Kazak 1998; Klingman 1985; Kuttner 1988;
Malone 1996; Megel 1998; O'Laughlin 1995; Peretz 1999; Reeb
1997; Santos 1999; Vernon 1974; Young 1988; Zeltzer 1982);
older than included age range or adult sample (n = 11)
(Agarwal 2008; Anson 2010; Drahota 2008; Jacobson 2006;
Kwekkeboom 2003; Salih 2010; Schneider 2011; Shabanloei
2010; Shimizu 2005; Slack 2009; Vika 2009);
no control or comparison group or inappropriate control
group (n = 8) (Broome 1998; Hawkins 1998; Jay 1995; Kolk
2000; Slifer 2009; Smith 1989; Smith 1996; Wall 1989);
surgical procedure (n = 5) (Hatava 2000; Klorman 1980;
Lustman 1983; Melamed 1974; Winborn 1989);
non-published dissertation study (n = 4) (Krauss 1996;
Myrvik 2009; Posner 1998; Zabin 1982);
inappropriate intervention or could not isolate effects of
psychological components from multi-component intervention
(n = 3) (Baxter 2011; Jay 1991; Stevenson 2005);
inappropriate outcome measures or outcomes not related to
pain or anxiety (n = 3) (Alderfer 2010; Bruck 1995; Jay 1990);
intervention not primarily psychological (n = 5)
(Anghelescu 2013; Demir 2012; Marec-Berard 2009; Park 2008;
Wallace 2010);
no needle procedure (n = 3) (Kettwich 2007; Weber 2010;
Weinstein 2003);
use of general anesthesia or conscious sedation prior to
needle procedure (n = 2) (Bufalini 2009; Kain 2006);
failed randomization (n = 2) (Bowen 1999; McCarthy
1998);
conference presentation abstract or not a published RCT (n
= 3) (Bufalini 2012; Inal 2010; Russell 2012);
cross-over design with data not available pre-crossover (n =
3) (Alavi 2005; El-Sharkawi 2012; Shahabi 2007);
younger than included age range or infant sample (n = 2)
(Cramer-Berness 2005; Ozdemir 2012);
fewer than five participants per condition (n = 1) (Pederson
1996);
only one group received an adjunct pharmacological
intervention (n = 1) (Berberich 2009);
results not presented separately as control versus treatment
group or secondary analysis and original study included in
review (n = 1) (McCarthy 2010b);
secondary data analysis and original study not included in
review (n = 1) (Dalhquist 2005).
Risk of bias in included studies
All of the 39 studies included in this review were coded using seven
`Risk of bias' categories, which included: 1) random sequence generation
(selection bias), 2) allocation concealment (selection bias),
3) incomplete outcome data addressed (attrition bias), 4) free of
selective reporting, 5) free of other bias, 6) blinding of participants
and personnel (performance bias), and 7) blinding of outcome assessment
(detection bias). Risk of bias results are depicted in Figure
1 and Figure 2. For random sequence generation, 15 of the studies
were rated as having a low risk of bias, none were rated as having
a high risk of bias, and 24 were rated as unclear. For allocation
concealment, two of the studies were rated as having a low risk of
bias, seven were rated as having a high risk of bias, and 30 were
rated as unclear. For incomplete outcome data addressed, 30 of
the studies were rated as having a low risk of bias, three were rated
as having a high risk of bias, and six were rated as unclear. For free
of selective reporting, one of the studies was rated as having a low
risk of bias, 16 were rated as having a high risk of bias, and 22 were
rated as unclear. For free of other bias, five of the studies were rated
as having a low risk of bias, 21 were rated as having a high risk of
bias, and 13 were rated as unclear. For blinding of participants and
personnel, none of the studies were rated as having a low risk of
bias, 37 were rated as having a high risk of bias, and two were rated
as unclear. This result was expected given that it is not typically
feasible to blind participants and personnel when conducting psychological
interventions. However, we decided to code this itemas
we did not want tomiss any studies where theymay have been able
to achieve blinding through creative methodology. For example,
in theory, a study could achieve blinding of participants and personnel
if the intervention involved parenting coaching or training
in the use of distraction whereby participants (children receiving
the injection) and personnel (nurses administering the injection)
were unaware of the intervention. For blinding of outcome assessment,
one of the studies was rated as having a low risk of bias,
36 were rated as having a high risk of bias, and two were rated
as unclear. Again, although it is rare and challenging to achieving
blinding of outcomes for psychological interventions, it is also
possible. For example, if a study assessed an intervention involving
nurse coaching or training in the use of distraction whereby parents
and children were not made aware that distraction was being
used as an intervention, and if the outcomes assessed were only
completed by the children and parents, this study would achieve
blinding of outcome assessment. Another example could involve a
situation in which observer ratings are conducted based on a video
recording of the needle procedure where the observer is blind to
the intervention used and the type of intervention received is not
discernible from the video.
Figure 1. Risk of bias graph: review authors' judgments about each risk of bias it
em presented as
percentages across all included studies.
Figure 2. Risk of bias summary: review authors' judgments about each risk of bias
item for each included
study.
All of the 21 analyses reported below were assessed for heterogeneity.
Of these 20 analyses: five had I2 values of 0% suggesting that
heterogeneity might not be important; one had an I2 value below
30%, one had an I2 value between 30% and 50%, which may
represent moderate heterogeneity; 11 had I2 values between 50%
and 90%inclusive,whichmay represent substantial heterogeneity;
and three had I2 scores above 90%, which indicated considerable
heterogeneity.
Effects of interventions
Distraction
As with our original review, themost evidence in terms of number
of published RCTs existed for the efficacy of distraction on selfreported
pain. In total, there were 19 included studies examining
the effects of distraction, although one of the studies (Bellieni
2006) involved two distraction groups using different strategies.
The distraction techniques in these studies involved: listening to
music (n = 5) (Balan 2009; Caprilli 2007; Kristjansdottir 2010;
Nguyen 2010; Press 2003), watching cartoons (n = 4) (Bellieni
2006; Cassidy 2002; Tak 2006; Wang 2008), playing with a toy
(n = 2) (Vessey 1994; Vosoghi 2010), non-procedural talk (n = 1)
(Gonzalez 1993), squeezing a rubber ball (n = 1) (Gupta 2006),
using cards with questions on them (n = 1) (Inal 2012), listening
via earphones to stories being sung or read (n = 1) (Noguchi 2006),
mother distraction including speaking, caressing, and soothing (n
= 1) (Bellieni 2006), or a combination or selection of various distractors
such as toys, books, cartoons, games, or music (n = 4)
(Fanurik 2000; Jeffs 2007; Kuttner 1987; Sinha 2006). Thus, distraction
interventions varied widely regarding the degree of passive
or active involvement of the child, parental, or health professional
involvement, or opportunity for the child to choose a distractor.
Of these 19 studies examining distraction, the needle procedures
included venipuncture or blood draw only (n = 8) (Balan
2009; Bellieni 2006; Caprilli 2007; Inal 2012; Press 2003; Tak
2006; Vessey 1994; Wang 2008), immunization or injection (n =
4) (Cassidy 2002; Gonzalez 1993; Kristjansdottir 2010; Noguchi
2006), IV insertion (n = 2) (Fanurik 2000; Vosoghi 2010), laceration
repair (n = 1) (Sinha 2006), venipuncture via venous cannulation
(n = 1) (Gupta 2006), allergy testing involving injection (n
= 1) (Jeffs 2007), bone marrow aspiration (n = 1) (Kuttner 1987),
and lumbar puncture (n = 1) (Nguyen 2010). Although the age
ranges across the studies were quite broad and varied considerably,
all of the studies included children 12 years and younger as
part of the sample with the exception of one study (Kristjansdottir
2010), which only examined adolescents aged between 13 and
15 years. Of the remaining 18 studies that included children 12
and under, five of these also included adolescents aged up to 18
years (Caprilli 2007; Fanurik 2000; Jeffs 2007; Press 2003; Sinha
2006) while five studies only included children seven years and
younger (Cassidy 2002; Gonzalez 1993; Kuttner 1987; Noguchi
2006; Vosoghi 2010). The variance in age ranges between and
within studies and variability in type of needle procedures limits
our ability to make age- or procedure-specific conclusions or recommendations.
Nineteen studies with a total of 1759 participants were entered
into the analysis of the effects of distraction on self-reported pain,
resulting in a SMD of -0.61 (95% CI -0.91 to -0.32) and an
I2 of 88%. This effect was significant (Z = 4.08, P < 0.0001)
(Analysis 1.1). Five studies with a total of 447 participants were
entered into the analysis of the effects of distraction on observerreported
pain, resulting in a SMD of -0.87 (95% CI -1.75 to
0.02) and an I2 of 94%. This effect was marginally significant
(Z = 1.92, P = 0.05) (Analysis 1.2). Three studies with a total of
286 participants were entered into the analysis of the effects of
distraction on self-reported distress, resulting in a SMD of -0.66
(95% CI -1.37 to 0.06) and an I2 of 87%. This effect was not
significant (Z = 1.79, P = 0.07) (Analysis 1.3). Two studies with a
total of 363 participantswere entered into the analysis of the effects
of distraction on observer-reported distress, resulting in a SMD of
-1.15 (95% CI -2.73 to 0.42) and an I2 of 97%, suggesting there
is considerable heterogeneity in this analysis. This effect was not
significant (Z= 1.44, P = 0.15) (Analysis 1.4). Two studies with a
total of 152 participantswere entered into the analysis of the effects
of distraction on behavioural measures of pain, resulting in a SMD
of -0.15 (95%CI -0.69 to 0.40) and an I2 of 62%. This effect was
not significant (Z = 0.53, P = 0.59) (Analysis 1.5). Five studies
with a total of 254 participantswere entered into the analysis of the
effects of distraction on behavioural measures of distress, resulting
in a SMD of -0.30 (95% CI -0.76 to 0.16) and an I2 of 63%.
This effect was not significant (Z = 1.28, P = 0.20) (Analysis 1.6).
Two studies with a total of 112 participants were entered into the
analysis of the effects of distraction on the physiological measure
of heart rate, resulting in a SMD of -0.70 (95% CI -1.08 to -
0.32) and an I2 of 0%. This effect was significant (Z = 3.58, P =
0.0003) (Analysis 1.7).Two studieswith a total of 112 participants
were entered into the analysis of the effects of distraction on the
physiological measure of oxygen saturation, resulting in a SMD
of 0.60 (95% CI 0.22 to 0.98) and an I2 of 0%. This effect was
significant (Z = 3.10, P = 0.002) (Analysis 1.8). There was only
one study that could be analysed for the effects of distraction
on the physiological measures of respiratory rate, systolic blood
pressure, and diastolic blood pressure (Nguyen 2010), therefore
no additional conclusions could be drawn. Sample size, means,
and SDs for these outcomes are available in Table 2.
Hypnosis
As with our original review, of all of the interventions assessed
hypnosis had the largest significant effect sizes across several outcomes.
Five studies with a total of 176 participants were entered
into the analysis of the effects of hypnosis on self-reported pain,
resulting in a SMD of -1.40 (95% CI -2.32 to -0.48) and an I2 of
85%. This effect was significant (Z = 2.97, P = 0.003) (Analysis
2.1). Five studies with a total of 176 participants were entered
into the analysis of the effects of hypnosis on self-reported distress,
resulting in a SMD of -2.53 (95% CI -3.93 to -1.12) and an I2 of
91%. This effect was significant (Z = 3.53, P = 0.0004) (Analysis
2.2). Six studies with a total of 193 participants were entered into
the analysis of the effects of hypnosis on behavioural measures of
distress, resulting in a SMD of -1.15 (95% CI -1.76 to -0.53) and
an I2 of 71%. This effect was significant (Z = 3.66, P = 0.0003)
(Analysis 2.3). There was only one study that could be analysed for
the effects of hypnosis on either observer-reported distress (Katz
1987) or behavioural measures of pain (Huet 2011), therefore no
additional conclusions could be drawn. Sample size, means, and
SDs for these outcomes are available in Table 2.
Preparation and information
analysis of the effects of preparation and information on self-reported
pain, resulting in a SMD of -0.22 (95% CI -1.20 to 0.76)
and an I2 of 88%. This effect was not significant (Z = 0.43, P
= 0.66) (Analysis 3.1). There was only one study that could be
analysed for the effects of preparation and information on observer-
reported pain, observer-reported distress, and the physiological
measure of pulse rate (Harrison 1991), as well as only one
study for behavioural measures of distress (Tak 2006). Therefore
no additional conclusions could be drawn. Sample size, means,
and SDs for these outcomes are available in Table 2.
Virtual reality
analysis of the effects of virtual reality on self-reported pain, resulting
in a SMD of -0.23 (95% CI -0.79 to 0.33) and an I2 of
0%. This effect was not significant (Z = 0.80, P = 0.42) (Analysis
4.1).
Combined Cognitive Behavioural
Intervention/Treatment (CBT)
The interventions in this category of cognitive behavioural interventions
were heterogeneous as they involved different combinations
of cognitive and behavioural components. Three studies
with a total of 250 participants were entered into the analysis of
the effects of CBT on self-reported pain, resulting in a SMD of -
0.59 (95%CI -1.62 to 0.44) and an I2 of 86%. This effect was not
significant (Z = 1.12, P =0.26) (Analysis 5.1). Three studies with
a total of 105 participants were entered into the analysis of the
effects of CBT on self-reported distress, resulting in a SMD of -
0.50 (95%CI -1.08 to 0.07) and an I2 of 47%. This effect was not
significant (Z = 1.72, P = 0.08) (Analysis 5.2). Two studies with a
total of 84 participants were entered into the analysis of the effects
of CBT on observer-reported distress, resulting in a SMD of 0.04
(95% CI -0.87 to 0.95) and an I2 of 75%. This effect was not
significant (Z = 0.08, P = 0.93) (Analysis 5.3). Lastly, four studies
the effects of CBT on behavioural measures of distress, resulting
in a SMDof -0.54 (95%CI -1.16 to 0.09) and an I2 of 71%. This
effect was not significant (Z = 1.69, P = 0.09) (Analysis 5.4).
Parent coaching + child distraction
Three studies with a total of 612 participants were entered into the
analysis of the effects of parent coaching plus child distraction on
self-reported pain, resulting in a SMD of 0.06 (95% CI -0.19 to
0.31) and an I2 of 24%. This effectwas not significant (Z = 0.46, P
= 0.65) (Analysis 6.1). Two studies with a total of 581 participants
were entered into the analysis of the effects of parent coaching plus
child distraction on observer-reported distress, resulting in a SMD
of -0.04 (95% CI -0.21 to 0.12) and an I2 of 0%. This effect was
not significant (Z = 0.52, P = 0.60) (Analysis 6.2). Three studies
the effects of parent coaching plus child distraction on behavioural
measures of distress, resulting in a SMDof -0.36 (95%CI -0.97 to
0.25) and an I2 of 83%. This effect was not significant (Z = 1.16,
P = 0.25) (Analysis 6.3). There was only one study that could be
analysed for the effects of parent coaching plus child distraction
on either self-reported distress (Windich-Biermeier 2007) or the
physiological measure of cortisol responsivity (McCarthy 2010),
therefore no conclusions could be drawn. Sample size, means, and
SDs for these outcomes are available in Table 2.
Suggestion
Three studies with a total of 218 participants were entered into the
analysis of the effects of suggestion on self-reported pain, resulting
in a SMD of -0.13 (95% CI -0.40 to 0.15) and an I2 of 0%.
This effect was not significant (Z = 0.90, P = 0.37) (Analysis
7.1). There was only one study that could be analysed for the
effects of suggestion on observer-reported pain and self-reported
distress (Goodenough 1997), aswell as only one study for observerreported
distress (Eland 1981); therefore no additional conclusions
could be drawn. Sample size,means, and SDns for these outcomes
are available in Table 2.
Parent positioning + child distraction
Only one study provided outcome measures for the effects of
parent positioning plus child distraction on pain and distress
(Cavender 2004), therefore no conclusions could be drawn. Sample
size, means, and SDs for these outcomes are available in Table
2.
Memory alteration
Only one study provided outcomemeasures for the effects ofmemory
alteration on pain and distress (Chen 1999), therefore no conclusions
could be drawn. Sample size, means, and SDs for these
outcomes are available in Table 2.
Blowing out air
The one study analysing this intervention in the original review
was excluded from this update because of our revised inclusion
criteria (that is, the allocation procedure not described as truly random
in the study). There was only one additional study analysing
this intervention identified from the updated searches (Gupta
2006), therefore no conclusions could be drawn. Sample size,
means, and SDs for these outcomes are available in Table 2.
Distraction + suggestion
Only one study provided outcome measures for the effects of distraction
plus suggestion on pain (Fowler-Kerry 1987), therefore
no conclusions could be drawn. Sample size, means, and SDs for
these outcomes are available in Table 2.
Nurse coaching + distraction
The two studies assessing nurse coaching plus distraction thatwere
included in the original review were excluded from this review
because of our revised inclusion criteria, explained above (that is,
the allocation procedure was not described as truly random in the
study). Since no studies assessing this intervention category were
identified fromour updated search strategy, therewere no available
data to assess the efficacy of this intervention. Please refer to the
original review formore information on our previous findings and
conclusions prior to conducting this updated review (Uman 2006;
Uman 2008).
Videotaped modelling + parent coaching
The one study assessing videotaped modelling plus parent coaching
included in the original review was excluded from this review
because of our revised inclusion criteria (that is, non-published
dissertation study). Since no studies assessing this intervention category
were identified from our updated search strategy, there were
no available data to assess the efficacy of this intervention.
Filmed Modeling
The one study assessing filmed modelling that was included in the
original review was excluded from this review because of our revised
inclusion criteria (that is, non-published dissertation study).
Since no studies assessing this intervention category were identified
from our updated search strategy, there were no available data
to assess the efficacy of this intervention.
D I S C U S S I O N
Summary of main results
This review synthesizes the results of 39 RCTs; 21 identified from
the original review (Uman 2006) and an additional 18 identified
from this update. By including only true randomized controlled
trials published in peer-reviewed journals, this review offers a rigorous
systematic examination of the efficacy of psychological interventions
for reducing needle-related pain and distress in children
and adolescents.Our results showstrong evidence supporting
the efficacy of distraction and hypnosis. More specifically, trials
support the use of distraction for reducing pain, and hypnosis for
the reduction of both pain and distress. Despite the availability of
two to four RCTs for each type of intervention, no evidence was
available to support the efficacy of preparation and information,
combined CBT, parent coaching plus distraction, suggestion, or
virtual reality for reducing children's pain and distress. Our original
review (Uman 2006) identified sufficient evidence supporting
combined CBT; however, due to the more stringent inclusion criteria
of this update, three trials examining combined CBT were
removed (Cohen 1997; Cohen 2002; Posner 1998) and two new
trials (Bisignano 2006;Wang 2008) were identified in the updated
searches. Given this new evidence, the efficacy of combined CBT
was no longer supported. No conclusions could be made about
the efficacy of memory alteration, parent positioning plus distraction,
blowing out air, or distraction plus suggestion due to the
availability of single trials only in those areas.
Although this review continues to provide strong evidence for the
efficacy of distraction as awhole, significantly variabilitywas noted
in the distraction methods described in the 20 trials reporting
on distraction interventions. We are still lacking clear evidence
to identify whether the type of distraction influences its efficacy
across child development, and with different needle procedures.
Although the type of distraction varies, themajority of the evidence
for distraction to date is with school-aged children (that is, ages six
to 12 years), but it is supported by studies including children from
two to 19 years old. Future studies clarifying these distinctions
are necessary to empirically inform more targeted analyses and
treatment recommendations.
Overall, hypnosis had the largest effect sizes for reducing pain and
distress during needle-related procedures; however, it is important
to note that the majority of these trials have been published by the
same research group. As such, this raises questions about the generalizability
and efficacy of this approach when administered by
different providers in different pediatric settings. Future research
should assess the efficacy of hypnosis in different settings, including
multi-site trials with multiple therapists, in order to provide
additional support for the generalizability of these intervention
approaches. Furthermore, hypnotisability appears related to the
magnitude of treatment benefit (Liossi 2003). Therefore, hypnosis
may not be effective for children who have low hypnotisability.
This highlights the important point of needing to not only examine
intervention efficacy overall but also to consider and evaluate
the match between intervention type and child characteristics.
Overall completeness and applicability of the
evidence
This review enables identification of current trends in pediatric
acute pain research. Since the publication of the original review,
we have noted a decrease in use of classic no-treatment control
groups, defined as the absence of psychological and pharmacological
pain management, as well as the increased use of topical anesthetics
as part of standard care. This is likely due, in part, to the
dissemination of advances in pediatric pain management through
publication and endorsement of clinical practice guidelines and
position statements (Taddio 2010). Indeed, withholding topical
anesthetics and non-pharmacological intervention in the face of a
strong evidence base for their effectiveness is widely and accurately
justified as unethical (Anderson 2005;WorldMedical Association
2008). However, this shift also has practical research implications.
Comparison of interventions with other effective treatments will
make it more difficult to detect treatment effects; as such, the field
may need to apply new parameters in determining the degree of
treatment efficacy (for example, non-inferiority trials). Furthermore,
the use of topical anesthetics needs to be measured and controlled
for in future trials as their use in standard caremay vary, and
they are not uniformly given to all children (Windich-Biermeier
2007; Wint 2002), thereby potentially contaminating the group
of additional psychological interventions. While the decreased use
of no-treatment control groups and increased use of topical anesthetics
may reflect a trend towards increased use of evidence-based
strategies, continued suboptimal acute pain assessment and management
(Stevens 2012;Taddio 2009) suggests that this knowledge
is not being widely translated into implementation by providers
and families. While the results of this review provide information
about research trends, it may not accurately represent what it being
implemented in actual clinical practice around the world.
Although the results of this review are based on 39 trials, the
vast majority of studies continue to investigate the efficacy of distraction.
Rather than continuing to examine a mix of distractors,
we argue that the field would benefit more from studies systematically
comparing and dismantling the effective aspects of distraction
techniques. For example, more recent trials have begun
distinguishing between àctive' distraction, which engages more
senses and requires more patient engagement (for example, playing
a video game) versus 'passive' distraction where the patient
is less actively involved (for example, watching television (TV)).
This warrants further investigation as experimental research has
shown that active or interactive (as compared to passive) virtualreality
based distraction was more efficacious for reducing pain
in children (Dalhquist 2007). However, a systematic review of
music therapy for painful medical procedures in children found
that passive music therapy was as effective as active music therapy
(Klassen 2008). Research is also needed to identify the impact of
distraction novelty on intervention efficacy as it has been proposed
that interventions involving novel materials or activities are more
effective at capturing a child's attention (Sinha 2006; Slifer 2002).
Furthermore, the role of child preference or choice in distractors
is also of interest given that older and younger children tend to
select different distractors when given the choice (Sinha 2006;
Windich-Biermeier 2007). A number of included trials involved
parents in the distraction intervention (; Bellieni 2006; Blount
1992; Cavender 2004; Kleiber 2001; McCarthy 2010) whereas
others did not (Gupta 2006; Jeffs 2007; Kristjansdottir 2010;
Noguchi 2006; Tak 2006; Wang 2008). Future research should
consider the potential impact of parental involvement on intervention
delivery and efficacy, as parental presence alone is known
to influence children's behaviour during painful experiences regardless
of parent behaviour (see Vervoort 2008; Vervoort 2011).
Thus, although we can conclude overall that distraction is efficacious
for reducing needle-related pain, our ability to differentiate
which aspects of distraction are most efficacious remains limited.
Actual engagement of the parent or child, or both, in the distraction
activity should also be routinelymonitored in RCTs, as the effectiveness
of a particular distractor may depend on the level of engagement
or dose received. McCarthy and colleagues (McCarthy
2010) noted that some parents in their control group engaged
naturally in distraction. In order to best identify the impact of
distraction on needle-related pain and distress, they created three
comparison groups based on the actual level of observed parent
distraction during the intravenous line (IV) insertion, regardless of
experimental group. This secondary analysis provided a more rigorous
test of the impact that distraction had on child pain. While
child engagement and successful use of distraction techniques are
critical for making conclusions about efficacy, very few studies
routinely assess and control for this important confounder.
Importantly, the age range of children included in the trials in this
review varied greatly, making it difficult to determine which psychological
interventions are most effective for different age ranges
or developmental periods. Furthermore, fewstudies exclusively examined
interventions in adolescents.Given the rapid developmental
changes that take place fromearly childhood to late adolescence,
it is likely that the efficacy of interventions vary based on developmental
stage and maturity of the individual child. Indeed, self-
management of needle-related pain and distress using evidencebased
psychological interventions may be particularly important
for older children and adolescents when immunizations are often
given in school settings; reliance on parents decreases throughout
development and the children increasingly rely on cognitive coping
strategies. For example, children's inclination towards the use
of particular coping strategies changes across development, with
research indicating that younger children tend to use more behavioural
strategies, whereas older children and adolescents use
more cognitive strategies (Skinner 2007). Future research should
assess the relative efficacy of psychological interventions across development
in order to inform treatment that matches and bolsters
their effectiveness.
There was notable variability in the types of needle procedures
represented in this review, including those that are expected to
occur multiple times even among healthy children, such as immunizations.
However, very few trials assessed the efficacy of psychological
interventions over time and the maintenance of treatment
gains.One notable exception was thework of Liossi and colleagues
(Liossi 2009), who examined children's use of hypnosis over the
course of three needle-related procedures. In addition to examining
change over time, the researchers examined pain and distress
among children while they received therapist-guided hypnosis at
an initial procedure and then again while they engaged in self-hypnosis
during two subsequent procedures. This study highlights the
importance of examining changes and maintenance of treatment
gains within children over time, as well as the generalizability of
interventions beyond individual providers.
Lastly, in addition to direct outcomes such as quantifications of
pain and distress, it is also important to consider other relevant
but indirect evidence. For example, it would be helpful for studies
to assess child, caregiver, and health professional preference or
beliefs about different intervention techniques, changes over time
in the adoption of pain reduction and prevention strategies, data
on needle pain prevention and relief in adult or animal studies,
and expert opinions. Currently the Canadian Task on Preventative
Care classifies the opinions of respected authorities based on
clinical experience as level III (lowest rating) in terms of criteria for
evaluating evidence, while evidence from RCTs is rated as level I
(the highest rating) (Palda 2004). Additional evidence-based clinical
practice guidelines for reducing childhood vaccination pain are
also available and should be considered when conducting future
studies in the area of acute pain (Taddio 2010).
Quality of the evidence
To our knowledge, this reviewrepresents the largest andmost up to
date review of psychological interventions for needle-related pain
and distress in children and adolescents, and includes a total of 39
RCTs comprising 3394 participants. The evidence supporting the
efficacy of distraction and hypnosis for reducing children's pain
and distress is consistent across relevant included trials. Although
the quality of evidence is limited by the many studies with high or
unclear risk of bias for their outcomes, the 39 RCTs included in
this review can be considered the most rigorous and well-reported
studies in the field. An additional 128 studies were excluded due
to insufficient rigour or inadequate reporting of findings formetaanalysis.
Assessment of risk of bias in trial design and reporting is critical as
RCTs with unclear or high risk of bias have been associated with
significantly larger treatment effects in RCTs with children and
adults (Hartling 2009; Savovic 2012). Addressing incomplete outcome
data was the domain with the greatest proportion of studies
categorized as low risk of bias, although all trials showed the majority
of bias domains as high or unclear risk. In particular, high
risk of bias was most commonly found for blinding of participants
and personnel, and blinding of outcome assessment. While there
are few studies of psychological interventions where it is possible
to blind study participants and personnel to the treatment condition,
two of the included studies in this review (Goodenough
1997; McCarthy 2010) successfully blinded the observation coding
of outcomes. Thus, while complete blinding of the patient
or treatment administrator may not be feasible, we argue that researchers
should use blind outcome coding whenever possible to
reduce study bias, and that this can sometimes be achieved through
careful study design.
Many trials had unclear risk of bias, particularly in the domains
of random sequence generation, allocation concealment, and selective
reporting. While this may expose real limitations in study
design, it may alternatively reflect insufficient reporting of study
methods and procedures in published manuscripts. However, exaggerated
treatment effects have been shown in trials with inadequate
or unclear random sequence generation, allocation concealment,
or selective reporting (Chan 2004; Savovic 2012). This
suggests that researchers should pay careful attention to these domains
in study design and publication. Reporting of adequate sequence
generation is the only risk of bias domain with notable
improvement over the past 30 years of published RCTs in this
area. Researchers should carefully follow the CONSORT guidelines
(Moher 2001) when reporting randomized trials to ensure
that details relevant to randomization, allocation, and blinding are
adequately addressed.
Over half of the included trials had a high risk of other sources
of bias. Potential sources of bias captured in this domain included
concerns regarding the validity or reliability of measurement tools
used to assess the outcomes of pain and distress as well as how and
when outcomes were assessed (for example, using an unvalidated
modification of a validated pain assessment tool). Other notable
sources of potential bias included potential contamination of the
control or experimental group (for example, venepunctures occurring
in a group context and potential for distress contagion), baseline
differences between groups, and small sample size resulting in
the trial being underpowered to detect group differences. It is perhaps
surprising that these issues continue to be quite common as
their potential to lead to inaccurate estimates of treatment effects
has been noted for many years (Moher 1994).
Potential biases in the review process
Strengths of this review include the comprehensive and updated
literature searches, the inclusion of non-English publications, and
contacting authors when relevant data were missing from published
reports.Despite these efforts, 21 studieswere excluded solely
because they did not provide sufficient data in published reports
or via e-mail correspondence to allow for data pooling in themetaanalysis.
This represents a source of bias as it resulted in a large
number of RCTs that could not be adequately captured in our
review. In order to limit the exclusion of trials, we included RCTs
that provided full data for at least one outcome measure. However,
this may pose an additional source of bias given that significant
findings are sometimes more fully reported than non-significant
findings. To minimize this, authors should include summary
statistics (that is, means, SDs, cell sizes) for all assessed outcomes,
regardless of study results. In keeping with other recently
published Cochrane reviews and updates (for example, Eccleston
2012; Williams 2012a), we excluded unpublished dissertation
studies. This may introduce bias by excluding some relevant studies
and we recommend that dissertation authors submit their research
to scientific journals to make their findings more accessible
and ultimately help translate their research into practice.
Lastly, the timing of assessed pain and distress often varied across
studies, sometimes assessed during the needle procedure while in
other instances assessed at varying times post-procedure. In some
cases, the timing of assessed pain and distress was not clearly reported.
This variability in outcome assessments adds potential bias
in comparisons across studies. We recommend the standard assessment
of post-needle pain or distress immediately following the
procedure (that is, as soon as the needle is removed). If studies wish
to include additional post-needle measures, it would be helpful to
consider establishing a maximum time gap between completion
of the needle procedure and measurement of the outcome in order
to reduce possible memory-based biases (Noel 2012).
Agreements and disagreements with other
studies or reviews
To our knowledge, this is themost comprehensive updated review
of this topic. However, other systematic reviews in related areas are
available, which also support the efficacy of various psychological
or non-pharmacological interventions for pediatric pain management.
These include, and are not limited to, systematic reviews of
psychological interventions for reducing the pain and distress of
childhood immunizations (Chambers 2009), non-pharmacological
interventions for infant procedural pain (Pillai-Riddell 2011a;
Pillai-Riddell 2011b), music interventions for acute and chronic
pain in children and adults (Cepeda 2010; Klassen 2008), psychological
interventions for chronic or recurrent pain in children
and adolescents (Eccleston 2009), and psychological therapies for
sickle cell disease and pain (Anie 2012).
A U T H O R S ' C O N C L U S I O N S
Implications for practice
The results of this reviewsuggest that youth, caregivers, and healthcare
practitioners should use distraction techniques or hypnosis
during needle procedures.Despite the significant variability in distraction
interventions (for example, type of distractor, passive or
active involvement of the child, and parent or nurse involvement),
support is consistent for its efficacy in reducing pain from needlerelated
procedures. The most evidence is available for more common
needle procedures (for example, venepuncture, immunization)
and with children 12 years and younger, although support
also exists for its use with adolescents. Hypnosis can be particularly
helpful for more invasive needle procedures (for example,
lumbar punctures) and for reducing both pain and distress; however,
its application may be limited in practice given the reduced
availability of health professionals trained in hypnosis. In addition
to their efficacy in reducing pain and distress, these psychological
interventions can also help empower children, adolescents, and
their parents in being active agents in their own painmanagement,
thereby facilitating generalizability across settings and time.
At present there is no evidence for the efficacy of any other psychological
intervention, including preparation and information,
combined CBT, parent coaching plus distraction, suggestion, or
virtual reality, although more trials are needed. No conclusions
could be made about additional interventions, such as memory
alteration, parent positioning plus distraction, blowing out air, or
distraction plus suggestion, as only one study examined each of
these interventions. Of these interventions, it is likely that those
including distraction would bemost helpful (that is, parent coaching
plus distraction, parent positioning plus distraction, and distraction
plus suggestion).
Implications for research
(1) Types of interventions
It is our position that additional RCTs examining the effectiveness
of distraction to a no-treatment or standard care control have
limited value. Given the variety of distraction interventions described
in the included studies, further research on distraction
should compare different types of distractors (for example, active
versus passive) and assess the developmental appropriateness of
interventions, engagement and dose of the intervention, the impact
of novelty, or distractor preference and selection. Despite the
myriad of trials examining distraction, this review also identified
a variety of psychological interventions that have been examined
in only one or two RCTs to date. Several of these suggest promise
(for example, preparation and information, blowing out air, distraction
plus suggestion) with significant reductions in pain or
distress, or both, in single trials; however, conclusions about their
efficacy cannot be made at this time given the limited evidence
available.
(2) Consideration of child age and development
There is a gap in our understanding of the efficacy of interventions
across age ranges. Future trials should investigate potential age and
developmental differences, following the standard age ranges provided
by the Standards for Research (StaR) in ChildHealth initiative
(toddlers and preschoolers two to four years, grade-schoolers
five to 12 years, adolescents 13 to 19 years (Williams 2012b)).
Furthermore, given the limited evidence specific to adolescents,
it is critical for future trials to target that population given that
children's coping preferences change across development (Skinner
2007) as does parental involvement, and needle procedures such
as immunizations may occur in a variety of settings (for example,
school-based immunization clinics (Kristjansdottir 2010)).
(3) Consideration of variability in needle procedures
Future trials should address our limited understanding regarding
the efficacy of interventions for different needle procedures, particularly
those that are more routine (for example, immunization,
venepuncture) versus those that are considered more invasive (for
example, lumbar puncture, bone marrow aspiration), as well as
single event versus repeated or multiple needle procedures. In addition,
it will be important to assess pain and distress scores at different
stages of the procedure (for example, pre-procedure, during
procedure, post-procedure, and at subsequent future procedures)
to assess longer-term outcomes and to determine whether additional
practice and exposure to psychological interventions lead to
more optimal pain management.
(4) Improving trial quality and reporting
Although our research suggests that study quality and reporting
have improved over time (Uman 2010), there remains substantial
room for improvement as evidenced by the risk of bias scores reported
in this review. Specifically, researchers should ensure true
randomization procedures (for example, computer-generated random
numbers) and concealment of random allocation, optimize
blinding of study outcomes to the extent that is possible (for example,
blind coders coding from videotapes), and ensuring adequate
sample size for sufficient power to detect group differences.
These details should be clearly reported in publications, in addition
to thorough reporting of all outcomes and reasons for any
withdrawals and dropouts. When selecting outcome measures, researchers
should draw from efforts to standardize the use of the
highest quality assessment tools, such as the Initiative onMethods,
Measurement, and Pain Assessment in Clinical Trials (PedIMMPACT)
(McGrath 2008).
A C K N OWL E D G E M E N T S
We wish to thank themany individuals who helped in the preparation
of this updated review as well as the original review. First, we
would like to thank all members of the Cochrane Pain, Palliative,
and Supportive Care (PaPaS) team, particularly Anna Hobson,
Jessica Thomas, Frances Fairman, PhilWiffen, Yvonne Roy, Sylvia
Bickley, Jane Hayes, and Chris Eccleston. We would also like to
thank reference librarians PamParker,Tim Ruggles, Robin Parker,
and Susan Klawansky for their invaluable assistance. We are also
grateful to the advice and input of many others including: Kirk
Magee, Stephen Morley, G Allen Finley, and Paula Forgeron. We
sincerely thank all current and past members of the IWK Centre
for Pediatric Pain Research who helped with this project including
LeahWofsy, AimeeDort, KellyHayton, CrystalHolly, Jessica Ferguson,
Sarah Peddle, and Darby Eakins.We are especially grateful
to Javad Shahidi, Carl von Baeyer, Mirko Manchia, and Narjes
Sadr Momtaz who screened non-English studies for us and, when
necessary, conducted data extraction and risk of bias coding.
We would also like to thank the Dalhousie Cochrane Group and
Pain in Child Health (PICH), a strategic training initiative of the
Canadian Institutes ofHealth Research (CIHR), for their financial
support. This review update would not have been possible without
a Category A Grant from the IWK Health Centre awarded
to LS Uman. Funding was also provided by an IWK Establishment
Award to CT Chambers. CT Chambers and PJMcGrath are
supported by Canada Research Chairs. LS Uman received financial
support from the Natural Sciences and Engineering Council
of Canada (NSERC), the Nova Scotia Health Research Foundation
(NSHRF), and the Fonds de Reserche en Sante de Quebec
(FRSQ; Quebec Health Research Foundation) while conducting
the original review on which this update is based. Lastly, we wish
to thank themany study authors whose studies contributed to this
review, and who responded to our requests for additional data.
R E F E R E N C E S
References to studies included in this review
Balan 2009 {published data only}
Balan R, Bavdekar SB, Jadhav S. Can Indian classical
instrumental music reduce pain felt during venepuncture?.
Indian Journal of Pediatrics 2009;76:46973.
Bellieni 2006 {published data only}
Bellieni CV, Cordelli DM, Raffaelli M, Ricci B, Morgese
G, Buonocore G. Analgesic effect of watching TV during
venipuncture. Archives of Disease in Childhood 2006;91:
10157.
Bisignano 2006 {published data only}
Bisignano A, Bush JP. Distress in pediatric hematologyoncology
patients undergoing intravenous procedures:
Evaluation of a CD-ROM intervention. Children's Health
Care 2006;35(1):6174.
Blount 1992 {published data only}
Blount RL, Bachanas PJ, Powers SW, Cotter MC, Franklin
A, Chaplin W, et al.Training children to cope and parents
to coach them during routine immunizations: Effects on
child, parent, and staff behaviors. Behavior Therapy 1992;
23:689705.
Caprilli 2007 {published data only}
Caprilli S, Anastasi F, Grotto RP, Scollo M, Messeri A.
Interactive music as a treatment for pain and stress in
children during venipuncture: A randomized prospective
study. Journal of Developmental and Behavioral Pediatrics
2007;28:399403.
Cassidy 2002 {published data only}
Cassidy K-R, Reid GJ, McGrath PJ, Finley GA, Smith
DJ, Morley C, et al.Watch needle, watch TV: Audiovisual
distraction in preschool immunization. American Academy
of Pain Medicine 2002;3(2):10818.
Cavender 2004 {published data only}
Cavender K, Goff MD, Hollon EC, Guzzetta CE. Parent's
positioning and distracting children during venipuncture.
Journal of Holistic Nursing 2004;22(1):3256.
Chen 1999 {published data only}
Chen E, Zeltzer LK, Craske MG, Katz ER. Alteration
of memory in the reduction of children's distress during
repeated aversive medical procedures. Journal of Consulting
and Clinical Psychology 1999;67(4):48190.
Eland 1981 {published data only}
Eland JM.Minimizing pain associated with prekindergarten
intramuscular injections. Issues in Comprehensive Pediatric
Nursing 1981;5(5-6):36172.
Fanurik 2000 {published data only}
Fanurik D, Koh JL, Schmitz ML. Distraction techniques
combined with EMLA: Effects of IV insertion pain and
distress in children. Children's Health Care 2000;29(2):
87101.
Fowler-Kerry 1987 {published data only}
Fowler-Kerry S, Lander JR. Management of injection pain
in children. Pain 1987;30(2):16975.
Gold 2006 {published data only}
Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo A.
Effectiveness of virtual reality for pediatric pain distraction
during IV placement. Cyberpsychology and Behavior 2006;9
(2):20712.
Gonzalez 1993 {published data only}
Gonzalez JC, Routh DK. Effects of maternal distraction
versus reassurance on children's reactions to injections.
Journal of Pediatric Psychology 1993;18(5):593604.
Goodenough 1997 {published data only}
Goodenough B, Kampel L, Champion GD, Laubreaux
L, Nicholas MK, Ziegler JB, et al.An investigation of the
placebo effect and age-related factors in the report of needle
pain from venipuncture in children. Pain 1997;72:38391.
Gupta 2006 {published data only}
Gupta D, Agarwal A, Dhiraaj S, Tandon M, Kumar M,
Singh RS, et al.An evaluation of efficacy of balloon inflation
on venous cannulation pain in children: A prospective,
randomized, controlled study. Anesthesia and Analgesia
2006;102:13725.
Harrison 1991 {published data only}
Harrison A. Preparing children for venous blood sampling.
Pain 1991;45(3):299306.
Huet 2011 {published data only}
Huet A, Lucas-Polomeni MM, Robert JC, Sixou JL.
Hypnosis and dental anesthesia in children: A prospective
controlled study. International Journal of Clinical and
Experimental Hypnosis 2011;59:42440.
Inal 2012 {published data only}
Inal S, Kelleci M. Distracting children during blood draw:
Looking through distraction cards is effective in pain relief
of children during blood draw. International Journal of
Nursing Practice 2012;18:2109.
Jeffs 2007 {published data only}
Jeffs DA. A pilot study of distraction for adolescents during
allergy testing. Journal for Specialists in Pediatric Nursing
2007;12(3):17085.
Katz 1987 {published data only}
Katz ER, Kellerman J, Ellenberg L. Hypnosis in the
reduction of acute pain and distress in children with cancer.
Journal of Pediatric Psychology 1987;12(3):37994.
Kleiber 2001 {published data only}
Kleiber C, Craft-Rosenberg M, Harper DC. Parents as
distraction coaches during IV insertion: A randomized
study. Journal of Pain and Symptom Management 2001;22
(4):85161.
Kristjansdottir 2010 {published data only}
Kristjansdottir O, Kristjansdottir G. Randomized clinical
trial of musical distraction with and without headphones
for adolescents' immunization pain. Scandinavian Journal
of Caring Sciences 2011;25:1926.
Kuttner 1987 {published data only}
Kuttner L. Favorite stories: A hypnotic pain-reduction
technique for children in acute pain. American Journal of
Clinical Hypnosis 1988;30(4):28995.
Liossi 1999 {published data only}
Liossi C, Hatira P. Clinical hypnosis versus cognitive
behavioral training for pain management with pediatric
cancer patients undergoing bone marrow aspirations. The
International Journal of Clinical and Experimental Hypnosis
1999;47(2):10416.
Liossi C, Hatira P. Clinical hypnosis in the alleviation of
procedure-related pain in pediatric oncology patients. The
International Journal of Clinical and Experimental Hypnosis
2003;51(1):428.
Liossi C, White P, Hatira P. Randomized clinical trial of
local anesthetic versus a combination of local anesthetic with
self-hypnosis in the management of pediatric procedurerelated
pain. Health Psychology 2006;25:30715.
Liossi C, White P, Hatira P. A randomized clinical trial of a
brief hypnosis intervention to control venepuncture-related
pain of paediatric cancer patients. Pain 2009;142:25563.
McCarthy 2010 {published data only}
McCarthy AM, Hanrahan K, Zimmerman MB, Westhus
N, Allen S. Impact of parent-provided distraction on child
responses to an IV insertion. Children's Health Care 2010;
39:12541.
Nguyen 2010 {published data only}
Nguyen TN, Nilsson S, Hellstrom A-L, Bengtson A. Music
therapy to reduce pain and anxiety in children with cancer
undergoing lumbar puncture: A randomized clinical trial.
Journal of Pediatric Oncology Nursing 2010;27(3):14655.
Noguchi 2006 {published data only}
Noguchi LK. The effect of music versus nonmusic on
behavioral signs of distress and self-report of pain in
pediatric injection patients. Journal of Music Therapy 2006;
43(1):1638.
Press 2003 {published data only}
Press J, Gidron Y, Maimon M, Gonen A, Goldman V,
Buskila D. Effects of active distraction on pain of children
undergoing venipuncture: Who benefits from it?. The Pain
Clinic 2003;15(3):2619.
Sinha 2006 {published data only}
Sinha M, Christopher NC, Fenn R, Reeves L. Evaluation
of nonpharmacologic methods of pain and anxiety
management for laceration repair in the pediatric emergency
department. Pediatrics 2006;117:11628.
Tak 2006 {published data only}
Tak JH, van Bon WHJ. Pain- and distress-reducing
interventions for venepuncture in children. Child: Care,
Health, and Development 2006;32(3):25768.
Tyc 1997 {published data only}
Tyc VL, Leigh L, Mulhern RK, Kumar Srivastava D, Bruce
D. Evaluation of a cognitive-behavioral intervention for
reducing distress in pediatric cancer patients undergoing
magnetic resonance imaging procedures. International
Journal of Rehabilitation and Health 1997;3(4):26779.
Vessey 1994 {published data only}
Vessey JA, Carlson KL, McGill J. Use of distraction with
children during an acute pain experience. Nursing Research
1994;43(6):36972.
Vosoghi 2010 {published data only}
Vosoghi N, Chehrzad M, Abotalebi G, Atrkar RZ. Effects
of distraction on physiologic Indices and pain intensity in
children aged 3-6. HAYAT 2010;16(3-4):3947.
Wang 2008 {published data only}
Wang ZX, Sun LH, Chen AP. The efficacy of nonpharmacological
methods of pain management in school age
children receiving venepuncture in a paediatric department:
a randomized controlled trial of audiovisual distraction and
routine psychological intervention. Swiss Medical Weekly
2008;138(39-40):57984.
Windich-Biermeier 2007 {published data only}
Windich-Biermeier A, Sjoberg I, Dale JC, Eshelman D,
Guzzetta CE. Effects of distraction on pain, fear, and distress
during venous port access and venipuncture in children
and adolescents with cancer. Journal of Pediatric Oncology
Nursing 2007;24(1):819.
Wint 2002 {published data only}
Sander Wint S, Eshelman D, Steele J, Guzzetta CE. Effects
of distraction using virtual reality glasses during lumbar
punctures in adolescents with cancer. ONF 2002;29(1):
E815.
References to studies excluded from this review
Agarwal 2008 {published data only}
Agarwal A, Yadav G, Gupta D, Tandon M, Singh
PK, Singh U. The role of a flash of light for attenuation
of venous cannulation pain: a prospective, randomized,
placebo-controlled study. Anesthesia and Analgesia 2008;
106(3):8146.
Alavi 2005 {published data only}
Alavi A, Zargham A, Abdyzdan Z, Nmnbati M. The
comparison of distraction and EMLA cream effects on pain
intensity due to intravenous catheters in 5-12 years old
thalassemic children. Journal of Shahrekord University of
Medical Sciences 2005;7(3):915.
Alderfer 2010 {published data only}
Phipps S, Barrera M, Vannatta K, Xiong X, Doyle
JJ, Alderfer MA. Complementary therapies for children
undergoing stem cell transplantation: report of a multisite
trial. Cancer 2010;116(16):392433.
Alhani 2010 {published data only}
Alhani F. The effect of programmed distraction on the pain
caused by venipuncture among adolescents on hemodialysis.
Pain Management Nursing 2010;11(2):8591.
Anghelescu 2013 {published data only}
Anghelescu DL, Burgoyne LL, Faughnan LG, Hankins
GM, Smeltzer MP, Pui C. Prospective randomized crossover
evaluation of three anthesthetic regimens for painful
procedures in children with cancer. The Journal of Pediatrics
2013;162(1):13741.
Anson 2010 {published data only}
Anson L, Edmundson E, Teasley S. Implications of
evidence-based venipuncture practice in a pediatric health
care magnet facility. Journal of Continuing Education in
Nursing 2010;41(4):17985.
Arts 1994 {published data only}
Arts SE, Abu-Saad HH, Champion GD, Crawford
MR, Fisher RJ, Juniper KH, et al.Age-related response
to lidocaine-prilocaine (EMLA) emulsion and effect of
music distraction on the pain of intravenous cannulation.
Pediatrics 1994;93:797801.
Ashkenzai 2006 {published data only}
Ashkenazi M, Blumer S, Eli I. Effectiveness of various
modes of computerized delivery of local anesthesia in
primary maxillary molars. Pediatric Dentistry 2006;28(1):
2939.
Atkinson 2009 {published data only}
Atkinson P, Chesters A, Heinz P. Pain management and
sedation for children in the emergency department. BMJ
2009;339:b4234.
Bagnasco 2012 {published data only}
Bagnasco A, Pezzi E, Rosa F, Fornoni L, Sasso L. Distraction
techniques in children during venipuncture: an Italian
experience. Journal of Preventive Medicine and Hygiene
2012;53:448.
Baxter 2011 {published data only}
Baxter AL, Cohen LL, McElvery HL, Lawson ML, von
Baeyer CL. An integration of vibration and cold relieves
venipuncture pain in a pediatric emergency department.
Pediatric Emergency Care 2011;27(12):11516.
Bengston 2002 {unpublished data only}
Bengston BS, Jacobson RM, Friedrich WM, Vierkant RA,
Poland GA. Teaching self-hypnosis to alleviate vaccinationrelated
distress in children: A randomized, single-blinded
controlled trial. In preparation.
Berberich 2009 {published data only}
Berberich FR, Landman Z. Reducing immunization
discomfort in 4- to 6-year-old children: A randomized
clinical trial. Pediatrics 2009;124:e2039.
Boivin 2008 {published data only}
Boivin JM, Poupon-Lemarquis L, Iraqi W, Fay R,
Schmitt C, Rossignol P. A multifactorial strategy of pain
management is associated with less pain in scheduled
vaccination of children. A study realized by family
practitioners in 239 children aged 4-12 years old. Family
Practice 2008;25(6):4239.
Bowen 1999 {published data only}
Bowen AM, Dammeyer MM. Reducing children's
immunization distress in a primary care setting. Journal of
Pediatric Nursing 1999;14:296303.
Broome 1998 {published data only}
Broome ME, Rehwaldt M, Fogg L. Relationships between
cognitive behavioral techniques, temperament, observed
distress, and pain reports in children and adolescents during
lumbar puncture. Journal of Pediatric Nursing 1998;13(1):
4854.
Bruck 1995 {published data only}
BruckM, Ceci SJ, Francoeur E, Barr R. I hardly cried when
I got my shot! Influencing children's reports about a visit
to their pediatrician. Child Development 1995;66:193208.
Bufalini 2009 {published data only}
Bufalini A. Role of interactive music in oncological pediatric
patients undergoing painful procedures [Ruolo della musica
interattiva nel paziente pediatrico oncologico sottoposto
a procedure dolorose]. Minerva Pediatrica 2009;61(4):
37990.
Bufalini 2012 {unpublished data only}
Bufalini A. The effect of live music on oncological paediatric
patients during painful procedures. European Journal of
Integrative Medicine 2012.
Carlson 2000 {published data only}
Carlson KL, Broome M, Vessey JA. Using distraction to
reduce reported pain, fear, behavioral distress in children
and adolescents: A multisite study. Journal of the Society of
Pediatric Nurses 2000;5:7585.
Chen 2000b {published data only}
Chen E, Craske MG, Katz ER, Schwartz E, Zeltzer LK.
Pain-sensitive temperament: Does it predict procedural
distress and response to psychological treatment among
children with cancer?. Journal of Pediatric Psychology 2000;
25(4):26978.
Christiano 1996 {unpublished data only}
Christiano BA. Children's coping and distress during
invasive dental procedures: The effects of matching coping
interventions to coping styles. Doctoral Dissertation. Case
Western Reserve University, 1996.
Cline 2006 {published data only}
Cline RJ, Harper FW, Penner LA, Peterson AM, Taub
JW, Albrecht TL. Parent communication and child pain
and distress during painful pediatric cancer treatments.
Social Science & Medicine 2006;63(4):88398.
Cohen 1997 {published data only}
Cohen LL, Blount RL, Panopoulos G. Nurse coaching
and cartoon distraction: An effective and practical
intervention to reduce child, parent, and nurse distress
during immunizations. Journal of Pediatric Psychology 1997;
22(3):35570.
Cohen LL, Blount RL, Jansevics Cohen R, Schaen
ER, Zaff JF. Comparative study of distraction versus
topical anesthesia for pediatric pain management during
immunizations. Health Psychology 1999;18(6):5918.
Cohen LL, Blount RL, Jansevics Cohen R, Ball CM,
McClellan CB, Bernard RS. Children's expectations and
memories of acute distress: Short- and long-term efficacy
of pain management interventions. Journal of Pediatric
Psychology 2001;26(6):36774.
Cohen LL, Bernard RS, Greco LA, McClellan CB. A childfocused
intervention for coping with procedural pain: Are
parent and nurse coaches necessary?. Journal of Pediatric
Psychology 2002;27(8):74957.
Cohen L. A multifaceted distraction intervention may
reduce pain and discomfort in children 4-6 years of age
receiving immunisation. Evidence Based Nursing 2010;13:
156.
Cramer-Berness 2005 {published data only}
Cramer-Berness LJ, Friedman AG. Behavioral Interventions
for Infant Immunizations. Children's Health Care 2005;34
(2):95111.
Crowley 2011 {published data only}
Crowley MA, Storer A, Heaton K, Naccarato MK,
Proehl JA, Moretz JD, Li S. Emergency nursing resource:
needle-related procedural pain in pediatric patients in the
emergency department. Journal of Emergency Nursing 2011;
37(3):24651.
Dalhquist 2002 {published data only}
Dahlquist LM, Pendley JS, Landthrip DS, Jones CL,
Steuber CP. Distraction intervention for preschoolers
undergoing intramuscular injections and subcutaneous port
access. Health Psychology 2002;21(1):949.
Dalhquist 2005 {published data only}
Dahlquist LM, Shroff Pendley J. When distraction fails:
Parental anxiety and children's responses to distraction
during cancer procedures. Journal of Pediatric Psychology
2005;30(7):6238.
Davit 2011 {published data only}
Davit CJ, Hundley RJ, Bacic JD, Hanson EM. A pilot
study to improve venipuncture compliance in children and
adolescents with autism spectrum disorders. Journal of
Developmental and Behavioral Pediatrics 2011;32(7):5215.
Demir 2012 {published data only}
Demir G, Cukurova Z, Eren G, Tekdos Y, Hergunsel
O. The effect of Multiphase Sedation in the course of
computed tomography and magnetic resonance imaging on
children, parents and anesthesiologists. Revista Brasileira de
Anestesiologia 2012;62(4):5119.
Drahota 2008 {published data only}
Drahota A, Galloway E, Stores R, Ward D, Severs M,
Dean T. Audiovisual distraction as an adjunct to pain and
anxiety relief during minor surgery. Foot (Edinburgh) 2008;
18(4):2119.
Dufresne 2010 {published data only}
Dufresne A, Dugas MA, Samson Y, Barre P, Turcot L,
Marc I. Do children undergoing cancer procedures under
pharmacological sedation still report pain and anxiety? A
preliminary study. Pain Medicine 2010;11(2):21523.
El-Sharkawi 2012 {published data only}
El-Sharkawi HFA, El-Housseiny AA, Aly AM. Effectivness
of new distraction technique on pain associated with
injection of local anesthesia for children. Pediatric Dentistry
2012;34(2):1425.
Fassler 1985 {published data only}
Fassler D. The fear of needles in children. The American
Journal of Orthopsychiatry 1985;55(3):3717.
French 1994 {published data only}
French GM, Painter EC, Coury DL. Blowing away
shot pain: A technique for pain management during
immunization. Pediatrics 1994;93(3):3848.
Gilbert 1982 {published data only}
Gilbert BO, Bennett Johnson S, Spillar R, McCallum
M, Silverstein JH, Rosenbloom A. The effect of a peermodelling
film on children learning to self-inject insulin.
Behavior Therapy 1982;13:18693.
Goymour 2000 {published data only}
Goymour K, Stephenson C, Goodenough B, Boulton
C. Evaluating the role of play therapy in the pediatric
emergency department. AENJ 2000;3(2):102.
Hatava 2000 {published data only}
Hatava P, Olsson GL, Lagerkranser M. Preoperative
psychological preparation for children undergoing ENT
operations: a comparison of two methods. Paediatric
Anaesthesia 2000;10:47786.
Hawkins 1998 {published data only}
Hawkins PJ. Hypnosis in the alleviation of procedure
related pain and distress in paediatric oncology patients.
Contemporary Hypnosis 1998;15(4):199207.
Heckler-Medina 2006 {published data only}
Heckler-Medina GA. The importance of child life and pain
management during vascular access procedures in pediatrics.
Journal of the Association for Vascular Access 2006;11(3):
14451.
Heden 2009 {published data only}
Heden L, von Essen L, Ljungman G. Randomized
interventions for needle procedures in children with cancer.
European Journal of Cancer Care 2009;18(4):35863.
Hoffman 2011 {published data only}
Hoffmann F, Deanovic D. Prehospital pain management in
children and adolescents [Praklinische Schmerztherapie bei
Kindern und Jugendlichen]. Notfall and Rettungsmedizin
2011;14(7):54953.
Howe 2011 {published data only}
Howe CJ, Ratcliffe SJ, Tuttle A, Dougherty S, Lipman
TH. Needle anxiety in children with type 1 diabetes and
their mothers. MCN. The American Journal of Maternal
Child Nursing 2011;36(1):2531.
Inal 2010 {published data only}
Inal S, Kelleci M. External thermomechanical stimulation
and distraction are effective on pain relief of children
during blood draw. 14th International Nursing Research
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Jacobson 2006 {published data only}
Jacobson AF. Cognitive-behavioral interventions for IV
insertion pain. AORN J 2006;84(6):103148.
Jay 1987 {published data only}
Jay SM, Elliott CH, Katz E, Siegel SE. Cognitive-behavioral
and pharmacologic interventions for children's distress
during painful medical procedures. Journal of Consulting
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Jay SM, Elliott CH. A stress inoculation program for parents
whose children are undergoing painful medical procedures.
Journal of Consulting and Clinical Psychology 1990;58(6):
799804.
Jay SM, Elliott CH, Woody PD. An investigation of
cognitive-behavior therapy combined with oral Valium for
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general anesthesia for painful medical procedures in
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Kain 2006 {published data only}
Kain ZN, Caldwell-Andrews AA, Mayes LC, Weinberg
ME, Wang SM, MacLaren JE, Blount RL. Family-centered
preparation for surgery improves perioperative outcomes
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pediatric and geriatric medicine - pain measurement:
What pain scale in which patients? [Akutschmerztherapie
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Kazak 1996 {published data only}
Kazak AE, Penati B, Boyer BA, Himelstein B, Brophy
P, Waibel MK, et al.A randomized controlled perspective
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61531.
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Kazak AE, Penati B, Brophy P, Himelstein B. Pharmacologic
and psychologic interventions for procedural pain. Pediatrics
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Kettwich 2007 {published data only}
Kettwich SC, Sibbitt Jr WL, Brandt JR, Johnson
CR, Wong CS, Bankhurst AD. Needle phobia and
stress-reducing medical devices in pediatric and adult
chemotherapy patients. Journal of Pediatric Oncology
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Klingman A. Mass inoculation in a community: the effect
of primary prevention of stress reactions. American Journal
of Community Psychology 1985;13(3):32332.
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Effects of coping and mastery modelling on experienced and
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Kolk 2000 {published data only}
Kolk AM, van Hoof R, Fiedeldij Dop MJC. Preparing
children for venepuncture. The effect of an integrated
intervention on distress before and during venipuncture.
Child: Care, Health and Development 2000;26(3):25160.
Krauss 1996 {unpublished data only}
Krauss WJ. Videotape modelling and parent participation:
Effects on reducing distress behavior in children undergoing
immunization procedures. Doctoral Dissertation,
California School of Professional Psychology 1996.
Kuttner 1988 {published data only}
Kuttner L, Bowman M, Teasdale M. Psychological
treatment of distress, pain, and anxiety for young children
with cancer. Developmental and Behavioral Pediatrics 1988;
9(6):37481.
Kwekkeboom 2003 {unpublished data only}
Kwekkeboom KL. Music versus distraction for procedural
pain and anxiety in patients with cancer. ONF 2003;30(3):
43340.
Lawes 2008 {published data only}
Lawes C, Sawyer L, Amos S, Kandiah M, Pearce L,
Symons J. Impact of an education programme for staff
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Lessi 2011 {published data only}
Lessi E, Biasutto M, Ferrazzo M. The pain from
venipuncture in children: The benefit of visual distraction
[Il dolore da venipuntura nel bambino: Il beneficio della
distrazione con audiovisivi]. Gli Infermieri dei Bambini
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expectancy as a mediator between child expected and
experienced procedure-related pain intensity during painful
medical procedures. The Clinical Journal of Pain 2007;23
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Lustman 1983 {published data only}
Lustman NM. The effectiveness of two different
components of stress inoculation, preparatory information
and the teaching of coping devices aimed at mothers whose
children are undergoing minor surgery. Yale University
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MacLaren 2005 {published data only}
MacLaren JE, Cohen LL. A comparison of distraction
strategies for venipuncture distress in children. Journal of
Pediatric Psychology 2005;30(5):38796.
MacLaren 2007 {published data only}
MacLaren JE, Cohen LL. Interventions for paediatric
procedure-related pain in primary care. Paediatrics & Child
Health 2007;12(2):111-6.
Malone 1996 {published data only}
Malone AB. The effects of live music on the distress
of pediatric patients receiving intravenous starts,
venipunctures, injections, and heel sticks. Journal of Music
Therapy 1996;33(1):1933.
Manimala 2000 {published data only}
Manimala R, Blount RL, Cohen LL. The effects of parental
reassurance versus distraction on child distress and coping
during immunizations. Child Health Care 2000;29:16177.
Manne 1990 {published data only}
Manne SL, Redd WH, Jacobsen PB, Gorfinkle K, Schorr O.
Behavioral intervention to reduce child and parent distress
during venipuncture. Journal of Consulting and Clinical
Psychology 1990;58(5):56572.
Manne 1994 {published data only}
Manne SL, Bakerman R, Jacobsen PB, Gorfinkle K, Redd
WH. An analysis of a behavioral intervention for children
undergoing venipuncture. Health Psychology 1994;13(6):
55666.
Marec-Berard 2009 {published data only}
Marec-Berard P, Bissery A, Kebaili K, Schell M, Aubert F,
Gaillard S, et al.A positioning pillow to improve lumbar
puncture success rate in paediatric haematology-oncology
patients: a randomized controlled trial. BMC Cancer 2009;
21: doi:10.1186/14712407-9-21.
McCarthy 1998 {published data only}
McCarthy AM, Cool VA, Hanrahan K. Cognitive
behavioral interventions for children during painful
procedures: Research challenges and program development.
Journal of Pediatric Nursing 1998;13(1):5563.
McCarthy 2010b {published data only}
McCarthy AM, Kleiber C, Hanrahan K, Zimmerman
MB, Westhus N, Allen S. Factors explaining children's
responses to intravenous needle insertions. Nursing Research
2010;59(6):40716.
McInally 2005 {published data only}
McInally W. Whose line is it anyway? Management of
central venous catheters in children. Paediatric Nursing
2005;17(5):148.
Megel 1998 {published data only}
Megel ME, Houser CW, Gleaves LS. Children's responses
to immunizations: Lullabies as a distraction. Issues in
Comprehensive Pediatric Nursing 1998;21:12945.
Melamed 1974 {published data only}
Melamed BG, Hawes RR, Heiby E, Glick J. Use of filmed
modelling to reduce uncooperative behavior of children
during dental treatment. Journal of Dental Research 1974;
54(4):797801.
Myrvik 2009 {unpublished data only}
Myrvik MP. A behavioral intervention targeting a
reduction in child distress during a routine immunization.
Dissertation, University of North Dakota 2008.
Nilsson 2009 {published data only}
Nilsson S, Finnstrom B, Kokinsky E, Enskar K. The use
of Virtual Reality for needle-related procedural pain and
distress in children and adolescents in a paediatric oncology
unit. European Journal of Oncology Nursing 2009;13(2):
1029.
O'Laughlin 1995 {published data only}
O'Laughlin E, Ridley-Johnson. Maternal presence during
children's routine immunizations: The effect of mother as
observer in reducing child distress. Children's Health Care
1995;24(3):17591.
Olsen 1991 {published data only}
Olsen BR. Brief interventions for routine use with children
in a phlebotomy laboratory. West Virginia University
(Doctoral Dissertation) 1991.
Ozdemir 2012 {published data only}
Ozdemir FK, Tufekci FG. The effect of using musical
mobiles on reducing pain in infants during vaccination.
Journal of Research in Medical Sciences 2012;17(7):6627.
Park 2008 {published data only}
Park SH, Bang SM, Nam E, Cho EK, Shin DB,
Lee JH, Ahn JY. A randomized double-blind placebocontrolled
study of low-dose intravenous Lorazepam to
reduce procedural pain during bone marrow aspiration and
biopsy. Pain Medicine 2008;9(2):24952.
Pederson 1996 {published data only}
Pederson C. Promoting parental use of nonpharmacologic
techniques with children during lumbar punctures. Journal
of Pediatric Oncology Nursing 1996;13(1):2130.
Peretz 1999 {published data only}
Peretz B, Gluck GM. Assessing an active distracting
technique for local anesthetic injection in pediatric dental
patients: repeated deep breathing and blowing out air. The
Journal of Clinical Pediatric Dentistry 1999;24(1):58.
Posner 1998 {unpublished data only}
Posner K. A pharmacobehavioral intervention to reduce
child cancer distress. Ferkauf Graduate School of
Psychology, Doctoral Dissertation. Yeshiva University,
1998.
Powers 1993 {published data only}
Powers SW, Blount RL, Bachanas PJ, Cotter MW, Swan
SC. Helping preschool leukemia patients and their parents
cope during injections. Journal of Pediatric Psychology 1993;
18(6):68195.
Ramponi 2009 {published data only}
Ramponi D. Reducing pain in pediatric procedures in the
emergency department. Journal of Emergency Nursing 2009;
35(4):37982.
Reeb 1997 {published data only}
Reeb RN, Busch JP. Preprocedural psychological preparation
in pediatric oncology: A process-oriented intervention
study. Children's Health Care 1997;25:26579.
Rogovik 2007 {published data only}
Rogovik AL, Goldman RD. Hypnosis for treatment of pain
in children. Canadian Family Physician 2007;53(5):823-5.
Russell 2012 {unpublished data only}
Russell K, Nicholson R, Legge L, Leauanae E, Olsen A,
Marsh S, Naidu R. Reducing the pain of Bicillin injections
in the rheumatic fever population of CMDHB. Conference
presentation 2012.
Salih 2010 {published data only}
Salih N, Baumler PI, Simang M, Irnich D. Deqi sensations
without cutaneous sensory input: results of an RCT. BMC
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Santos 1999 {published data only}
Santos LMCN, Borba RIH, Sabates AL. The importance of
the preschool in the preparation for intramuscular injection
using the play [La importancia del preparo de ninos en edad
prescolar para la injeccion intramuscular con el uso del
juguete]. Acta Paulista de Enfermagem 2000;13(2):528.
Schechter 2010 {published data only}
Schechter NL, Bernstein BA, Zempsky WT, Bright NS,
Willard AK. Educational outreach to reduce immunization
pain in office settings. Pediatrics 2010;126(6):151421.
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Schneider SM, Kisby CK, Flint EP. Effect of virtual reality
on time perception in patients receiving chemotherapy.
Support Care in Cancer 2011;19(4):55564.
Schur 1986 {unpublished data only}
Schur JM. Alleviating behavioral distress with music or
lamaze pant-blow breathing in children undergoing bone
marrow aspirations and lumbar punctures. The University
of Texas Health Science Center at Dallas (Doctoral
Dissertation) 1986.
Shabanloei 2010 {published data only}
Shabanloei R, Golchin M, Esfahani A, Dolatkhah R,
Rasoulian M. Effects of music therapy on pain and anxiety
in patients undergoing bone marrow biopsy and aspiration.
AORN J 2010;91(6):74651.
Shahabi 2007 {published data only}
Shahabi M, Kalani-Tehrani D, Eghbal M, Alavi-Majd H,
Abed Saidi J. Comparing the effects of EMLA ointment
with a diversionary activity (music) on vein puncture pain
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2007;17:56.
Shimizu 2005 {published data only}
Shimizu T, Inomata S, Kihara S, Toyooka H, Brimacombe
JR. Rapid injection reduces pain on injection with propofol.
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Sikorova L, Hrazdilova P. The effect of psychological
intervention on perceived pain in children undergoing
venipuncture. BioBiomedical papers of the Medical Faculty of
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Slack D, Nelson L, Patterson D, Burns S, Hakimi
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ameliorating pain and anxiety among adults undergoing
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Slifer KJ, Demore M, Vona-Messersmith N, Pulbrook-
Vetter V, Beck M, Dalhquist L, et al. Comparison of two
brief parent-training interventions for child distress during
parent-administered needle procedures. Child Health Care
2009;38(1):2348.
Slifer 2011 {published data only}
Slifer KJ, Hankinson JC, Zettler MA, Frutchey RA,
Hendricks MC, Ward CM, Reesman J. Distraction,
exposure therapy, counterconditioning, and topical
anesthetic for acute pain management during needle sticks
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Smith 1989 {published data only}
Smith KE, Ackerson JD, Blotcky AD. Reducing distress
during invasive medical procedures: Relating behavioral
interventions to preferred coping style in pediatric cancer
patients. Journal of Pediatric Psychology 1989;14(3):40519.
Smith 1996 {published data only}
Smith JT, Barabasz A, Barabasz M. Comparison of hypnosis
and distraction in severely ill children undergoing painful
medical procedures. Journal of Counseling Psychology 1996;
43(2):18795.
Sparks 2001 {published data only}
Sparks L. Taking the ouch out of injections for children:
Using distraction to decrease pain. The American Journal of
Maternal/Child Nursing 2001;26(2):728.
Stefano 2005 {unpublished data only}
Stefano C, Giancarlo I, Corrado V. The experience of
control related to the procedure of non-pharmacologic
pain management in paediatric oncology and heamatology.
Poster abstract - no source identified. 2005.
Stevenson 2005 {published data only}
Stevenson MD, Bivins CM, O'Brien K, Gonzalez del Rey
JA. Child life intervention during angiocatheter insertion in
the pediatric emergency department. Pediatric Emergency
Care 2005;21(11):7128.
Sury 2010 {published data only}
Sury M, Bullock I, Rabar S, DeMott K. Sedation for
diagnostic and therapeutic procedures in children and
young people: summary of NICE guidance. BMJ 2010;
341:c6819.
Thurgate 2005 {published data only}
Thurgate C, Heppell S. Needle phobia--changing
venepuncture practice in ambulatory care. Paediatric
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Tufekci 2009 {published data only}
Tufekci FG, Celebio lu A, Kucuko lu S. Turkish children
loved distraction: using kaleidoscope to reduce perceived
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Vernon 1974 {published data only}
Vernon DTA. Modeling and birth order in responses to
painful stimuli. Journal of Personality and Social Psychology
1974;29(6):7949.
Vika 2009 {published data only}
Vika M, Skaret E, Raadal M, Ost LG, Kvale G. Onevs.
five-session treatment of intra-oral injection phobia: a
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Vohra S, Nilsson S. Does music therapy reduce pain
and anxiety in children with cancer undergoing lumbar
puncture?. Focus on Alternative and Complementary
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Wall VJ, Womack W. Hypnotic versus active cognitive
strategies for alleviation of procedural distress in pediatric
oncology patients. American Journal of Clinical Hypnosis
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Wallace DP, Allen KD, Lacroix AE, Pitner SL. The cough
trick: a brief strategy to manage pediatric pain from
immunization injections. Pediatrics 2010;125(2):e36773.
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Weber FS. The influence of playful activities on children's
anxiety during the preoperative period at the outpatient
surgical center. Jornal de Pediatria 2010;86(3):20914.
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Weinstein P, Raadal M, Naidu S, Yoshida T, Kvale G,
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Winborn 1989 {published data only}
Winborn MD. Associative and dissociative preparatory
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Young MR, Fu VR. Influence of play and temperament
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Zahr KL. Therapeutic play for hospitalized preschoolers in
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for reduction of pain and anxiety during painful procedures
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C H A R A C T E R I S T I C S O F S T U D I E S
Characteristics of included studies [ordered by study ID]
Balan 2009
Methods Allocation: randomized using a random number table
Participants Needle Procedure: venepuncture for blood collection
Inclusion:
-children aged 5-12 years requiring venepuncture for blood collection (Note: chi
ldren
over 7 enrolled only if provided assent)
Exclusion:
-children with a history of hypersensitivity to local anesthetics of the amide t
ype (lidocaine,
prilocaine, mepivicaine, bupivicaine, etidocaine) or to one or more constituents
of EMLA
-history of congenital or idiopathic methaemoglobinaemia, glucose-6-phosphatase
deficiency
or severe hepatic disease
-children with altered sensorium and this found to have hearing impairment on cl
inical
examination
-children whose clinical condition warranted urgent administration of drugs
N: 100
Age: 5-12 years
Gender: F=45, M=55
Diagnosis: heterogeneous. See exclusion criteria
Setting: Inpatient department at hospital, Mumbai
Interventions 1. Music Therapy (n = 50): Indian instrumental classical music (Ty
pe of music: Hindustani
classical music - instrumental - raaga) `Todi' was played with the walkman for
children belonging to the music group
2. Local Anaesthesia (LA) (n = 50): Similar procedure as the placebo group; howe
ver
EMLA cream (lidocaine 2.5% and prilocaine 2.5%) and not a placebo cream was used
for local application
3. No Intervention (Placebo) (n = 50): The placebo group was included in the stu
dy, as
`not using anything' (equivalent to placebo). Placebo cream (2.5g) consisting of 100
%
petroleum jelly was applied to the local body part with an occlusive dressing fo
r 45 min.
Earphones attached to a `Walkman' were applied to the child's ears for 15 min before
the procedure, through the procedure and for 5 minutes thereafter; however, no m
usic
was played
Outcomes Pain (all ratings at minute 0):
Self-report: VAS (0-10)
Caregiver/Parent: VAS
Nurse/Health Professionals: VAS (by investigator), VAS (by independent observer)
Notes We used a total N of 100 for this study (instead of 150) because we only a
ssessed 2/3
conditions (music therapy versus placebo group)
Risk of bias
Balan 2009 (Continued)
Bias Authors' judgement Support for judgement
Random sequence generation (selection
bias)
Low risk randomizedusing random number table
p.470 Par 1
Allocation concealment (selection bias) High risk Use of an open random allocati
on schedule
(e.g. random number table)
Incomplete outcome data (attrition bias)
All outcomes
Unclear risk Whenever possible this child was also told
to indicate his or her score on the VAS. p.
470 Par 2
Selective reporting (reporting bias) High risk One or more outcomes reported inc
ompletely
for inclusion in meta-analysis
Other bias Low risk Appears to be free of other bias that would
affect outcomes
Blinding of participants and personnel
(performance bias)
All outcomes
High risk Participants and personnel were not
blinded
Blinding of outcome assessment (detection
bias)
All outcomes
High risk No blinding of self-report outcome assessment
and researcher provided intervention
and outcome assessment
Bellieni 2006
Methods Allocation: using random numbers from a computer generated sequence
Participants Needle Procedure: venepuncture
Inclusion:
-7-12 years old
-last meal at least 3 h before venepuncture
Exclusion:
-no neurodevelopmental delay
-no frequent venepunctures (more than 1/year)
N: 69
Age: 7-12 years old
Gender: F=36, M=33
Diagnosis: outpatients
Setting: no detail provided, Italy
Interventions 1. Cartoon TV Distraction (n = 23): For the TV group, the children
were set in front of
a TV screen, at a distance of approximately 2.5 m; movies started at least 120 s
before
venepuncture. The children were invited to watch the cartoon when it started and
no
other distraction. Mothers were present in the blood sampling room, but were req
uested
to not do anything to distract the children during venepuncture
Bellieni 2006 (Continued)
2. Mother-Directed Distraction (n = 23): Mothers were asked to actively distract
their
children during the venepuncture by speaking, caressing, and soothing them
3. No Distraction Control (n = 23): Mothers were present in the blood sampling r
oom,
but were requested to not do anything to distract the children during venepunctu
re
Outcomes 1. OUCHER - child self-report
2. OUCHER - parent-report
Notes None
Risk of bias
bias)
Low risk using a randomnumbers froma computer
generated sequence p.1015 Par 2
Allocation concealment (selection bias) Unclear risk Insufficient information to
permit judgment
of 'low' or 'high' risk
All outcomes
Low risk No missing data
Selective reporting (reporting bias) Unclear risk Insufficient information to pe
rmit judgment
Other bias Unclear risk Insufficient information to assess whether
an important risk of bias exists (e.g. parenting
pain ratingignoring the score given
by the child p.1015)
(performance bias)
All outcomes
High risk Study participants and personnel were not
blinded
bias)
All outcomes
High risk No blinding of outcome assessment
Bisignano 2006
Methods Allocation: stratified randomization process was used, randomized accord
ing to gender's
TAQ scores (high, medium, low) - TAQ-threat appraisals
Participants Needle Procedure: IV Procedures
Inclusion:
-English-speaking 7-18 year olds scheduled for IV procedures at the paediatric h
aematology/
oncology clinic at a large urban medical centre
Bisignano 2006 (Continued)
-histories included at least two previous IVs
Exclusion:
-none given
N: 30
Age: 6-18 years (Mean = 11.4)
Gender: F=15, M=15
Diagnosis: cancer inpatients and outpatients at a paediatric haematology/oncolog
y clinic.
Also, sickle cell anaemia, lymphoma, leukaemia, osteosarcoma, etc
Setting: Haematology/Oncology clinic at large urban medical centre
Interventions 1. CD-ROMIntervention (n=14): CD Rom available free of charge from
Starlight Starbright
to children, families, and health professionals as part of the STARBRIGHT Explor
erSeries
(http://www.starlight.org). The CD-ROM was designed to help children
learn about the medical procedure. Children in the intervention condition had ap
proximately
20 min to interact with the CD-ROM. Spotlight on IVs is an interactive CDROM
that consists of four components: education/information, pre-procedural preparat
ion
(video modelling), breathing exercises, and distracting imagery. In the educatio
n/
information section, the CD-ROM allows children to ask questions such as What is
an IV? and How does an IV work? using an animated nurse character named Ima
Helpa. In addition, children are educated on IV procedural terms. During pre-pro
cedural
preparation, children are given a choice of viewing two videos on IV procedure.
The
first demonstrates a young girl being given an IV by a nurse, and the second use
s a young
boy to demonstrate how to get around with an IV attachment. In the breathing exe
rcises
section, the children are taught simple breathing exercises by Ima Helpa. Childr
en are
instructed to take a deep breath and to let it out slowly. For imagery, children
are taught a
simple imagery technique focusing on a calming location. This may serve two purp
oses,
distraction and relaxation. In addition to Spotlight on IVs, a secondCD-ROM, Spo
tlight
on IV Catheters, developed by the first author, was utilized. This CD-ROM focuse
d
on the particular IV procedures used with some of the children (i.e., Broviac, P
ort-acath),
because Spotlight on IVs does not provide images of these procedures. Haematolog
y-
oncology paediatric patients encounter various types of IVs, including Hickman,
Broviac, Port-a-cath, and PICC. Spotlight on IV Catheters contains information a
nd
images specific to all three kinds of IVs, whereas Spotlight on IVs only demonst
rates
PICCs. Like Spotlight on IVs, Spotlight on IV Catheters is colourful and appropr
iate
for children ages 7 to 18. Children in the treatment group viewed both CD-ROMs.
2. Standard Medical Care Condition (n=16): Children received the routine hospita
l
preparation for the IV procedure. This preparation included an explanation of th
e IV
procedure and explanation of the topical anesthetic cream (EMLA) approximately 1
hr
prior to the IV procedure
Outcomes 1. Children's Pain Self-Report (Pain-SR) - aka a pain thermometer, ranging
from 0-
100 - immediately after IV
2. Children's Fear Self-Report (Fear-SR) - single item faces scale. Administered 1
) after
intervention and before IV and 2) after IV (only interested in after IV)
3. VAS (administered by trained RA) - measuring overall anxiety during IV, range
1-5
4. Procedural Behavioral Rating Scale (PBRS) - 3 phases, 1) before 2) during pre
-numb
swab/anaesthetic 3) during procedure until needle is out (only interested in pha
se 3)
Notes None
Bisignano 2006 (Continued)
Risk of bias
bias)
Unclear risk Insufficient information to permit judgment
permit judgment
All outcomes
High risk No reason provided for missing data and
imbalance in missing data across groups
rmit judgment
Other bias High risk Multiple potential sources of bias related to
study design and other problems
(performance bias)
All outcomes
High risk Participants were not blinded
bias)
All outcomes
Blount 1992
Methods Allocation: Randomized - no further details
Participants Needle Procedure: Routine immunization
Inclusion:
-children attending a local county health department
Exclusion:
- none given
N: 60
Age: 3-7 years (M = 5 years, SD = 10 months)
Gender: M = 32, F= 28
Diagnosis: none
Setting: Local county health department
Interventions 1. Distraction + Coping Skills Training + use of a party blower as
an age appropriate
version of deep breathing (n = 30): Activities the children would engage in prio
r to the
procedures included coloring, playing with toys/puzzles, or interactive reading
of a book.
Coping skills training involved providing parents with a rationale for the train
ing and
instructing them to coach their child to blow a party blower immediately prior t
o and
during the injections. The use of these components was modelled for the parents
and
Blount 1992 (Continued)
children by assistants assuming the roles of nurse, child, and parent. The paren
t then
practised the coaching in a role-play with the assistant using a pretend needle,
and was
given feedback and praise. Children were allowed to play with the toys and blowe
rs, and
were encouraged to watch the training. One role-play was attempted with the chil
d. The
total training session took 10-12 minutes
2. No-Treatment Control (n = 30): Control condition parents were asked to provid
e
demographic information and rate their child's fear and how much they expected to
be
able to help their child during the medical procedures. Children were asked to p
rovide
ratings of their fear using a faces scale. The control subjects waited until cal
led for their
immunization, while the treatment subjects completed the demographic questionnai
re
and underwent the coping skills training prior to completing the other pre-injec
tion
inventories
Outcomes 1. Child-Adult Medical Procedure Interaction Scale (CAMPIS)
2. Observational Scale of Behavioral Distress (OSBD)
3. Behavioral Approach-Avoidance and Distress Scale (BAADS)
4. Parent ratings of child fear, pain, and distress using a 10 cm VAS
5. Child self-reports of fear and pain using a 5-faces scale
6. Nurse ratings of child distress
Notes None
Risk of bias
bias)
permit judgment
All outcomes
Selective reporting (reporting bias) High risk One or more outcomes of interest
are reported
incompletely
Other bias High risk Potential source of bias related to validity of
measurement tool with participant young
age
(performance bias)
All outcomes
blinded
bias)
All outcomes
Caprilli 2007
Methods Allocation: children were randomly assigned to one of two groups
Inclusion:
-only native-born, Italian speaking children
Exclusion:
-significant hearing or visual impairments
-cognitive disorders
-previous experience of hospitalization
N: 108
Age: 4-13
Gender= F=56, M=52
Diagnosis: unclear
Setting: Anna Meyer Pediatric Hospital, Florence, Italy
Interventions 1. Music Distraction (n = 54): Children received live music interv
ention before, during,
and after blood sampling. The same two musicians participated in the entire stud
y. One
of the two musicians met the child and the parent in the waiting room. He starte
d
playing, singing, and proposing sonorous objects to the child and the parents an
d invited
everybody to join the performance: the musician's aim was to create a relationship
with
the child and the parents. The musician then asked whether the child would be ha
ppy to
have himin the procedure room, and if the child agreed, hewent in and continued
playing
and singing while the procedure was going on. After the procedure was finished,
he went
back to the waiting room together with the child and the parent, always interact
ing and
playing music with them. The musician stayed with the child approximately 20 min
utes
2. Control (n = 54): Children in this group received standard medical care. The
doctor
and nurse who performed the procedure were the same for the control and the musi
c
groups, and they were instructed to maintain their normal modes of consolation a
nd/or
distraction
Outcomes Pain:
Self-Report:Wong Baker Faces Scale (higher = more pain)
Distress:
Behavioral report: Amended form of Observation Scale of Behavioral Distress (OBS
DA)
Phase 2=during needle, Phase 3=after needle
Notes Only used outcomes for phase 2 in analyses.
Risk of bias
bias)
permit judgment
Caprilli 2007 (Continued)
All outcomes
are reported
incompletely
Other bias High risk Had a potential source of bias related to the
specific study design (e.g. timing of parent
ratings)
(performance bias)
All outcomes
blinded
bias)
All outcomes
Cassidy 2002
Methods Allocation: Randomized using a standard randomization table for each clu
ster of 10
subjects
Participants Needle Procedure: DPTP immunization
Inclusion:
- 5 years old
- due to receive standard DPTP preschool immunization
- in good health
- developmentally normal (i.e. the absence of developmental delays, in the exper
t opinion
of the attending paediatrician)
- subject's parent/guardian agreement to participate after initial recruitment con
tact
Exclusion:
- previously immunized with the preschool DPTP vaccine
- previously hospitalized
- the presence of any acute or chronic medical condition
N: 62
Age: all 5 years old
Gender: M = 28, F = 34
Diagnosis: none
Setting: two urban paediatric practices in Halifax, Nova Scotia, Canada
Interventions 1. Audio-Visual (AV) Distraction Using an Age-Appropriate TV Music
al Cartoon (n =
29): For both the distraction and control group, once in the examining room, the
child
sat on the examining table and faced a 30 x 36 cm TV screen at eye level approxi
mately
2 m away from the examining table. A video recorder was placed above the televis
ion,
and the research stood behind the AV equipment to operate the video camera. The
research greeted the child and asked him/her to watch the TV screen. The parent
was
asked to stand to the child's right side, hold his/her right hand, and not to talk
during
Cassidy 2002 (Continued)
the intervention. For the distraction group, the cartoon was turned on by the re
searcher
after the clinician approached the child from the left side and immediately befo
re the
immunization. The section of cartoon chosen was started at a point in a musical
number
to be optimally engaging
2.BlankTVScreenControl (n = 33): Same initial procedure as treatment group; howe
ver,
in this in this group, the TV was not turned on
Outcomes 1. Parent ratings of child anxiety before procedure on 10 cm VAS (1 = n
o anxiety, 10 =
worst anxiety imaginable)
2. Child self-report of pain immediately after procedure using the Faces Pain Sc
ale (FPS)
3. Blinded experimenter ratings of pain fromvideotaped procedures using the Chil
dren's
Hospital of Eastern Ontario Pain Scale (CHEOPS)
4. Blinded experimenter ratings of pain from videotaped procedures using the Chi
ld
Facial Coding System (CFCS)
5. Two objective distraction scores for watch TV (i.e. time spent watching TV scre
en)
and watch needle (i.e. time spent watching needle) coded from videotaped procedure
s
by experimenters
Notes None
Risk of bias
bias)
Low risk subjects were randomly assignedusing a
standard randomization table p.110 Par 2
Allocation concealment (selection bias) Low risk Use of an open random allocatio
n schedule
(e.g., random number table)
All outcomes
Unclear risk No reasons for missing data provided and
unclear of potential impact on outcomes
rmit judgment
Other bias High risk Multiple potential sources of bias related
to study design and other problems (e.g.,
non-neutral control stimulus)
(performance bias)
All outcomes
blinded
bias)
All outcomes
Cavender 2004
Methods Allocation: Randomized - using a table of random numbers
Participants Needle Procedure: venepuncture or IV insertion
Inclusion:
- English-speaking between 4 and 11 years old
- had medical order written for venepuncture or IV insertion
Exclusion:
- children with chronic illness
- children presenting with possible child abuse
N: 43
Age: 4-11 years old (M = 7.88 years, SD = 1.74 years)
Gender: M = 19, F = 24
Diagnosis: 11 = Surgical, 7 = Trauma, 9 = Vomiting, 4 = Other
Setting: Emergency department of a private, 322 - bed, paediatric
medical centre in the Southwestern United States
Interventions 1. Parental Positioning +Distraction (n = 20): In addition to rece
iving standard care, the
parents in this group were taught by a child life specialist, using a standard s
cript, how
to position and distract their child during venepuncture. The two types of posit
ioning
included side-sitting (parent sat in chair next to exam table and child sat side
ways on
his/her lap) or chest-to-chest sitting (parent sat in chair next to exam table a
nd child
sat on his/her lap chest-to-chest). The parent and patient decided which of the
two
types of positioning to use based on age and size of the patient and parent. In
addition,
all patients in the experimental group chose from one of three distraction items
to use
during the procedure. These included the Illusion Kaleidoscope (glitter suspende
d in a
fluid-filled tube passes before the lens when held to the eye and requires noman
ipulation
to change images), I Spy: Super Challenger book (child asked to find items hidde
n on
the page among multiple graphic designs) or Thomas the Tank Engine's Big Lift-and-
Look Book (child encouraged to open flaps to find hidden items). Following paren
tal
positioning, parents were instructed to engage their child with the distraction
by asking
the child repeated questions about the activity and reminding them to concentrat
e on
what they were saying and what they were asking the child (e.g., Look at the colo
rs in
the Kaleidoscope. Tell me what you see)
2. Standard Care Comparison/Control (n = 23): Children received the institution's
standard care for venepuncture, including a full explanation of the procedure an
d parental
presence for support
Outcomes 1. Child self-reported pain during procedure using the FACES scale
2. Child self-reported fear during the procedure using the Glasses Fear Scale
3. Parent and Child Life Specialist ratings of child fear during the preprocedur
al and
post-procedural time periods using the Glasses Fear Scale
4. Child Life Specialist ratings of child distress using the Procedural Behavior
Checklist
(PBCL)
Notes 'Positioning' (e.g., positioning the parent and/or child in such a way as to i
ncrease
proximity and comfort during the procedure)was not included as one of the interv
entions
explicitly assessed in this review because it was conceptualized as more of a ph
ysical
intervention than a psychological one.However,we still included this study in th
is review
under a separate intervention category called 'Parent Positioning + Child Distract
ion',
because the positioning was incorporated into the distraction and the distractio
n was a
Cavender 2004 (Continued)
fundamental component of the intervention
Risk of bias
bias)
Low risk randomly assignedby a table of random
numbers p.36 Par 2
on schedule
(e.g. random number table)
All outcomes
are reported
incompletely
an important risk of bias exists (e.g. reliability
of fear scale)
(performance bias)
All outcomes
blinded
bias)
All outcomes
Chen 1999
Participants Needle Procedure: three consecutive lumbar punctures (LPs; baseline
, post-intervention,
and follow-up)
Inclusion:
- diagnosis of Acute Lymphoblastic Leukemia (ALL)
- 3-18 years old
- English or Spanish speaking
Exclusion
- none given
N: 50
Age: 3-18 years (M = 7.3 years, SD = 3.7 years)
Gender: M = 67%, F = 33%
Diagnosis: Acute Lymphoblastic Leukaemia (ALL)
Setting: outpatient Children's Center for Cancer and Blood Diseases at the Childre
n's
Hospital Los Angeles
Chen 1999 (Continued)
Interventions 1. Brief Alteration of Memory Intervention (n = 25): Treatment was
conducted at two
time points: immediately following the first LP and before the second LP. Parent
s were
allowed to be present but did not actively participate. Children's memories of the
most
recent LP were elicited through a memory interview that tested for biases in rec
all
of threatening details, anxiety, and pain. In conducting the intervention, the t
herapist
encouraged children to (a) reevaluate their reactions to the last LP through enh
ancing
their beliefs about the efficacy of their own coping strategies (e.g., reminding
them
how asking the physician assistant questions helped them), (b) realistically app
raise their
responses to the LP (e.g., assessing the extent towhich they cried, screamed, or
protested),
and (c) increase the accuracy of their subjectivememory.The therapist and child
discussed
specific differences between the child's memories and observed behaviours or the c
hild's
previous self-report. Children were not taught coping skills but were encouraged
to
remember successful coping attempts that they naturally had made. To remind them
about the intervention techniques during subsequent procedures, children were of
fered
a fluorescent card that contained a cartoon drawing of a child thinking about hi
s or her
LP experience. Children wrote down memories discussed during the intervention on
the
card and then took the card into the procedure room. This card was intended to t
rigger
thinking about the intervention in the absence of the therapist (during future L
Ps)
2. Attentional Control (n = 25): Children spent the same amount of time with the
therapist as did the treatment group, both after the first and second LP, but we
re engaged
in non-procedure related activities (e.g., drawing). Children in both groups wer
e offered
support and encouragement by the nurse and physician assistant during LPs and re
ceived
preparation from the child life staff, including information and demonstration w
ith
dolls. However, children in the attention control group did not have a card to t
ake with
them during the LPs
Outcomes 1. Child self-reports of anxiety and pain on 10 cm vertical VAS
2. Parent ratings of child anxiety and pain using 10cm vertical VAS
3. Physician assistant performing the LP ratings of child's procedural distress on
the same
VAS (physical assistants not blind to treatment condition)
4. Pain and anxiety questions administered to all children; however, they were n
ot analysed
if the child was too young to understand
5. 35-item Memory interview
6. Procedure Behavior Check List (PBCL) coded by trained unblinded observers
7. Child systolic and diastolic blood pressure ratings
8. Child heart rate
9. Child salivary cortisol
Notes None
Risk of bias
bias)
Chen 1999 (Continued)
permit judgment
All outcomes
Low risk Reasons for missing data unlikely to be related
to true outcome
are reported
incompletely (i.e. number of participants
per group)
to study design and other problems (e.g.
potential impact of group setting)
(performance bias)
All outcomes
blinded
bias)
All outcomes
Eland 1981
Participants Needle Procedure: intramuscular injection
Inclusion:
- children scheduled for pre-kindergarten physical examinations
Exclusion:
- none given
N: 20
Age: 4.9-5.9 years
Gender: M = 20, F = 20
Diagnosis: none
Setting: private paediatrician's office in a Midwestern city with a population of
60,000
Interventions 1. Frigiderm Coolant with Cognitive Information (n = 10)
2. Frigiderm Coolant with No Cognitive Information (n = 10)
3. Control Aerosol Spray with Cognitive Information (n = 10)
4. Control Aerosol Spray with No Cognitive Information (n = 10)
Frigiderm Coolant (treatment condition): Altered the transmission of pain messag
es
from the skin surface by spraying a skin coolant on the injection site immediate
ly prior
to the injection
Cognitive Information (treatment condition): Attempted to alter the processing a
nd
interpretation of the pain stimulus by the use of positive suggestion. These chi
ldren were
told by the nurse immediately prior to the administration of the injection, I'm goi
ng
to spray something on your leg before your shot that will not hurt, will make yo
ur leg
Eland 1981 (Continued)
feel cool, and the spray will make this shot hurt less than other shots you've had
Aerosol Spray (control condition): Aerosol air was sprayed on the child's leg imme
diately
prior to the injection
No Cognitive Information (control condition): These children were told by the nu
rse
immediately prior to the administration of the injection, I'm going to spray someth
ing
on your leg before the shot
Outcomes 1. Child self-reports of pain using an adaptation of the tool used by L
oebach 1979 and
Shroeder 1979 comprised of eight 1 1/2 inch color squares placed across the bott
om
of a white felt board representing different events related to varying levels of
pain. To
compare the evaluation of pain according to the two levels of each treatment, in
tervals
on the colour scale were assigned numerical ratings. The most painful hurt was r
ated as
a 3, moderate pain was weighted a 2, mild pain a 1, and no pain a 0
2. Parent and nurse ratings of child anxiety. Parents and nurses were asked to r
ate the
child's anxiety about injections in one of three arbitrary categories: not anxious
(scored
as a 1), somewhat anxious (scored as a 2), or very anxious (scored as a 3)
Notes We used a total N of 20 for this study (instead of 40) because we only ass
essed 2/4
conditions (Control Aerosol Spray with Cognitive Information versus Control Aero
sol
Spray with No Cognitive Information). Also, in this study the description of Cogn
itive
Information was more in line with the definition of Suggestion as an intervention
technique, so it was classified as Suggestion rather than Preparation/Information in
the Results and Analyses
Risk of bias
bias)
permit judgment
All outcomes
rmit judgment
Other bias High risk Potential source of bias related to outcome
measurement (e.g. modified measure with
limited reliability p.370 Par 4)
(performance bias)
All outcomes
High risk Personnel were not blinded
Eland 1981 (Continued)
bias)
All outcomes
Low risk Unclear if participant blinding, but judged
not likely to influence outcome measurement
Fanurik 2000
Methods Allocation: Randomized - children were assigned to one of four stratifie
d age groups (2-
4 years, 5-8 years, 9-12 years, 13-16 years) and then randomized to the treatmen
t or
control group - no further details
Participants Needle Procedure: IV insertion
Inclusion:
- 2-16 years
- generally healthy
- would have EMLA applied for at least 60 min prior to their IV insertion
Exclusion:
- children with chart-documented, parent-reported, or suspected developmental de
lay
or cognitive impairment
N: 160
Age: 2-16 years
Gender: not reported
Diagnosis: none (but undergoing elective outpatient gastrointestinal endoscopy)
Setting: paediatric outpatients in the Gastroenterology Division of the Arkansas
Children's
Hospital
Interventions 1. Age-Appropriate Distraction (n = 80): Bubbles and musical sound
story books were
used with the two youngest age groups (2-4, 5-8 years). Sound story books and he
adsets
with a choice of a selection of music were used for children in the 9-12-year ol
d group,
depending on their preferences as well as staff assessment of attention span and
maturity.
Children 13 years and older listened to their choice of selection ofmusic throug
h headsets.
Distractionmaterialswere provided to the childrenwhile theywerewaiting to be cal
led to
the endoscopy suite, andwhen they arrived in the suite, nurses immediately engag
ed them
with the distraction materials. Parents were informed that although the nurses w
ould be
distracting their children, they could stand close and touch their children. Nur
ses had
been instructed in the use of distraction techniques by a paediatric psychologis
t
2. Typical Intervention Control (n = 80): Healthcare personnel interacted in the
ir usual
manner with the children but did not attempt to distract them from the procedure
.
Parents and children were asked to use whatever coping strategies whey would typ
ically
employ in this situation. An age-appropriate book was placed on the stretcher in
clear
view of the parents and children before the family entered the treatment room (a
lthough
no specific instructions were given about using the book)
Outcomes 1. Child self-reports of pain and anxiety using 100 mm VASs obtained fo
r children 5
years of older after IV was taped in place and prior to administration of medica
tion for
sedation
2. Three ratings of behavioral distress (pre-procedure, procedure, post-procedur
e) were
recorded on a 6-point numerical scale (0 = not at all distressed, 5 = extremely
distressed)
by one of the GI specialty nurses (not involved in themedical procedure or inter
vention)
Fanurik 2000 (Continued)
, or a research assistant (nurses and research assistants were not blind to expe
rimental
group)
3. Parental predictions of child anxiety during IV insertions using 100 mm VAS
4. Behaviours of the children and parents in the comparison group were recorded
by
observers in a brief narrative form (coded as 'distraction' or 'non-distraction' strateg
ies)
Notes None
Risk of bias
bias)
permit judgment
All outcomes
High risk Imbalance in numbers for missing data
across intervention groups
are reported
incompletely
an important risk of bias exists
(performance bias)
All outcomes
blinded
bias)
All outcomes
Fowler-Kerry 1987
Methods Allocation: Randomized - randomly assigned with the restriction that the
re be equal
numbers of boys and girls in each group- no further details
Participants Needle Procedure: immunization
Inclusion:
- healthy children 4.5-7 years old
Exclusion:
- none given
N: 160
Age: 4.6-6.2 years (M = 5.5 years)
Gender: M = 100, F = 100
Fowler-Kerry 1987 (Continued)
Diagnosis: none
Setting: patients attending one of three community health clinics located near a
large
metropolitan area
Interventions 1. Distraction (n = 40): Subjects had headphones placed over their
ears and a piece of
music suitable for children was played immediately prior to and during the injec
tion
2. Suggestion (n = 40): Subjects were told that the experimenter was going to he
lp them
when they had their injection. The headphones were placed over their ears but no
music
was played
3.Distraction + Suggestion (n = 40): Subjects received both themusic and the sug
gestion
of assistance with pain relief
4. Control condition with headphones (n = 40): Subjects did not receive distract
ion or
suggestions, but did wear headphones
5. Control condition without headphones (n = 40): Subjects did not receive distr
action
or suggestions, and did not wear headphones
*Note: The study results combined the two control conditions into one overall co
ntrol
group of 80 participants
Outcomes Child self-report of pain using four-point VAS (0 = no pain, 3 = most p
ain possible)
where subjects were shown a card with four equal sized blocks representing the r
ange of
pain of the scale and asked to point to the block which represented their pain
Notes We used a total N of 160 for this study (instead of 200) because we only a
ssessed 4/5
conditions (Distraction versus Combined 2 Control Conditions and Suggestion vers
us
Combined 2 Control Conditions)
Risk of bias
bias)
permit judgment
All outcomes
rmit judgment
an important risk of bias exists (e.g., failure
of suggestion may be attributed to an
ineffective suggestion statement p.174 Par
2)
Fowler-Kerry 1987 (Continued)
(performance bias)
All outcomes
High risk Although authors report blinding of participants
and personnel, the nature of psychological
intervention precludes this
bias)
All outcomes
(see previous comment)
Gold 2006
Methods Allocation: stratified according to age (7-9, 10-12), then randomized to
condition
Participants Needle Procedure: paediatric IV placement
Inclusion:
-awaiting outpatient MRI or CT scans required IV placement
Exclusion:
-children with known or reported cognitive disabilities
-taking pain medication
-children who did not pass the cognitive and physical screening
N: 20
Age: 8-12 years
Gender: F=8, M=12
Diagnosis: heterogeneous, 12/20 had medical conditions
Setting: Children's hospital, Department of Radiology
Interventions 1. Virtual Reality (VR) Distraction (n= 10): This intervention inv
olved a VR distraction
presented via a head-mounted display. The virtual environment (VE), Street Luge,
by
Fifth Dimension Technologies (5DT), featured a fast-moving reality-based world i
n
which the player races downhill lying on top of a big skateboard. The VE was pre
sented
via the 5DT HMD 800, a high-performance professional HMD that provides active
matrix LCDs with full SVGA (800 600 3 [rgb]) pixel resolution. An InterSense Ine
rtia
Cube2 with a 3-degrees-of-freedom (DOF) tracker was attached. The player navigat
ed
through the VE with a Logitech rumble pad that provided tactile feedback and mus
ic
via headphones, thus supplying a multi-sensory immersive experience. The HMD was
connected to a Dell laptop (<www.dell.com>), Inspiron 8500 with 2.6-GHz processi
ng
speed and 1GB of RAM, operating onMicrosoftWindows XP and aNVIDIAGeForce4
4200 Go video card. Children in this treatment group received the VR interventio
n plus
standard care. They began interacting with the VE 5 minutes prior to the IV plac
ement,
continued play throughout, and interacted with the VR for 5 subsequent minutes
2. Standard Care (n= 10): Topical anesthesia spray prior to IV placement, with n
o
distraction. Children in this control group received only standard care and no V
R. They
were given an opportunity to play with the VR for
3 min following the completion of their IV placement.
Outcomes Pain and Distress measures:
1. Faces Pain Scale-Revised (FPS-R) to assess affective pain (worry about both r
elated to
pain
2.Wong Baker FACES PainRating scale to assess affective pain (worry about both r
elated
Gold 2006 (Continued)
to pain
3. Visual Analog Scales (VASs) to assess pre-existing pain, IV pain intensity, p
ast IV pain
intensity, and anticipatory anxiety about the current procedure
Notes Other outcome measures not specifically related to procedural pain and dis
tress were
also used (e.g., measures for anxiety sensitivity, sickness, engagement, etc) bu
t are not
reported here because they were not relevant to this review. Similarly, VAS anti
cipatory
anxiety was also assessed but was not included in our analyses because we focuse
d on
anxiety during the procedure
Risk of bias
bias)
permit judgment
All outcomes
are reported
incompletely (i.e. nurse and parent
report)
Other bias High risk Small sample size potential source of bias
affecting outcomes
(performance bias)
All outcomes
blinded
bias)
All outcomes
Gonzalez 1993
Methods Allocation: Randomized - using a block randomization procedure that took
age into
account - no further details
Participants Needle Procedure: routine injections
Inclusion:
- none given
Exclusion:
- none given
Gonzalez 1993 (Continued)
N: 28
Age: 3-7 years
Gender: M = 21, F = 21
Diagnosis: none
Setting: recruited from the general pediatric primary care clinic at a large, ur
ban public
hospital
Interventions 1. Maternal Reassurance (n = 14): Mothers received: (a) oral instr
uctions on how to
reassure their child verbally during themedical procedure, (b) listened to an au
dio cassette
of a parent demonstrating the type of verbal reassurances that should be used, a
nd (c)
practised their reassuring verbal strategies with the help of an assistant. Moth
ers were
also instructed to engage in reassurance throughout the recording period
2. Distraction (n = 14). Mothers received: (a) oral instructions on how to distr
act their
child verbally during the medical procedure, (b) listened to an audio cassette o
f a parent
demonstrating the type of distractions that should be used, and (c) practiced th
eir distracting
verbal strategies with the help of an assistant. Mothers were also instructed to
engage in distraction throughout the recording period
For both the Maternal Reassurance and Distraction groups, a large sign with exam
ples
of appropriate vocalizations was posted approximately 2 metres from the parents
to help
cue them during the medical procedure. Throughout the procedure a research assis
tant
pointed to the sign each time themother stopped engaging in the appropriate voca
lization
for more than 10 seconds. The two research assistants who were present throughou
t the
procedure did not interact with the mother or child in any other manner
3. Control (n = 14): Mothers received a short lecture on transportation to the h
ospital,
listened to an audio cassette that provided additional information about transpo
rtation,
and discussed transportation issues with a research assistant
Outcomes 1. Research assistant ratings of child distress using theModified Frank
l Behavior Rating
Scale
2. Child self-report of pain during the procedure using the Oucher Pain Rating S
cale
3. Observers blind to group assignment ratings of child distress during the proc
edure,
using the Observational Scale of Behavioral Distress-Revised (OSBD-R) coded from
videotapes of the injection for the injection and post-injection time periods
4.Observers blind to group assignment ratings of parental adherence to the exper
imental
manipulation using the 'nonprocedure-related talk' and 'reassuring comment' codes of
the Child-Adult Medical Procedure Interaction Scale (CAMPIS)
essed 2/3
conditions (Distraction versus Control). This is because there is already consid
erable
existing research to suggest that reassurance is a distress-promoting strategy,
and was
therefore not included as one of the interventions assessed in this review
Risk of bias
bias)
Gonzalez 1993 (Continued)
permit judgment
All outcomes
rmit judgment
(performance bias)
All outcomes
bias)
All outcomes
of 'low' or 'high' risk (e.g. research
assistant ratings)
Goodenough 1997
Methods Allocation: Randomized - stratified by age - no further details
Inclusion:
- children aged 3-17 years consecutively scheduled to undergo venepuncture
Exclusion:
- children with a major mental handicap
N: 78
Age: 3.5-17.7 years
Gender: M = 73, F = 44
Diagnosis: none (although 36 children were undergoing venipuncture as part of on
going
investigation for chronic illness)
Setting: Sydney Children's Hospital
Interventions 1. Placebo Cream + Suggestion (n = 39): The placebo cream involved
a disinfectant
handwash which was odourless thick white foam with no anesthetic properties. The
suggestion involved having the nurse say to the child We are trying out a new spe
cial
cream. I am going to put some cream on your arm that might make it (the needle)
hurt
less. In this condition, the cream was dispensed from a brightly wrapped containe
r as a
means of visually reinforcing the child's expectancy that the cream might help
2. Placebo CreamAlone (n = 39):Only application of the placebo creamdescribed ab
ove
with no suggestion. In this condition, the nurse said to the child I amgoing to p
ut some
cream on your arm and the cream was dispensed from a plain while wrapped containe
r
For both of the above conditions using the placebo cream, the cream was applied
to the
arm with cotton wool, rubbed into the skin, and the excess was removed using cot
ton
wool
Goodenough 1997 (Continued)
3.No Cream Control (n = 39): No creamwas applied and the nurse did not say anyth
ing
beyond standard procedural instruction
Outcomes 1. Child self-report of pain using the Faces Pain Scale (FPS)
2. Child self-report of anxiety using the Children's Anxiety and Pain Scale (CAPS)
3. Child self-report of whether the cream had helped to reduce the needle-pain
4. Observer ratings of child behavioral reaction to pain during the needle
Notes We used a total N of 78 for this study (instead of 117) because we only as
sessed 2/3
conditions (Placebo Cream + Suggestion versus Placebo Cream Alone)
Risk of bias
bias)
permit judgment
All outcomes
to true outcome
rmit judgment
affect outcomes
(performance bias)
All outcomes
bias)
All outcomes
Gupta 2006
Methods Allocation: prospective randomized study, randomized with a computer-gen
erated table
of random numbers
Participants Needle Procedure: venepuncture venous cannulation
Inclusion:
-children aged 6-12 years, ASA physical status I-II, undergoing venous routine s
urgical
procedures
Exclusion:
Gupta 2006 (Continued)
-children with delayed milestones, cardiac or neurobiological impairment, or fai
lure to
cannulate on first attempt
N: 75
Age: 6-12 years
Gender: F=31, M=44
Diagnosis: paediatric patients, ASA physical status I-II, undergoing elective su
rgery
Setting: not specified (just states that procedure was done in preoperative area)
Interventions 1.Distraction group (n=25): Patients were given a rubber ball (whi
ch produces a squeaky
sound on being compressed) in the palm of their hand which was not to be cannula
ted.
The patients were asked to alternately compress and release the ball
2. Balloon group (n=25): Patients were asked to inflate a balloon at least for 2
0 seconds
before initiation of the venipuncture. The cannula insertion was performed durin
g the
act of forceful expiration. A small plastic hollow pipe was attached to the end
of the
balloon from where it is inflated and fixed to make the assembly easier to hold
with
one hand, thus making the act of inflation easier. According to study authors, b
alloon
inflation may have a combined effect of distraction and increasing intrathoracic
pressure
making the veins more prominent and easier to cannulate
3. Control group (n=25): Patients did not press a rubber ball nor were they aske
d to
inflate a balloon
Outcomes Pain:
Self-report: VAS (10cm). On back of Pain Face Scale. Children placed sliding mar
ker
between extreme anchors/faces. Administered during venepuncture
Notes None
Risk of bias
bias)
Low risk consecutive pediatric patients were randomized
with a computer generated table
of random numbers p.1372 Par 3
permit judgment
All outcomes
Selective reporting (reporting bias) High risk One or more outcomes reported inc
ompletely
for inclusion in meta-analysis
Gupta 2006 (Continued)
(performance bias)
All outcomes
blinded
bias)
All outcomes
Harrison 1991
Participants Needle Procedure: venous blood sampling
Inclusion:
- 6-12 year olds reporting to four hospital laboratories in Kuwait
Exclusion:
- none given
N: 100
Age: 6-12 years
Gender: M = 51, F = 49
Diagnosis: none
Setting: four hospital laboratories in Kuwait
Interventions 1. Preparation (n = 50):Children in this groupwere read a preparat
ion story accompanied
by pictures, and were encouraged to ask questions. The story offered a simple de
scription
of the venous blood sampling procedure, why it is carried out, and what happens
to the
blood after it has been collected. It emphasized that the procedure creates a br
ief period
of pain, and that the pain is noticeable but not unbearable. The story also stre
ssed that
venepuncture is less painful if a child relaxes his arm and cooperates with the
technician.
In order to increase the likelihood of children modeling the behaviour of the ch
ild
featured in the story, sex- and age-appropriate models of average appearance wer
e used,
and local children, parents, and hospital settings were photographed
2. No Preparation control (n = 50): No specific description of this group was me
ntioned
in the study. However, it was noted that initial observations revealed that labo
ratory
technicians generally made no attempt to prepare children for venepuncture or to
talk
them through the procedure. If children protested and struggled, their strategy
was to
physically restrain the child and complete the procedure. Often, parents were re
cruited
to help
Outcomes 1. Child self-report of pain using 6-point histogram VAS
2. Parent observer-report of pain and fear using 0-5 scale
2. Radial pulse rates of children before and after the procedure
3. Parent responses to questions related to the procedure
Notes None
Risk of bias
Harrison 1991 (Continued)
bias)
permit judgment
All outcomes
Unclear risk Insufficient reporting of exclusions to permit
judgment of low or high risk (e.g.
some parent-report missing)
rmit judgment
specific study design (e.g. potential impact
of group setting)
(performance bias)
All outcomes
High risk Study participants were not blinded
bias)
All outcomes
Huet 2011
Methods Allocation: Randomized - randomly assigned by lottery
Participants Needle Procedure: local dental anaesthetic using standard metal syri
nge without electronic
assistance after applying a topical anesthetic for 1 min to the area where local
anesthetic would be injected
Inclusion:
Exclusion:
N: 29
Age: 5-12 years old (Median = 9 for control group and 8 for intervention group)
Gender: M = 16, F = 13
Diagnosis: none
Setting: Department of Pediatric Dentistry at Rennes University Hospital
Interventions 1. Hypnosis Intervention (n = 14, + 1 excluded from analyses): Hyp
nosis was performed
following the usual three-step Ericksonian procedure. Hypnotic induction began o
nce
the subject was seated in the dentist's chair. Speaking slowly in a monotone voice
, the
hypnotherapist made the child focus on her (hypnotherapist) voice and on images
to
establish a hypnotic relation, first taking into account items in the room and the
n
using suggestions and stories. The suggestions or stories used during the induct
ion were
Huet 2011 (Continued)
linked with things the child was interested in and were chosen according to the
initial
interview. The child could express any discomfort using a predefined code. All e
xternal
interventions (e.g., examination with the mirror, placement of towels, injection
) were
carried out with agreement of the hypnotherapist, who incorporated these interve
ntions
in her explanations to the child. A hypnotic trance was considered to have been
achieved
when the hypnotherapist noted muscular relaxation, regular breathing, and immobi
lity
(cataleptic state). The dental anesthesia and treatments were then performed. Th
e hypnotherapist
continued speaking to the child to maintain the state of trance. At the end
of the treatment session, the hypnotherapist gradually awoke the child by speaking
a
little bit louder and using the items in the room to help the child come back to
the initial
conscious state. The hypnosis was performed by a single trained operator
2. No-Hypnosis Control (n = 15): The same general procedure as described above w
as
also used for all the children in this group, except for the hypnosis
Outcomes 1. Child self-report of pain: Visual Analogue Scale (0-10)
2. Modified Objective Pain Score (MOPS) (0-10 score)
3. Modified Yale preoperative anxiety scale (mYPAS)
Notes None
Risk of bias
bias)
Low risk randomly assigned by lottery (p.426)
permit judgment
All outcomes
Low risk Missing data minimal and unlikely to be
related to true outcome
are reported
incompletely
(performance bias)
All outcomes
blinded
bias)
All outcomes
Inal 2012
Methods Allocation: computer-generated table of random numbers into 2 approx equ
al groups
Participants Needle Procedure: blood draw (venepuncture) x1
Inclusion:
- 6-12 year old patients who required blood tests
Exclusion:
-neurodevelopmentally delayed
-verbal difficulties
-hearing or visual impairments
-have taken an analgesic within the last 6hrs
-had a history of syncope due to blood draws
N: 123
Age: 6-12 years
Gender: F=61, M=62
Diagnosis: unclear; non-chronic illness status (n=49 control; n=53 experimental)
, chronic illness (n=13 control, n=8 experimental) e.g., diabetes, CF, thalassaemi
a,
coeliac
Setting: paediatric clinic, Istanbul, Turkey
Interventions 1.Distraction group (n = 61):Children looked through 5 x 8 cmFlippi
ts (R) distraction
cards which consisted of various pictures and shapes. The same nurse asked the c
hild
questions about the cards during the blood draw procedure that child only answer
if he/
she examined the cards carefully. The blood-drawing procedure started when the c
hild
began looking at the distraction cards carefully. Questions were asked about the
cards
until the end of the procedure (e.g., how many spots do the ladybugs have in tota
l?)
2. Control group (n = 62): Children received no intervention
Outcomes Pain:
Child self-report: FPS-R
Caregiver/Parent-Report: FPS-R
Nurse report: FPS-R
Anxiety:
Caregiver/Parent Report: Anxiety set of children's Anxiety and Pain Scales (CAPS)
-
higher is more anxiety
Nurse Report: Anxiety set of Children's Anxiety and Pain Scales (CAPS)
Notes None
Risk of bias
bias)
Low risk randomized with a computer-generated
table of random numbers p.212 Par 6
on schedule
Inal 2012 (Continued)
All outcomes
rmit judgment
(performance bias)
All outcomes
blinded
bias)
All outcomes
Jeffs 2007
Methods Allocation: 'randomly assigned to groups' 'using computer generated random num
bers
table'
Participants Needle Procedure: Phase II of allergy testing involving injection
Inclusion: early and middle phase adolescents aged 11-17 years
-environmental or food allergen testing
-parental presence
-ability to read and write English
Exclusion:
-bee venom allergy testing
-cognitive and developmental disability (determined by presence of individual ed
ucational
plan or accommodation that parents identified as related to cognitive delay)
N: 27
Age: 11-17
Gender: F=15, M=17
Diagnosis: not specified explicitly but practice was for allergy, asthma, and im
munology
patients
Setting: outpatient allergy, asthma, and immunology medical practice within larg
e medical
centre
Interventions 1. Self Selected Distraction (n = 9): This group made one selectio
n from an investigatordeveloped
collection of music CDs, including alternative, hip-hop, pop, pop country,
and rock music. Popular teen books on cassette and videotapes, including movies,
music
videos, sports programs, and cartoons, were also available. Several adolescents
who were
not study participants assisted in the selection of the media
2. Investigator Selected Distraction (n = 10): This group watched a nursing recr
uitment
videotape targeting an adolescent audience that showed interviewswith nurses, id
entified
various nursing roles, and explained the work performed by nurses
Both distraction groups listened to themedia through headphones. Allmedia and eq
uip-
Jeffs 2007 (Continued)
ment were new and provided by the researcher. Distraction was implemented in the
intervention groups just prior to and continuously during the actual allergy tes
ting procedure.
The physicians' office nurses, who conducted the allergy testing, were directed
to avoid interrupting the distraction
3. Usual Care Control (n= 8): The UC group received the typical care provided by
the
physicians' office nurses who performed the allergy skin testing without any scrip
ting or
prompting. Usual care consisted of the typical communication between the office
nurse
and adolescent about non-allergy testing topics, such as favourite school subjec
ts and
sports, as well as allergy testing information. The UC group received no experim
ental
intervention.Allergy testingmaterialswere keptwithin viewof the adolescent; no a
ttempt
was made to conceal testing materials
Outcomes Self-Report Pain:
Adolescent Pediatric Pain Tool (used pain rating for data extraction)
Wong Baker FACES Scale (0-10)
Notes Phase I allergy testing was used to determine the presence of non-reactive
allergens.
Distraction was resumed during Phase 2 testing, therefore only Phase II testing
was used
in the analyses for this review. Phase 1 involved an N of 32 while Phase 2 invol
ved and
N of 27; therefore, the total N reported for this study is 27. Also, the two dis
traction
conditions were pooled together to create one overall distraction condition
Risk of bias
bias)
Low risk p.175 Par #2 participants randomly assigned
using a computer-generated random
numbers table
Allocation concealment (selection bias) Unclear risk Unclear if all appropriate
safeguards taken
with assignment envelopes (i.e., sequentially
numbered or opaque)
All outcomes
Low risk No missing data for phase included in current
review
rmit judgment
study design and other problems (e.g., low
statistical power)
(performance bias)
All outcomes
High risk p.172 Par #7 unblinded experimental design
Jeffs 2007 (Continued)
bias)
All outcomes
High risk p.172 Par #7 unblinded experimental design
and no blinding of self-report of outcome
assessment
Katz 1987
Methods Allocation: Randomized - stratified by sex - no further details
Participants Needle Procedure: bone marrow aspiration (BMA) (approximately 50% o
f the children
also underwent a lumbar puncture immediately following their BMA)
Inclusion:
- baseline self-reported pain score > 50 (possible range: zero to 100)
- baseline self-reported fear score > 4 (possible range: 1 to 7)
- Procedural Behavior Rating Scale-revised score > 4 (possible range: zero to 33
)
- nurse rating of child anxiety > 3 (possible range: one to five)
Exclusion:
- none given
N: 36
Age: 6-11 years old (M = 8.3 years, SD = 1.68 years)
Gender: M = 24, F = 12
Diagnosis: Acute lymphoblastic leukaemia (ALL)
Setting: Hematology-Oncology clinic at the Children's Hospital of Los Angeles
Interventions 1. Hypnosis (n = 18): Comprised training in hypnosis and self-hypn
osis by one of two
psychologists experienced in psychological aspects of oncology and hypnosis. Maj
or
components of this intervention included the development of rapport, direct disc
ussions
about the child's medical history and treatment needs, a hypnotic induction utiliz
ing
eye fixation with or without eye closure, active imagery tailored to the interes
ts of each
individual child, deep muscle relaxation, and suggestions. The specific suggesti
ons incorporated
were as follows: imagery to reduce or reframe sensory/pain experiences; distract
ion
and relaxation; pairing positive affect with medical procedures; developing a
sense of mastery and control over sensory and affective experience; and post-hyp
notic
suggestions for practicing and re-entering hypnosis with a cue fromtheir therapi
st during
actual procedures
2. Play control condition (n = 18): This condition was comprised of non-directed
play
sessions designed to control for the amount of time and attention the child rece
ived from
a sympathetic hospital professional (i.e., the psychologists performing the inte
rventions)
. Subjects in this condition were seen prior to BMAs for the same amount of time
as
those in the hypnosis condition and by the same psychologists. Elements of the n
ondirected
play condition included development of rapport, non-medical play, and nomedical
verbal interactions. No discussions about the child's illness or treatment were
initiated. If the child initiated such conversations, the therapists subtly chan
ged the
subject
Outcomes 1. Observer ratings of child distress during three temporal phases usin
g the Procedural
Behavior Rating Scale- Revised (PBRS-R)
2. Nurse ratings of child anxiety during the procedure using one to five Likert
scale
3. Child self-report of fear during the procedure using the Fear Self-Report mea
sure
Katz 1987 (Continued)
4. Child self-report of pain during the procedure using the Pain Self-Report (co
mprised
of a graphic rating scale patterned after a thermometer where 0 = no hurt at all
, and 100
= the most hurt possible)
5. Therapist ratings of rapport with patient and child's response to hypnosis on o
ne to
five scale (1 = excellent, 5 = poor)
Notes Outcomes were assessed at baseline and intervention with repeated measures
on the
intervention condition as there were 3 BMAs (i.e., Baseline, Post-Treatment 1, P
ost-
Treatment 2, and Post-Treatment 3). Each subject was seen for two intervention s
essions
prior to their next BMA and sessions were 30 minutes long. For the purpose of th
is
review, we only used data from the first BMA procedure (i.e., Post-Treatment 1)
Risk of bias
bias)
permit judgment
All outcomes
rmit judgment
Other bias High risk Potential source of bias related to timing
of outcome measurement (e.g., sometimes
after multiple procedures)
(performance bias)
All outcomes
bias)
All outcomes
Kleiber 2001
Methods Allocation:Randomized - permutated block randomization used to assure th
at a balanced
number of children with histories of high distress were randomized to the contro
l and
experimental groups; randomization conducted according to the procedures outline
d by
Friedman et al, 1996. Randomization achieved using a table of random numbers (se
e
note)
Participants Needle Procedure: IV Insertion
Inclusion:
- no neurological or sensory impairment at the IV site
- child able to distinguish between biggest and smallest in order to Oucher pain
scale
- parent with legal custody agreed to be with the child during the procedure
- parent able to speak and read English
Exclusion:
- none given
N: 44
Age: 4-7 years
Gender: M = 11, F = 33
Diagnosis: children being treated or evaluated for non-life threatening conditio
ns such
as chronic urinary tract infections, urinary incontinence, chronic constipation,
growth
failure, and reactive airway disease
Setting: largeMidwestern tertiary care hospital that serves as the primary speci
alty referral
site for a population of approximately three million people. It is located in a
state in
which the population is predominantly Caucasian, with other races accounting for
5%
of the population
Interventions 1. Parent Coaching + Distraction (n = 22): Parents viewed a 7-minu
te educational video
on distraction that was developed for this study (available from authors upon re
quest)
. The children remained with their parents during the video, and were encouraged
to
watch it. The narration tells the viewer why and how distraction should be used
with
children. The viewer is given suggestions on how to choose themost effective dis
traction
strategy. Three parents model distraction with their preschool aged children and
explain
why they found distraction to be helpful. Finally, parents are told to involve t
he child in
choosing the distraction and to praise the child at the end of the procedure. Th
e video
ends with a written summary of the following key points: (a) Focus your child's at
tention
away from the medical procedure, (b) use activities that keep your child's attenti
on
(interactive books, blowing bubbles, surprise or novel toys, favourite stories),
(c) if you
lose your child's attention, keep trying to get it back, (d) using distraction tak
es some
effort, but it can help you child feel more comfortable, and (e) praise your chi
ld at the
e4nd of the procedure. After viewing the video, the parents and children were sh
own a
basket of distraction items and were encouraged to pick something to use during
the IV
insertion
2. Standard Care Control (n = 22): Standard practice in this setting was for ind
ividual
practitioners to decide whether or not to apply a topic anesthetic cream (EMLA)
at the
IV site. Parents were invited to accompany their child to the procedure room and
stay
during the IV insertion. They received no instruction on what to do during the i
nsertion
Outcomes 1. Parent ratings of child's previous distress during medical procedures
using a sevenpoint
scale
2. Child self-report of pain during the IV insertion using the Oucher Scale
3. Parent ratings of child distress using the Perception of Procedures Questionn
aire-
Kleiber 2001 (Continued)
Revised (PPQ-R)
4. Observer ratings of child distress using the Observer Scale of Behavioral Dis
tress-
Revised (OSBD-R)
5.Observer ratings of parent distraction behavior coded fromvideotapes (each 10-
second
interval of the procedure coded for the presence/absence of parental distraction
)
Notes Although it was not stated in the paper, personal communication with the a
uthor confirmed
that randomization was achieved via a random table of numbers
Risk of bias
bias)
permit judgment
All outcomes
to true outcome and balanced across
intervention groups
are reported
incompletely
study design and other problems (e.g., low
reliability of parent outcome measure)
(performance bias)
All outcomes
bias)
All outcomes
High risk No blinding of self-report and parent-report
of outcome assessment
Kristjansdottir 2010
Methods Allocation: table of random numbers
Participants Needle Procedure: Polio Immunization
Inclusion:
-Icelandic-speaking adolescents scheduled for a ninth grade immunization
Exclusion:
none listed
N: 118
Kristjansdottir 2010 (Continued)
Age: 13-15
Gender: F=55, M=63
Diagnosis: healthy (community sample attending school)
Setting: school, Iceland
Interventions 1. Music Distraction with Headphones (n = 38): Participants were a
sked to wear headphones
to listen to music
2. Music Distraction without Headphones (n = 41): Participants were not asked to
wear headphones to listen to music. Instead, they were asked to listen to music
from
loudspeakers
In designing the intervention, therapeutic nursing intervention guidelines on di
straction
to relieve pain andmusic therapywere used. In addition, amusic therapist was con
sulted.
The intervention protocol was the same for both intervention groups and included
the
following: (a) explaining the purpose of the music to the adolescents (i.e., to
distract and
to help themcope during/after the immunization), (b) asking themto concentrate o
n and
`disappear into' the music, and continue to do so for a few minutes (2-3 minutes) be
fore
and after the immunization, and (c) creating a sense of control in the adolescen
ts by
giving them choice (i.e., selecting a CD and controlling the volume setting). Th
e music
for the study was selected based upon results from a pilot study. Using a hypoth
etical
immunization, 6 teens (13-15 years old) were interviewed showing they preferred
top ten
chart music to relaxing music during the immunization. Acknowledging this, the m
usic
used in the study was largely chosen from top 10 charts of the day, with the exc
eption
of one relaxing classical CD. In selecting the top ten chart music for the study
, advice
from a music marketing manager who knew adolescent music preferences, was sought
3. Standard Care Control (n = 39): The school nurses were encouraged to maintain
their
normal modes of caring, which was to comfort and guide the adolescents verbally.
If
the adolescents had any questions or concerns prior to the immunization, or disc
omfort
after the immunization, the school nurses responded to these with care
Outcomes Pain:
Self-report: VAS (0-10)
Notes The data from the two distraction conditions were pooled together to creat
e one overall
distraction condition
Risk of bias
bias)
Low risk table of random numbers was used to randomize
into groups (p.20 Par 11)
on schedule (e.
g., random number table)
All outcomes
Kristjansdottir 2010 (Continued)
rmit judgment of
'low' or 'high' risk
Other bias Unclear risk Insufficient information to assess whether an
important risk of bias exists
(performance bias)
All outcomes
blinded
bias)
All outcomes
Kuttner 1987
Participants Needle Procedure: bone marrow aspiration (BMA)
Inclusion
- leukaemia patients who had expressed difficulty in coping with the recurrent B
MAs
and Lumbar Punctures (LPs) that constituted an essential part of their treatment
for
cancer
- children 6 years old and younger
Exclusion
- none given
N: 25
Age: 3-6.11 years (larger study compared 3-6 year olds with 7-10 year olds but t
his paper
reports results of younger group only)
Diagnosis: Leukaemia
Setting: treatment/surgery room - no further details
Interventions 1. Hypnosis (n = 9): This group received the hypnotic techniques i
n which the child's
favourite story became the hypnotic vehicle to create a pleasant imaginative inv
olvement
that would lead to a different interpretation of the noxious experience. The fav
ourite
stories included hypnotic suggestions and reframing. Prior to the medical proced
ure,
the researcher asked the child to tell his/her favourite story, noted the child's
choice
of words and emphasis, and then suggested the following plan of action: `When we
go into the treatment room, how would it be if I tell the story of (insert child's
story
title) while the BMA gets done? I wouldn't be surprised if the procedure didn't go
much quicker, and by the time the story ends the band-aid will be on and everyth
ing
will be finished!' After a 10-20 minute induction and practice session, the resear
cher
accompanied the child and parent into the surgery room where, as soon as the chi
ld was
lying on the table, a trance was induced and maintained through the procedure. T
he
hypnotic process incorporated active involvement with the child, flexibility, in
formality,
and narrowed/increase absorption of attention. Procedural and sensory informatio
n was
interwoven into the story-line (e.g., indirect/direct suggestions for comfort, d
iminishing
Kuttner 1987 (Continued)
pain awareness, and increased coping within the story-line). The central charact
ers and
heroes/heroines were used as metaphors of courage and feelings of accomplishment
.
Parents were encouraged to be present and touch or hold the child's hand; however,
the
therapist was generally the only adult to talk with the child during the procedu
re
2. Distraction (n = 8): Physical objects such as pop-up books, bubbles, and sque
ezy
toys were used during the BMA to shift the child's attention away from the painful
procedure and onto these physical objects which contained elements of surprise,
play,
and opportunities for the child to demonstrate some accomplishment, instead of f
eeling
helpless. For example, the child was encouraged to count interesting objects in
the popup
book, or to blow bubbles, or was challenged to correctly name physical objects
3. Standard Medical Care Control (n = 8): This group received the standard medic
al
practice, which included providing some information, reassurance, and support
Outcomes 1. Observer ratings of child distress using the Procedure Behavior Rati
ng Scale- Revised
(PBRS-R)
2. Observer, physician, nurse, and parents ratings of child's pain and anxiety on
fivepoint
rating scales
3. Child self-report of pain and anxiety using an interval picture five-point sc
ale
Notes Data necessary for the meta-analysis data pooling (i.e., means and SDs) wa
s reported for
the PBRS-R only. Also, because there were two treatment sessions, data was repor
ted for
three time points (i.e., baseline, 1st intervention, 2nd intervention). For the
analyses in
this review, we used data for the 1st intervention only
Risk of bias
bias)
permit judgment
All outcomes
judgment of low or high risk. One
or more outcomes of interest are reported
incompletely
are reported
incompletely
study design (e.g., small sample size)
(performance bias)
All outcomes
blinded
Kuttner 1987 (Continued)
bias)
All outcomes
Liossi 1999
Methods Allocation: Randomized - table of random numbers (see note)
Participants Needle Procedure: bone marrow aspirations (BMAs; baseline and inter
vention)
Inclusion:
- Leukaemia patients between 5 and 15 years old whose medical protocol required
at
least two BMAs within 2.5 months
Exclusion:
- previous therapy with hypnosis and/or cognitive behavioral (CB) coping
- concurrent treatment during the project with analgesic or psychotropic medicat
ion
- a major affective disorder or other psychiatric diagnosis
N: 30
Age: 5-15 years (mean = 8 years, SD = 2.5 years
Gender: M = 17, F = 13
Diagnosis: Leukaemia
Setting: treatment room of clinic - no further details
Interventions 1. Cognitive Behavioural (CB) Intervention (n = 10): This conditio
n involved: (a) relaxation
training (two relaxation techniques were taught in the sessions: progressive mus
cle
relations, and an abbreviated form of autogenic relaxation; imagery was not incl
uded),
(b) breathing exercises (each child was instructed to take a deep breath and to
let it out
slowly while making a hissing sound), and (c) cognitive restructuring (included
training
in attention redirection and restructuring self-defeating cognitions; patients w
ere taught
to identify helpless or self-defeating thoughts and to interrupt and change thes
e using
prepared substitute positive coping thoughts such as I know I can do it, or affirm
ations
by focusing attention on neutral or pleasant events /objects or by occupying the
ir
attention through mental repetition of affirmations, songs, or prayers)
2. Hypnosis (n = 10): Hypnosis was induced by visual imagery (favorite place, ac
tivity,
or television program). Two relaxation techniques were taught in sessions: progr
essive
muscle relations and an abbreviated form of autogenic relaxation. Reference to p
atient
well-being, strengths, competence, and comfort were included in the image. Follo
wing
several minutes of hypnotic involvement, the patient was given analgesic suggest
ions.
Hypnotic suggestions included the following: request for numbness (tomake lower
back
go to sleep for a few minutes), topical anaesthesia (imaging painting numbing me
dicine
on our back), local anaesthesia (imaging injecting and anesthetic into the back)
, and
glove anaesthesia (let hand go numb and let the numb feeling transfer from the h
and to
back)
3. Standard Treatment Control (n = 10). All patients in this control condition a
s well as
patients in the above two treatment conditions received a standard lidocaine inj
ection
Outcomes 1. Child self-report of pain and pain-related anxiety during one BMA at
baseline (time
1) using a six-point faces rating scale (0 = no pain/anxiety, 5 = as much pain/a
nxiety
child can imagine)
Liossi 1999 (Continued)
2. Nurse ratings of child distress using the Procedure Behavior Checklist (PBCL)
3. Child's hypnotic ability assessed using a Greek translation of the Stanford Hyp
notic
Clinical Scale for Children (SHCS-Children)
Notes Although it was not stated in the paper, personal communication with autho
r confirmed
that randomization was achieved via a random table of numbers. Also, the authors
note
that verbal communication fromtherapist to child during the procedure comprised
brief
encouragements (e.g., You're doing fine, It's almost over) and were the same for
patients in all the groups. While the authors conceptualized these statements as
èncouragement',
other research literature would categorize these statements as `reassurance'
which has been shown to be a distress-promoting strategy. However, although this
could
potentially reduce the efficacy of the interventions, since all three conditions
received
these statements, this would not present as a confound and comparisons between g
roups
are still feasible. Lastly, outcomes were assessed at baseline and post-treatmen
t. For this
review, only post-treatment scores were used
Risk of bias
bias)
permit judgment
All outcomes
are reported
incompletely
Other bias High risk the small number of subjects in this study
seriously compromise power and may yield
spuriously high correlations p.112 Par 3
(performance bias)
All outcomes
bias)
All outcomes
Liossi 2003
Participants Needle Procedure: series of lumbar punctures (LPs) (baselines and u
sing intervention)
Inclusion:
- children with leukaemia or non-Hodgkin's lymphoma
- 6-16 years old
- undergoing regular lumbar punctures over a 4-year period
Exclusion:
-previous hypnosis treatment
-concurrent treatment during the project with analgesic or psychotropic medicati
on
-a major affective disorder or other psychiatric diagnosis
N: 60
Age: 6-16 years (mean = 8.63 years, SD = 2.86 years)
Diagnosis: Leukaemia or Non-Hodgkin's Lymphoma
Setting:Hematology/Oncology Department of theChildren'sHospital Aglaia Kyriakou,
Athens, Greece
Interventions 1. Direct Hypnosis with Standard Medical Treatment (n = 20): Hypno
tic suggestions
included: request for numbness (to make lower back go to sleep for a few minutes
),
topical anaesthesia (imaging painting numbing medicine on our back), local anaes
thesia
(imaging injecting and anaesthetic into the back), glove anaesthesia (let hand g
o numb
and let the numb feeling transfer from the hand to back), and switchbox (imagini
ng
using a switch to turn off or modulate incoming pain message nerve signals going
from
the body to the brain).
2. Indirect Hypnosis with Standard Medical Treatment (n = 20): Using metaphors o
f a
setting sun and Mexican food to imagine details scenes using various senses (e.g
., sight,
smell, taste), develop cues to experience immediate relaxation, and pictures way
s to adapt
to discomfort
Both the direct and indirect hypnosis groups ended with a post-hypnotic suggesti
on that
the hypnotic experience would be repeated during the actual medical procedure wi
th
the help of the therapist, and that this would provide comfort during the LP
3. Attentional Control with Standard Medical Treatment (n = 20): Included elemen
ts
such as development of rapport, non-medical play, and no-medical verbal interact
ions
(e.g., discussing school, activities, sports, etc). New coping skills were not i
ntroduced
4. Standard Medical Treatment (n = 20): Patients in this group received no thera
pist
contact or treatment intervention, but, like all patients, received standard int
erventions
provided by the hospital staff for pain control during LPs (i.e., medical and nu
rsing staff
offered information, support, and reassurance)
Outcomes 1. Child self-report of pain and anxiety during three consecutive LPs a
t baseline and for
two consecutive LPs with the intervention, using the six-point Wong and Baker fa
ces
rating scale
2. Nurse ratings of child pain during three consecutive LPs at baseline and duri
ng two
consecutive LPs with the intervention, using the Procedure Behavior Checklist (P
BCL)
3. Child self-reports of pain and anxiety during the first, third, and sixth LPs
in which
self-hypnosis was used
4. Hypnotic ability assessed within two weeks after the last LP using a Greek-tr
anslation
of the Stanford Hypnotic Scale for Children (SHCS-Children)
Notes The data from the two hypnosis conditions were pooled together to create o
ne overall
hypnosis treatment condition. We used a total N of 60 for this study (instead of
80)
because we only assessed 3/4 conditions (Direct + Indirect Hypnosis versus Atten
tional
Control with Standard Medical Treatment). Outcomes were assessed at various time
points; however, for this review we only used the 'intervention' time point
Risk of bias
bias)
permit judgment
All outcomes
rmit judgment
affect outcomes
(performance bias)
All outcomes
blinded
bias)
All outcomes
Liossi 2006
Methods Allocation: Randomized - table of random numbers
Participants Needle Procedure: series of lumbar punctures (LPs) (baselines and u
sing intervention)
Inclusion: Greek-speaking patients with leukaemia or non-Hodgkin's lymphoma - betw
een
6 and 16 years
- undergoing regular LPs
Exclusion:
- previous hypnosis treatment
- concurrent treatment during the project with analgesia or psychotropic medicat
ion
- major affective disorder or other psychiatric diagnosis
N: 30
Age: 6-16 years
Gender: M = 23, F = 22
Diagnosis: leukaemia or non-Hodgkin's lymphoma
Setting:Hematology/Oncology Department of theChildren'sHospital Aglaia Kyriakou,
Athens, Greece
Interventions 1. EMLA +Hypnosis (n = 15): The hypnotic induction procedurewas ad
apted according
to the child's age, interests, and cognitive and social development. References to
patient
well-being, strengths, competence, and comfort were also included in the inducti
ons.
Following several minutes of hypnotic involvement, the patient was given analgesi
c
suggestions including request for numbness, topical anaesthesia, local anaesthesi
a, glove
anaesthesia, and switchbox - Please see above descriptions for other studies by
same
authors (e.g., Liossi 2003) for more information about these components. The ses
sion
ended with a post-hypnotic suggestion that the hypnotic experience would be repe
ated
and would provide comfort during the actual medical procedure, when the therapis
t
would stroke the child's cheek. It was also mentioned that the application of EMLA
60
min before the LP would be an additional cue for the child to start relaxing and
start
feeling calm and ready for the procedure to follow
2. EMLA + Attention (n = 15): Elements of the intervention included development
of
rapport, non-medical play, and non-medical verbal interactions. New coping skill
s were
not introduced. During sessions, child and therapist were usually discussing sch
ool and
extracurricular activities as well as playing board games or assembling model ai
rplanes
or building brick walls, depending on the child's age and interests. Overall, the
therapist
was supportive and warm, encouraged the child to express freely his or her inter
ests, and
formed a close relationship with the child
3. EMLA only (n = 15): All patients received standard interventions provided by
the
hospital staff for pain control during LPs (i.e., medical and nursing staff offe
red information,
support, and reassurance, and EMLA cream was applied approximately 60 min
before the procedure)
Outcomes 1. Child self-reported pain using the Wong-Baker FACES Pain Rating Scal
e
2.Observer ratings of child distress and discomfort using the Procedure Behavior
Checklist
(PBCL)
3. Hypnotic ability assessed using a Greek translation of the Stanford Hypnotic
Scale
for Children (SHCS-Children)
essed 2/3
conditions (EMLA + Hypnosis versus EMLA + Attention). Outcomes were assessed at
various time points; however, for this review we only used the outcomes assessed
closest
to the procedure (i.e., during the procedure or after the procedure if a during
procedure
outcome was not available)
Risk of bias
bias)
Low risk randomly allocatedwith the use of a table
of random numbers p.308 Par 9
on schedule
All outcomes
rmit judgment
affect outcomes
(performance bias)
All outcomes
bias)
All outcomes
Liossi 2009
Methods Allocation: randomly allocated using a computer-generated random positiv
e integers,
computer generated randomization sequence
Participants Needle: venepuncture for blood sampling
Inclusion:
-Greek-speaking patients with cancer
-between 7-16 years who were off active treatment and undergoing regular venepun
cture
as part of disease status monitoring
-had one parent in attendance
Exclusion:
-major affective psychiatric disorders within last 5 years
-concurrent treatment during project with analgesic or psychotropic meds
-no clearly visible veins as judged by nursing performing procedure
-excluded parents if had diagnosis of anxiety or mood disorder or other psychiat
ric
diagnosis in past 5 years
N: 30
Age: 6-14
Gender: M=14, f=16
Diagnosis: Paediatric outpatients
Setting: haematology/oncology clinic of hospital
Interventions 1. EMLA + Hypnosis (n = 15): The hypnosis session included an indu
ction which was
adapted according to the child's age, interests and cognitive and social developme
nt.
References to patient well-being, strengths, competence, and comfort were also i
ncluded
in the inductions. Following several minutes of hypnotic involvement, the patien
t was
given analgesic suggestions, including request for numbness, topical anaesthesia,
local
anaesthesia, glove anaesthesia, and switchbox - Please see above descriptions fo
r other
studies by same authors (e.g., Liossi 2003., Liossi 2006) for more information a
bout
these components. The session ended with a post-hypnotic suggestion that the hyp
notic
experience would be repeated and provide comfort during the actual medical proce
dure
when the parent would stroke the child's hand not receiving the venepuncture. It w
as
alsomentioned that in the future, the application of EMLA 60 min before the LP w
ould
be an additional cue for the child to start relaxing and feeling calm and ready
for the
procedure to follow. Following that, children in the EMLA +Hypnosis group were t
aught
self-hypnosis following an abbreviated version of Gardner's model
2. EMLA + Attention (n = 15): The attention control procedure was similarly base
d
on manuals developed in our previous studies. Patients in the attention control
group
spent identical amount of time with the therapist as did patients in the hypnosi
s group,
to control for professional attention. However, the therapist did not lead the a
ttention
control patients in imagery, relaxation, or other coping skills. Rather, the the
rapist developed
rapport with the patient and engaged in nonmedical verbal interactions about
topics such as extracurricular activities, school, and sports
Both the hypnosis and attention control sessions were delivered to patients indi
vidually
by the same therapist according to the study protocol manual and were standardiz
ed to
last 15 min
3. EMLA only (n = 15): Treated only with EMLA cream applied to the intact skin f
or
approximately 60 minutes before the procedure. The other two groups also receive
d the
same EMLA application
Outcomes 1. Self-Report 100mm VAS pain (range 0-10)
2. Self-Report 100mm VAS of needle-related anxiety
3. Behavioural Measure of Distress: Procedure Behavior Checklist (PBCL)
4. Parent Self-Reported Anxiety using 100mm VAS (i.e., parents rated their own a
nxiety)
Notes The study involved 3 time points (Time 1, Time 2, and Time 3) but we only
included
Time 1 which occurred during the venepuncture and closest to the intervention. T
imes
2 and 3 were 3 and 6 months after the initial session and did not involve therap
ist-led
intervention; therefore, they were not included in this review. Also, we used a
total N
of 30 for this study (instead of 45) because we only assessed 2/3 conditions (EM
LA +
Hypnosis versus EMLA + Attention)
Risk of bias
bias)
Low risk p.256 Par 4 randomly allocated using computer-
generated random positive integers
Allocation concealment (selection bias) High risk Used an open random allocation
schedule
p.256 par 11
All outcomes
rmit judgment
affect outcomes
(performance bias)
All outcomes
bias)
All outcomes
McCarthy 2010
Methods Allocation: randomly assigned
Participants Needle Procedure: IV needle insertion
Inclusion:
-4-10 years of age undergoing a scheduled IV needle insertion for a diagnostic m
edical
procedure
Exclusion:
-developmental disabilities
-limited English language skills to answer study questions
-children with cancer
N: 542
Age: 4-10
Gender: F=262, M=280
Diagnosis: gastro clinic (45%), nephrology (17%), endocrinology (12%), pulmonary
(8%), cardiology (3%), 12% from other clinics (primarily radiology)
Setting: 3 Midwestern children's hospitals
Interventions 1. Parent Distraction Coaching Training (n = 293): In this conditi
on, one parent was
asked to volunteer to be the child's main support person (coach) in the treatment
room
during the IV procedure. The designated parent received the multifaceted 15-min
intervention
on how to provide distraction coaching, which included educational materials,
a video, and discussion with a research assistant. The parent and child then sel
ected
distracters such as books, toys, and video games. Questions were answered, and p
ractice
with the distracters was encouraged
2. Routine Care Control (n = 249): Families randomized to the control group rece
ived
routine care in the clinic, and the parent was encouraged to do whatever he or s
he
normally did to help the child during amedical procedure.Distraction items were
clearly
visible in the treatment room and available to the parent, but there was no dire
ction to
use them
Outcomes Pain:
Self-report: Oucher
Anxiety/Stress:
Caregiver/parent: Parent report of child distress using 1-item from the percepti
on of
procedures questionnaire (how stressed was your child today during the IV procedu
re?
McCarthy 2010 (Continued)
)
Observational: OSBD-R -higher score = more distress, videotaped and coded later
Physiology: salivary cortisol, measured by % change in cortisol levels between th
e
matched clinic and baseline cortisol levels
Notes None
Risk of bias
bias)
Unclear risk Insufficient information to permit judgment of 'low'
or 'high' risk
permit judgment of 'low'
or 'high' risk
All outcomes
High risk Considerable variation in numbers of missing data
across outcomes; reasons not provided
are reported incompletely
Other bias High risk Had a potential source of bias likely to influence outcome
(e.g., control group contamination p.137)
(performance bias)
All outcomes
High risk Although authors report blinding of personnel, parents
aware of group assignment
bias)
All outcomes
High risk No blinding of parent-reported outcome assessment
Nguyen 2010
Methods Allocation: randomization was carried out using opaque envelope, half of
which contained
a paper that said music and half that said no music
Participants Needle procedure: lumbar puncture
Inclusion:
-children with leukaemia
-aged 7-12 years
-were due to undergo LP at oncology ward at NHP, Hanoi
Exclusion:
-significant hearing or visual impairments
-cognitive disorder
N: 40
Nguyen 2010 (Continued)
Age: 7 to12
Gender: F=15, M=25
Diagnosis: children with leukaemia
Setting: Hospital/oncology ward. NHP, Hanoi, Vietnam
Interventions 1. Music (n = 20): Music via earphones. Children chose songs they
liked (traditional
Vietnamese songs and children's songs) played into earphones from an iPod R (porta
ble
music player with earphones)
2. Control (n = 20): Earphones without music were used.
All the children were given identical pre-procedural information about the proce
dures
and the study. The children were instructed on how to use the iPodR before enter
ing
the procedure. In the investigation room, the child put on the earphones and did
or
did not listen to music, according to his/her group, 10 minutes before the LP pr
ocedure
started. At the same time, the physician and nurses washed their hands and prepa
red the
chemotherapy. Apart from the child, the parent, physician, and nurse were presen
t in
the room during the procedure
Outcomes Pain:
Self-ReportNumerical Rating Scale (NRS; range 0-10) administered before, during
and
after LP
Anxiety:
Short form of the Spielberger State-Trait Anxiety Inventory (STAI; range 6-24) a
ssessed
before and after LP
Physiological measures of anxiety:
Heart Rate, Blood Pressure (Systolic and Diastolic), Oxygen Saturation, and Resp
iratory
Rate
Notes Outcomes were assessed at various time points (e.g., before, during, and a
fter procedure)
. For this review, we used 'during' outcomes when available, and when not available,
we
used 'after' outcomes
Risk of bias
bias)
Allocation concealment (selection bias) Low risk Unclear if all appropriate safe
guards taken
with assignment envelopes (i.e. sequentially
numbered or sealed)
All outcomes
rmit judgment
Nguyen 2010 (Continued)
Other bias Unclear risk Potential source of bias related to measurement
of outcomes
(performance bias)
All outcomes
bias)
All outcomes
Noguchi 2006
Methods Allocation: Based on a randomly-generated sequence of numbers
Participants Needle Procedure: at least one of the following injections.. (i.e., i
mmunization(s))
Inclusion:
-between 4-6.5 years old
-would be receiving one or more injections
-were able to comprehend English well enough to understand and complete the focu
s of
attention task
Exclusion:
-none given
N: 62 (final analysis)
Age: 4-6 years old
Gender: F=26, M=38 (not clear if 2 excluded participants were boys or girls)
Diagnosis: Pediatric patients but presumed healthy
Setting: 3 medical clinics, United States
Interventions 1. Musical Story Distraction (n = 21): A focus of attention task w
as designed around a
musical recording for children entitled `Little Squirrel', which contained lyrics th
at told
a story about a little squirrel and the things he did one day. The song was perf
ormed by
a male vocalist and included an instrumental accompaniment
2. Non-Music/Spoken Story Distraction (n = 21): The non-music/spoken version of
the
same story was recited at the same tempo by a male volunteer
Both stories (music and spoken) were recorded onto a CD-R. These selections, eac
h 1
minute and 56 seconds in duration, were presented to the participants via a port
able
CD player and headphones. For the purpose of infection control, the headphones w
ere
wrapped with fresh pieces of plastic wrap each time they were used by a particip
ant.
Visual aids depicting events and characters in the story were created using clip
art. There
were five event visuals: squirrel shaking tail, squirrel wiggling nose, squirrel
digging a
hole, squirrel cracking a nut, and squirrel taking a nap. There were also five a
nimal
character visuals: mouse, owl, rabbit, bee, and dog. Velcro backings were placed
on the
ten laminated visuals, and were presented to the participants on a Velcro board.
The
child was told by the examiner that he/she would be listening to a story about a
little
squirrel who did many things and sawmany animals while he was running around. The
experimenter then labeled the squirrel action visuals one at a time, stating wha
t action
was taking place (e.g., `he shook his tail') and pointing at the corresponding pictu
re on
Noguchi 2006 (Continued)
the Velcro board. The experimenter asked the child to state what was happening i
n each
picture. In situations when the child did not state the action, the experimenter
asked a
yes/no question (e.g., Ìs he wiggling his nose in this picture?') and restated what
action
was taking place. The animal visuals were presented in a similar manner. Childre
n were
told to listen carefully to the story because they would need to point to the va
rious
pictures to answer questions about the story. If the child became distracted fro
m the task
by the injection process, the experimenter attempted to redirect the child to th
e activity
by using phrases such as keep pointing and look at the pictures. In instances when t
he
injection procedure lasted longer than theCDrecording, the recordingwas replayed
.The
child was reinforced by the examiner throughout the procedure for pointing behav
iours
(e.g., Good pointing) and provided with reassurance (e.g., It's almost done. You're
doing a good job) as warranted
3. Standard Care Control (n = 20): When the nurse left the room to prepare the s
yringe
(s), the experimenter and observer positioned themselves in the doorway of the e
xam
room, in an attempt to keep their interactions with the parent/guardian and chil
d to a
minimum
Outcomes Pain:
Self-Report: Faces Pain Scale (FPS)
Nurse/health Professional: FPS (as rated by the experimenter and trained observe
r)
Anxiety/Distress:
Behavioral: Observational Scale of Behavioral Distress (OSBD)
Notes The data for the music and non-music story distraction conditions were poo
led together
to create one overall distraction treatment condition. Outcomes were assessed at
3 time
points or phases (pre-injection, injection, and post-injection). For this review
, we used
data from the injection phase. Also, the distraction conditions included reassur
ance
which has been shown in other studies to be distress promoting
Risk of bias
bias)
Low risk randomly assignedbased on a randomly-
generated sequence of numbers p.
19 Par 1
permit judgment
All outcomes
rmit judgment
Noguchi 2006 (Continued)
(performance bias)
All outcomes
blinded
bias)
All outcomes
Press 2003
Inclusion:
-ages 6-16 years undergoing venepuncture
-conscious
-Hebrew-speaking
-no hearing problems
Exclusion:
-none given
N: 94
Age: 6-16 years
Gender: M = 57, F = 37
Diagnosis: none
Setting: Pediatric EmergencyDepartment of the SarokaUniversityMedicalCenter, Isr
ael
Interventions 1. Uncertainty Reduction + Active Distraction (n = 48): Uncertaint
y reduction: one of
the two attending nurses told the patient: Today you and I will do everything to
make
you feel good during the test. I'll show you how you can help yourself feel good. A
ctive
distraction: the child was shown a pair of headphones, was asked what they were,
was
offered to touch them, and instructed the put them on his/her ears. The child wa
s told
I'll put a song on for you, listen to is until the end, and wait for a question abo
ut it.
This was intended to produce active listening and more cognitive demands during
the
distraction. After hearing the song (and completing the venepuncture) the nurse
asked
the child a question about the song's content (the same question for all children
in the
experimental condition)
2. Usual Care control (n = 46): For both the experimental and control groups, nu
rses
provided usual care for reducing the child's pain and distress (calming words, soo
thing
encouraging parental help, etc)
Outcomes 1. Child self-report of pain during venipuncture using a 10 cm VAS comb
ined with a
faces pain scale
2. Parent and nurse ratings of child pain using the same 10 cm VAS and faces pai
n scale
3. Physicianmeasured pressure/pain threshold of children using a dolorimeter pos
itioned
on 13 points throughout the body
Notes Parent and nurse VAS ratings were pooled together to create one overall 'obs
erver-reported
pain' score. Also, for this review, we classified the treatment condition (Uncer-
Press 2003 (Continued)
tainty Reduction +Distraction) as 'Distraction' because based on the definition desc
ribed
in the study, it did not appear to represent an additional intervention techniqu
e, and
was not overly different from statements made to participants in other distracti
on-based
studies
Risk of bias
bias)
permit judgment
All outcomes
rmit judgment
specific study design (e.g., modified pain
measure)
(performance bias)
All outcomes
blinded
bias)
All outcomes
Sinha 2006
Methods Allocation: randomly assigned by a patient allocation scheme implementin
g a stratified
block design to ensure equal gender
Participants Participants:
Needle Procedure: laceration repair
Inclusion:
-children between 6-18 years of age visiting the EDfor laceration repair between
12noon
and midnight
-had sustained an uncomplicated laceration involving only the skin and subcutane
ous
tissue, <5cm in length which could be repaired using basic suture repair techniq
ues
Exclusion:
-children presenting with multiple lacerations, greater than or equal to 1 compl
ex laceration,
or a laceration associated with other injuries
Sinha 2006 (Continued)
-patients who were unable to understand or fully participate in the informed con
sent
process or study protocol, for whatever reason
N: 240
Age: 6-18 years
Diagnosis: included only children who sustained an uncomplicated laceration invo
lving
only the skin and subcutaneous tissue, <5cm in length, only single laceration in
cluded
Setting: Hospital (emergency department)
Interventions 1. Distraction (n = 120): Children were given a choice of age-appr
opriate distractors
including music, video games, or cartoon video. For children who did not show in
terest
in any of these distractors, a certified child life worker offered to read a boo
k or help
blow bubbles during the procedure. A CD player with headphones was provided for
those selecting music distraction, and subjects were given a choice of music. Ch
ildren in
this group received distraction plus the standard care received in the control g
roup
2. Standard Care Control (n = 120): To minimize compensatory rivalry and resentf
ul
demoralization in the control group, time allocated to patients was identical re
gardless of
study group assignment.The experienced EDchild life staff explained to children
in both
groups what he or she might experience during the procedure by using development
ally
appropriate words and in a non-threatening manner
Outcomes Pain:
Self-report: 7pt Facial Pain Scale
Anxiety/Distress:
Self-Report: State Trait Anxiety Inventory for Children (STAIC) was only adminis
tered
to children over the age of 10 years. It distinguishes between transitory anxiet
y (state
anxiety) and general anxiety proneness (trait anxiety). In this study, the state
anxiety scale
was used to measure situational anxiety in children before and after laceration
repair
Caregiver/Parent report:100-mmVAS to measure pain distress (range: no distress-m
ost
distress). Before and after laceration repair
Notes SDs were not reported in the paper.However,we were able to calculate SDs f
romthe data
available, and these SDs were used in the data analyses. Although the STAIC outc
ome
was only used with children 10 years and older rather than the full sample, we s
till
included this data in our analyses
Risk of bias
bias)
safeguards taken
with assignment envelopes (i.e., opaque)
All outcomes
Low risk Reported missing data did not impact outcomes
Sinha 2006 (Continued)
Selective reporting (reporting bias) Low risk Insufficient information to permit
judgment
heightened awareness of distraction techniques
amongst ED personnel p. 1167)
(performance bias)
All outcomes
bias)
All outcomes
High risk No blinding of self-report and parent-report
outcome assessment
Tak 2006
Inclusion:
-Dutch patients receiving a venepuncture
Exclusion:
-children of non-Dutch parentage
N: 94
Age: 3-12 years (mean = 6.4, SD = 2.5)
Gender: M = 73, F = 63
Diagnosis: none
Setting: outpatient centre of the StAntoniusZiekenhuis inNieuwegein (theNetherla
nds)
Interventions Definitions for the following condition components are provided be
low
1. Placebo, Distraction, Information (n = 20)
2. EMLA, Distraction, Information (n = 21)
3. Placebo, Information (n = 20)
4. EMLA, Information (n = 21)
5. Information (n = 26)
6. Non-Treatment Control (n = 28)
Distraction: During the venepuncture, a funny 6-minute fragment of a video carto
on
(Walk Disney's 'The Beauty and the Beast') was shown. Sound could be heard through
a headphone
Procedural Information: All children except those in the control groups received
information
on the venepuncture by means of a photo book. The supervising research assistant
asked the child to read the book with his/her parent(s) while in the waiting roo
m.
The 24 photos, each accompanied by a short and simple text, showed step by step
what
was to come from entrance to departure from the hospital. A boy 8 years old acte
d as
the model
EMLA: Eutectic mixture of local anaesthetics (EMLA) cream was applied by the lab
o-
Tak 2006 (Continued)
ratory personnel on duty who did not know whether the cream was EMLA or a placeb
o
type of cream. These were not necessarily the same persons as those who did the
pricking
Placebo: A placebo cream was applied by the laboratory personnel on duty who did
not know whether the cream was EMLA or a placebo type of cream. These were not
necessarily the same persons as those who did the pricking
*Because EMLA requires 1 hour to produce its effect, the children in the four `cre
am
conditions' passed that time in the waiting room in the presence of their parent(s
)
Non-Treatment Control: No treatment provided.
Outcomes 1. Child self-reported pain using the Oucher scale for children younger
than 6 years,
and the VAS which children of 6 and over - a research assistant administered the
se scales
immediately after the venepuncture
2. Research assistant ratings of child distress using the Groningen Distress Sca
le (GDS)
, a 5-point categorical behavioral observation scale of distress based on three
categories:
breathing, crying, and muscle tone - scored at three time points (when child ent
ered
room, just before venepuncture, and during venepuncture)
Notes We used a total N of 94 for this study (instead of 136) because we only as
sessed 4/
6 conditions (i.e., Placebo, Distraction, Information versus Placebo, Informatio
n and
Information versus Non-Treatment Control). Although GDS ratings were calculated
at
three time points in this study (child entering the room, just before venepunctu
re, and
during venepuncture), we only used the 'during venepuncture' scores in the analyses
for
this review
Risk of bias
bias)
permit judgment
All outcomes
Unclear risk No reasons for missing data provided
rmit judgment
(performance bias)
All outcomes
blinded
Tak 2006 (Continued)
bias)
All outcomes
Tyc 1997
Participants Needle Procedure: IV insertion prior to MRI
Inclusion:
- ages 6-18 years old and English-speaking
- scheduled to receive a magnetic resonance imaging (MRI) procedure of the brain
or
spine
- had received at least one prior MRI procedure at St Jude's Children's Hospital wit
hin
the last 12 months
-in remission or had stable disease, or both
Exclusion:
- patients who had relapsed or had evidence of progressive disease or had severe
cognitive
deficits, or both (IQ < 70) based on medical chart review, psychosocial historie
s, or
available psychological assessment data
N: 55
Age: 6.3-18.6 years (mean = 12.5 years)
Gender: M = 50.9%, F = 49.1%
Diagnosis: Approximately 27% = medulloblastoma, 24% = CNS glioma, and 49% =
variety of malignant CNS neoplasms
Setting: St Jude's Children's Hospital, Tennessee
Interventions 1. Cognitive-Behavioural Treatment (CBT) (n = 28): The CBT interve
ntion consisted
of a package of five components including: (a) filmed modelling (two age appropr
iate
versions of a 15-minute film that depicted the steps involved in preparation of
the MRI
procedure), (b) breathing exercises (patients learned both passive and active br
eathing
exercises as modeled in the film such as instructions to breathe at a slower tha
n normal
rate while focusing on rhythmic breathing), (c) emotive imagery/distraction (foc
us on
emotive images including heroes like Superman or pleasant mental images like beach
es
that were incompatible with distress), (d) behavioral rehearsal (involved two ta
sks including
practice for starting and IV and an MRI simulation task that provided the opport
unity
to lie still inside the MRI), and (e) positive incentive (showing the child a
small trophy and saying he/she could win the trophy by doing the best they could
do)
2. Standard Care Control (SCC) (n = 27): Prior to their procedures, patients in
this
group had the opportunity to discuss details about the MRI procedure with the MR
I
technologist and also view the magnet. This is the standard preparation for the
MRI
exam at this institution. Patients did not, however, receive additional interven
tion from
the Psychology staff
Outcomes 1. Child self-report of anxiety using the State-Trait Anxiety Inventory
for Children
(STAI-C)
2. Child, parent, and staff ratings of child IV distress
3. Chid, parent, and staff ratings of child MRI distress
Tyc 1997 (Continued)
4. Staff MRI Distress Ratings
5. MRI Behavior Checklist
Notes Parent and staff IV distress ratings were pooled together to create one ov
erall 'observerreported
distress' outcome. Only outcomes related to the IV (not the MRI) were used
in the analyses for this review. The STAI-C scores were used in this study to as
sess
background variables, therefore they were not included in the analyses for this
review
Risk of bias
bias)
permit judgment
All outcomes
rmit judgment
(performance bias)
All outcomes
bias)
All outcomes
Vessey 1994
Methods Allocation: Randomized - using table of random numbers
Participants Needle Procedure: routine blood draws
Inclusion:
- must have had two or fewer blood draws in the six months preceding the procedu
re
- free of chronic conditions
- fluent in English
Exclusion:
- none given
N: 100
Age: 3.6-12.11 years (mean = 7.4 years, SD = 3.3 months)
Vessey 1994 (Continued)
Gender: M = 62%, F = 38%
Diagnosis: none
Setting: Ambulatory Care Clinics of a children's hospital in the south central Uni
ted
States
Interventions 1. Distraction (n = 50). Subjects were given the Illusion Kaleidos
cope to look through
during the blood draw. This toy was selected since it requires no manipulation t
o change
images; rather, glitter suspended in a fluid-filled tube (space tube) passes bef
ore the lens
when held to the eye. The subjects were encouraged to concentrate on what they w
ere
seeing by phrases such as, Do you see the different designs?
2. Standard Care Control (n = 50): Subjects received standard preparation that c
onsisted
of being comforted by physical touch and soft voices
Outcomes 1. Child self-report of pain using the Wong-Baker FACES Pain Rating Sca
le (FACES)
2. Investigator ratings of child pain using the Children's Hospital of Eastern Ont
ario
Pain Scale (CHEOPS)
Notes The authors found that age was a significant covariate, whereby younger ch
ildren reported
perceiving greater intensities of pain and demonstrated more active observable
behavioural distress to the venepuncture that the older children. They provided
adjusted
means (but not adjusted SDs). Since the adjustedmeans were only slightly differe
nt from
the original means, we used the original means and SDs for the analyses in this
review
Risk of bias
bias)
Low risk subjects were randomly assignedusing a
random number table p.370 Par 10
on schedule
All outcomes
rmit judgment
(performance bias)
All outcomes
blinded
bias)
All outcomes
Vosoghi 2010
Methods Allocation: RCT - convenience sample
Participants Needle Procedure: IV Insertion
Inclusion:
-3-6 years of age
-orientation to time, place and people
-ability to make verbal communication
Exclusion:
-pain, seizure, or any life-threatening condition
-administration of pain killers
-insertion of more than one catheter
-time of attempting to insert the catheter more than 60 seconds
N: 72
Age: 3-6 years old
Gender: F=35, M=37
Diagnosis: 57 patients with a diagnosis of infectious diseases and 15 with a dia
gnosis of
internal medicine diseases. No healthy children
Setting: Emergency department of a children's hospital
Interventions 1. Distraction (n = 36): Two minutes before the IV insertion, dist
raction was done using
a bubble maker (i.e., a train that whistles and makes bubbles while moving) and
was
continued until the end of the procedure
2. Control (n = 36): Same overall study procedure for all participants (e.g., he
art rate and
oxygen saturation were assessed 3 minutes after the catheter was fixed, pain ass
essment
was completed 10minutes after catheterization), but in this control group, no di
straction
was administered
Outcomes Pain:
Self-Reported: OUCHER - was done 20 min after the procedure
Physiological measures:
Heart rate (pre/post-intervention), Oxygen Saturation (pre/post-intervention)
Notes This was an article in Farsi and we had a translator help us with data ext
raction. For study
exclusion criteria, the authors did not explain what they meant by 'pain' but presum
ably
this was pain not explicitly due to the needle procedure. In addition, althoughm
eans and
SDs for the OUCHER were not reported in the paper, these were obtained via conta
ct
with the study authors
Risk of bias
bias)
permit judgment
Vosoghi 2010 (Continued)
All outcomes
judgment of 'low' or 'high' risk
Selective reporting (reporting bias) High risk One ormore outcomes of interest a
re reported
incompletely to include in meta-analyses
Other bias Unclear risk Insufficient information to assess whether an
important risk of bias exists
(performance bias)
All outcomes
High risk Nomention of blinding but nature of psychological
intervention precludes this
bias)
All outcomes
Wang 2008
Methods Allocation: according to random numbers from 1-300 by research randomize
r
Inclusion:
-8-9 years old requiring initial venepuncture for a period of intravenous treatm
ent in the
paediatric department
Exclusion:
-history of puncture during the past 3 months
-treatment with anxiolytic or narcotic analgesics medication 72h prior to the ve
nepuncture
-presence of insufficient mental development, alteration of mental status and co
gnitive
impairment
-visual and auditory deficits
N: 300
Age: 8-9 years old
Diagnosis: pneumonia, asthma, encephalitis, allergic purpura
Setting: pediatric department in hospital, China
Interventions 1. Audiovisual Distraction (n = 100): Patients were given a choice
of 10 appropriate
cartoon videos. A TV set coupled with a DVD player was provided for patients to
play
their favourite animated cartoons. During the showing of the cartoon films (abou
t three
minutes after the film began), venepuncture was performed by a registered nurse
2. Psychological Interventions (n = 100): Patients received conventional psychol
ogical interventions
in a fixed scheme delivered by a research nurse (e.g., comfort provided, procedu
re
explained, therapeutic touch, guided imagery, and encouragement) with no audiovi
sual
distraction. The intervention methods, including explaining before venepuncture,
therapeutic touch, encouragement and guided imagery during the procedure, were a
ctualized
by utilizing developmentally appropriate words and in a non-threatening manner
Wang 2008 (Continued)
3. Control Condition (n = 100): Patients underwent venepuncture without any spec
ial
intervention (i.e., no audiovisual distraction or psychological interventions)
Outcomes 1. Self Report Pain: 10 cm Visual Analogue Scale (VAS)
2. Cooperative Behaviour Scale of Children in Venepuncture (CBSCV): Scale create
d
by authors and used by research nurses to evaluate the cooperation of children i
n the
three groups
Notes None
Risk of bias
bias)
Low risk randomly assignedaccording to random
numbersgenerated for Research Randomizer
p. 580 Par 6
safeguards taken
with assignment envelopes (i.e., opaque)
All outcomes
rmit judgment
Other bias High risk Had a potential source of bias related to significantly
different to length of procedure
time (p.581)
(performance bias)
All outcomes
blinded
bias)
All outcomes
Windich-Biermeier 2007
Methods Allocation: randomly assigned using an SPSS pseudo-random number generato
r
Participants Needle Procedure: venous port access or venepuncture
Inclusion:
-5-18 years old
-able to understand and speak English
-able to hear and see
Windich-Biermeier 2007 (Continued)
-had a diagnosis of leukaemia, lymphoma, a solid tumor, or histiocytosis
-were receiving chemotherapy
-had a physician's order for a port access/venepuncture
-had at least one previous access/venepuncture
Exclusion:
-youth with cancer excluded if theywere septic, dehydrated, vomiting, sedated,me
dically
unstable, diagnosed with mental illness, or scheduled for another procedure foll
owing
the port access/venepuncture
N: 50
Age: 5-18 years old
Gender: F=23, M=27
Diagnosis: cancer
Setting: Hospital - University affiliated regional, paediatric medical centre
Interventions 1. Parent Coaching + Child Distraction (n = 22): In addition to st
andard care, the
intervention group also used a self-selected distracter. Participants chose one
from a pool
of five distracters including: (a) the I Spy SuperChallenger bookwhere parents a
sked their
child to look for hidden pictures or items on the page among various graphic des
igns, (b)
bubbles (parents below bubbles using amagic wand, (c)music table (vibroacoustic
music
felt through speakers built into the mattress of the procedure table; sound is h
eard via
speakers and also channeled through headphones; children selected a 45-minute mu
sic
CD of music from Radio Disney-Kid Jams and other children's classics), (d) Virtual
Reality glasses (similar to oversized sunglasses with attached earphones, showin
g a 3D
videowith stereo-soundmusic), and (e)NintendoGameboy (handles gaming devicewith
colour screen displaying fast-moving action packed games with sound effects). Af
ter the
participant selected a distracter, the parent was instructed by one of the co-in
vestigators
using a standardized script, to actively coach the child to use the distraction
item.During
the procedure, the participants were repeatedly encouraged by their parents to f
ocus all
of their attention on the distracter instead of the procedure. Just prior to beg
inning the
procedure and during the procedure, the parent provided constant and repeated ve
rbal
distraction cues to the patient (e.g., Help me find the rabbits on this page, Can y
ou
count the number of bubbles in the air?, etc)
2. Standard Care (n = 28): The comparison group received standard care including
:
(a) a full explanation of the procedure given to the participant and parent, (b)
parental
presence at the participant's side during the procedure for support, and (c) use o
f a topical
anesthetic over the needle puncture site (either EMLA or Fluori-Methane, dependi
ng
on participant/parent preference), which is the standard practice for all non-em
ergent
needle stick procedures)
Outcomes Self Report:
Pain: Color Analogue Scale (bottom narrow/no pink color -> no pain/hurt/top wide
,
very red -> worst pain/hurt)
Anxiety/Distress:
Self Report: Glasses Fear Scale (a type of VAS to asses fear) - empty cylinder =
no fear,
filled cylinder = worst fear
Caregiver/Parent report: assessed child's fear pre and post-procedure
Nurse/Health professional report: assessed child's fear pre and post-procedure
Behavioural Measure of Distress:
Observation Scale of Behavioral Distress (OSBD) assessed by nurse pre and post-p
roce-
Windich-Biermeier 2007 (Continued)
dure
Other Outcome(s):
Investigator-developed IV Poke Questionnaire (IPQ) used by nurse to interview pa
rticipants
(IPQ-Subject) and their parents (IPQ-Parent) about their experiences during the
port access/venepuncture
Notes Data for parent-reported fear, nurse-reported fear, and OBSD broken down b
y group
(intervention versus control) were not reported, and therefore could not be incl
uded
in the analyses for this review. Also, although the authors label the interventi
on as
distraction, they describe it as involving distraction with parent coaching. There
fore,
we classified it in the 'Parent Coaching + ChildDistraction' intervention category f
or this
review. Lastly, the intervention and control groups differed in terms of various
variables
(e.g., type of topical analgesic used, parental presence, number of cannulation
attempts)
; however, there were no statistically significant differences between the group
s on any
of these variables
Risk of bias
bias)
Low risk randomly assigned using an SPSS pseudorandom
number generator (p.9)
permit judgment
All outcomes
are reported
incompletely
(performance bias)
All outcomes
blinded
bias)
All outcomes
Wint 2002
Participants Needle Procedure: lumbar puncture (LP)
Inclusion:
- between the ages of 10-19 years being treated for cancer
- receiving LPs as part of therapy and undergoing at least a second LP
- all ethnicities, and able to understand and communicate in English
- able to hear and see
Exclusion:
- none given
N: 30
Age: 10-19 years
Gender: M = 16, F = 14
Diagnosis: Acute Lymphoblastic Leukaemia = 20, B-cell Lymphoma = 1, Lymphoma =
1, T-cell = 2, T-cell ALL = 4, T-cell Lymphoma = 2
Setting: private, in-hospital clinic treatment room within a 322-bed paediatric
teaching
hospital in the southwest United States
Interventions 1. Virtual Reality (VR) Distraction (n = 17): Adolescents in this
wore VR glasses during
their LPs, in addition to receiving standard nursing care. The glasses were simi
lar to
oversized sunglasses with earphones attacked. Subjects were placed in the standa
rd side
lying position for their LPs with a videocassette recorder/television placed at
eye level.
They all watched the same video through the glasses, which provided 3D viewing,
and
listened tomusic in stereo sound. The VR video entitled Èscape' included 64minutes
of
footage and contained experiences of skiing down the Swiss Alps, explosive drag
racing,
a stroll down Paris sidewalks, and visions of quiet mountain streams. Prior to c
onscious
sedations, nurses used a standardized script to explain the purpose of the VR gl
asses to
subjects and the need to focus their attention on what they were hearing and see
ing
instead of on the discomfort of the procedure. The subjects started watching the
video
when placed on the procedure table at the beginning of the LP and finished when
the
sedation recovery criteria were met
2. Standard Care Comparison (n = 13): Adolescents in this group received standar
d
nursing care for an LP including: (a) weight-based conscious sedations using Fen
tanyl
and Midazolam, (b) 2.5 grams of EMLA cream applied at the spinal injection site,
(c) a
full explanation of the LP given to them and their parent, and (d) parental pres
ence at
their patient's side for support. Although subjects received sedation, theywere co
gnitively
aware of the environment and able to respond, move, and verbalize discomfort and
anxiety during the LP
Outcomes 1. Child/Adolescent self-report of pain using 100 mm vertical VAS
2. Nurse ratings of child's sedation level following the LP using the Sedation Ass
essment
Scale
3. Investigator developed ten-item questionnaire completed by the children/adole
scents
to determine their experiences during the LP in both groups, and the subjective
experience
of the VR glasses by those in the experimental group
Notes None
Risk of bias
Wint 2002 (Continued)
bias)
permit judgment
All outcomes
are reported
incompletely
small and unequal sample size)
(performance bias)
All outcomes
blinded
bias)
All outcomes
Characteristics of excluded studies [ordered by study ID]
Study Reason for exclusion
Agarwal 2008 Older than included age range/adult sample
Alavi 2005 Cross-over design with data not available pre-crossover
Alderfer 2010 Inappropriate outcome measures/outcomes not related to pain or anx
iety
Alhani 2010 Not a randomized controlled trial/reported assignment not truly rand
om/quasi-randomized assignment
Anghelescu 2013 Intervention not primarily psychological
Anson 2010 Older than included age range/adult sample
Arts 1994 Met inclusion criteria but missing data necessary for pooling such as
means, standard deviations, and/or cell
sizes
(Continued)
Ashkenzai 2006 Not a randomized controlled trial/reported assignment not truly r
andom/quasi-randomized assignment
Atkinson 2009 Not a randomized controlled trial/reported assignment not truly ra
ndom/quasi-randomized assignment
Bagnasco 2012 Not a randomized controlled trial/reported assignment not truly ra
Baxter 2011 Inappropriate intervention/cannot isolate effects of psychological c
omponents from multi-component intervention
Bengston 2002 Met inclusion criteria but missing data necessary for pooling such
as means, standard deviations, and/or cell
sizes
Berberich 2009 Only one group received an adjunct pharmacological intervention
Boivin 2008 Not a randomized controlled trial/reported assignment not truly rand
Bowen 1999 Failed randomization
Broome 1998 No control/comparison group or inappropriate control group
Bruck 1995 Inappropriate outcome measures/outcomes not related to pain or anxiet
y
Bufalini 2009 Use of general anaesthesia/conscious sedation prior to needle proc
edure
Bufalini 2012 Conference presentation abstract/not a published RCT
Carlson 2000 Met inclusion criteria but missing data necessary for pooling such
sizes
Chen 2000b Met inclusion criteria but missing data necessary for pooling such as
sizes
Christiano 1996 Not a randomized controlled trial/reported assignment not truly
random/quasi-randomized assignment
Cline 2006 Not a randomized controlled trial/reported assignment not truly rando
m/quasi-randomized assignment
Cohen 1997 Not a randomized controlled trial/reported assignment not truly rando
Cohen 1999 ?
Cramer-Berness 2005 Younger than included age range/infant sample
(Continued)
Crowley 2011 Not a randomized controlled trial/reported assignment not truly ran
dom/quasi-randomized assignment
Dalhquist 2002 Met inclusion criteria but missing data necessary for pooling suc
h as means, standard deviations, and/or cell
sizes
Dalhquist 2005 Secondary data analysis/original study not included in review
Davit 2011 Not a randomized controlled trial/reported assignment not truly rando
Demir 2012 Intervention not primarily psychological
Drahota 2008 Older than included age range/adult sample
Dufresne 2010 Not a randomized controlled trial/reported assignment not truly ra
El-Sharkawi 2012 Cross-over design with data not available pre-crossover
Fassler 1985 Met inclusion criteria but missing data necessary for pooling such
sizes
French 1994 Not a randomized controlled trial/reported assignment not truly rand
Gilbert 1982 Met inclusion criteria but missing data necessary for pooling such
sizes
Goymour 2000 Met inclusion criteria but missing data necessary for pooling such
sizes
Hatava 2000 Surgical procedure
Hawkins 1998 No control/comparison group or inappropriate control group
Heckler-Medina 2006 Not a randomized controlled trial/reported assignment not tr
uly random/quasi-randomized assignment
Heden 2009 Not a randomized controlled trial/reported assignment not truly rando
Hoffman 2011 Not a randomized controlled trial/reported assignment not truly ran
Howe 2011 Not a randomized controlled trial/reported assignment not truly random
/quasi-randomized assignment
Inal 2010 Met inclusion criteria but missing data necessary for pooling such as
sizes
Jacobson 2006 Older than included age range/adult sample
Jay 1987 Met inclusion criteria but missing data necessary for pooling such as m
eans, standard deviations, and/or cell
sizes
(Continued)
Jay 1990 Inappropriate outcome measures/outcomes not related to pain or anxiety
Jay 1991 Inappropriate intervention/cannot isolate effects of psychological comp
onents from multi-component intervention
Jay 1995 No control/comparison group or inappropriate control group
Kain 2006 Use of general anaesthesia/conscious sedation prior to needle procedur
e
Kammerbauer 2011 Not a randomized controlled trial/reported assignment not truly
random/quasi-randomized assignment
Kazak 1996 Means or standard deviations, or both, not available
Kazak 1998 Met inclusion criteria but missing data necessary for pooling such as
sizes
Kettwich 2007 No needle procedure
Klingman 1985 Met inclusion criteria but missing data necessary for pooling such
sizes
Klorman 1980 Surgical procedure
Kolk 2000 No control/comparison group or inappropriate control group
Krauss 1996 Non-published dissertation study
Kuttner 1988 Met inclusion criteria but missing data necessary for pooling such
sizes
Kwekkeboom 2003 Older than included age range/adult sample
Lawes 2008 Not a randomized controlled trial/reported assignment not truly rando
Lessi 2011 Not a randomized controlled trial/reported assignment not truly rando
Liossi 2007 Not a randomized controlled trial/reported assignment not truly rand
Lustman 1983 Surgical procedure
MacLaren 2005 Not a randomized controlled trial/reported assignment not truly ra
MacLaren 2007 Not a randomized controlled trial/reported assignment not truly ra
Malone 1996 Met inclusion criteria but missing data necessary for pooling such a
s means, standard deviations, and/or cell
sizes
Manimala 2000 Not a randomized controlled trial/reported assignment not truly ra
(Continued)
Manne 1990 Not a randomized controlled trial/reported assignment not truly rando
Manne 1994 Not a randomized controlled trial/reported assignment not truly rando
Marec-Berard 2009 Intervention not primarily psychological
McCarthy 1998 Failed randomization
McCarthy 2010b Results not presented separately as control versus treatment grou
p/secondary analysis and original study
included in review
McInally 2005 Not a randomized controlled trial/reported assignment not truly ra
Megel 1998 Met inclusion criteria but missing data necessary for pooling such as
sizes
Melamed 1974 Surgical procedure
Myrvik 2009 Non-published dissertation study
Nilsson 2009 Not a randomized controlled trial/reported assignment not truly ran
O'Laughlin 1995 Met inclusion criteria but missing data necessary for pooling such
sizes
Olsen 1991 Not a randomized controlled trial/reported assignment not truly rando
Ozdemir 2012 Younger than included age range/infant sample
Park 2008 Intervention not primarily psychological
Pederson 1996 Fewer than five participants per condition
Peretz 1999 Met inclusion criteria but missing data necessary for pooling such a
sizes
Posner 1998 Non-published dissertation study
Powers 1993 Not a randomized controlled trial/reported assignment not truly rand
Ramponi 2009 Not a randomized controlled trial/reported assignment not truly ran
Reeb 1997 Met inclusion criteria but missing data necessary for pooling such as
sizes
Rogovik 2007 Not a randomized controlled trial/reported assignment not truly ran
Russell 2012 Failed randomization
(Continued)
Salih 2010 Older than included age range/adult sample
Santos 1999 Met inclusion criteria but missing data necessary for pooling such a
sizes
Schechter 2010 Not a randomized controlled trial/reported assignment not truly r
andom/quasi-randomized assignment
Schneider 2011 Older than included age range/adult sample
Schur 1986 Not a randomized controlled trial/reported assignment not truly rando
Shabanloei 2010 Older than included age range/adult sample
Shahabi 2007 Cross-over design with data not available pre-crossover
Shimizu 2005 Older than included age range/adult sample
Sikorova 2011 Not a randomized controlled trial/reported assignment not truly ra
Slack 2009 Older than included age range/adult sample
Slifer 2009 No control/comparison group or inappropriate control group
Slifer 2011 Not a randomized controlled trial/reported assignment not truly rand
Smith 1989 No control/comparison group or inappropriate control group
Smith 1996 No control/comparison group or inappropriate control group
Sparks 2001 Not a randomized controlled trial/reported assignment not truly rand
Stefano 2005 Not a randomized controlled trial/reported assignment not truly ran
Stevenson 2005 Inappropriate intervention/cannot isolate effects of psychologica
l components from multi-component intervention
Sury 2010 Not a randomized controlled trial/reported assignment not truly random
Thurgate 2005 Not a randomized controlled trial/reported assignment not truly ra
Tufekci 2009 Not a randomized controlled trial/reported assignment not truly ran
Vernon 1974 Met inclusion criteria but missing data necessary for pooling such a
sizes
Vika 2009 Older than included age range/adult sample
(Continued)
Vohra 2011 Not a randomized controlled trial/reported assignment not truly rando
Wall 1989 No control/comparison group or inappropriate control group
Wallace 2010 Intervention not primarily psychological
Weber 2010 No needle procedure
Weinstein 2003 No needle procedure
Winborn 1989 Surgical procedure
Wood 2002 Not a randomized controlled trial/reported assignment not truly random
Yoo 2011 Not a randomized controlled trial/reported assignment not truly random/
quasi-randomized assignment
Young 1988 Met inclusion criteria but missing data necessary for pooling such as
sizes
Zabin 1982 Non-published dissertation study
Zahr 1998 Not a randomized controlled trial/reported assignment not truly random
Zeltzer 1982 Met inclusion criteria but missing data necessary for pooling such
sizes
D A T A A N D A N A L Y S E S
Comparison 1. Distraction
Outcome or subgroup title
No. of
studies
No. of
participants Statistical method Effect size
1 Self-reported pain 19 1759 Std. Mean Difference (IV, Random, 95% CI) -0.61 [-0
.91, -0.32]
2 Observer-reported pain 5 447 Std. Mean Difference (IV, Random, 95% CI) -0.87 [
-1.75, 0.02]
3 Self-reported distress 3 286 Std. Mean Difference (IV, Random, 95% CI) -0.66 [
-1.37, 0.06]
4 Observer-reported distress 2 363 Std. Mean Difference (IV, Random, 95% CI) -1.
15 [-2.73, 0.42]
5 Behavioral measures- Pain 2 152 Std. Mean Difference (IV, Random, 95% CI) -0.1
5 [-0.69, 0.40]
6 Behavioral measures- Distress 5 254 Std. Mean Difference (IV, Random, 95% CI)
-0.30 [-0.76, 0.16]
7 Physiological measure - Heart
Rate
2 112 Std. Mean Difference (IV, Random, 95% CI) -0.70 [-1.08, -0.32]
8 Physiological measure - Oxygen
Saturation
2 112 Std. Mean Difference (IV, Random, 95% CI) 0.60 [0.22, 0.98]
Comparison 2. Hypnosis
No. of
studies
No. of
1 Self-reported pain 5 176 Std. Mean Difference (IV, Random, 95% CI) -1.40 [-2.3
2, -0.48]
-3.93, -1.12]
-1.15 [-1.76, -0.53]
Comparison 3. Preparation and information
No. of
studies
No. of
0, 0.76]
Comparison 4. Virtual reality
No. of
studies
No. of
, 0.33]
Comparison 5. CBT-combined
No. of
studies
No. of
2, 0.44]
-1.08, 0.07]
3 Observer-reported distress 2 84 Std. Mean Difference (IV, Random, 95% CI) 0.04
[-0.87, 0.95]
-0.54 [-1.16, 0.09]
Comparison 6. Parent coaching + child distraction
No. of
studies
No. of
1 Self-reported pain 3 612 Std. Mean Difference (IV, Random, 95% CI) 0.06 [-0.19
, 0.31]
2 Observer-reported distress 2 581 Std. Mean Difference (IV, Random, 95% CI) -0.
04 [-0.21, 0.12]
-0.36 [-0.97, 0.25]
Comparison 7. Suggestion
No. of
studies
No. of
0, 0.15]
Analysis 1.1. Comparison 1 Distraction, Outcome 1 Self-reported pain.
Review: Psychological interventions for needle-related procedural pain and distr
ess in children and adolescents
Comparison: 1 Distraction
Outcome: 1 Self-reported pain
Study or subgroup Treatment Control
Std.
Mean
Difference Weight
Std.
Mean
Difference
N Mean(SD) N Mean(SD) IV,Random,95% CI IV,Random,95% CI
Balan 2009 50 2.88 (2.26) 50 7.94 (1.68) 5.2 % -2.52 [ -3.05, -1.99 ]
Bellieni 2006 46 13.15 (16.3) 23 23.04 (24.57) 5.3 % -0.50 [ -1.01, 0.00 ]
Caprilli 2007 54 1.81 (0.89) 54 2.33 (1.19) 5.6 % -0.49 [ -0.87, -0.11 ]
Cassidy 2002 31 1.36 (1.39) 28 2.03 (1.9) 5.2 % -0.40 [ -0.92, 0.12 ]
Fanurik 2000 53 22.6 (24.03) 56 27.29 (29.27) 5.7 % -0.17 [ -0.55, 0.20 ]
Fowler-Kerry 1987 40 1.34 (1.14) 80 1.78 (1.14) 5.6 % -0.38 [ -0.77, 0.00 ]
Gonzalez 1993 14 2.86 (1.61) 14 3.29 (1.44) 4.5 % -0.27 [ -1.02, 0.47 ]
Gupta 2006 25 2.36 (1.15) 25 4 (1.32) 4.9 % -1.30 [ -1.92, -0.69 ]
Inal 2012 61 3.9 (1.94) 62 6.51 (1.65) 5.6 % -1.44 [ -1.84, -1.04 ]
Jeffs 2007 19 4.12 (2.01) 8 3.49 (2.05) 4.2 % 0.30 [ -0.53, 1.13 ]
Kristjansdottir 2010 79 0.94 (1.58) 39 1 (0.95) 5.6 % -0.04 [ -0.43, 0.34 ]
Nguyen 2010 20 2.35 (1.9) 20 5.65 (2.5) 4.6 % -1.46 [ -2.16, -0.75 ]
Noguchi 2006 42 3.34 (2.67) 20 3.53 (2.76) 5.2 % -0.07 [ -0.60, 0.46 ]
Press 2003 48 2.8 (2) 46 3.8 (2.9) 5.6 % -0.40 [ -0.81, 0.01 ]
Sinha 2006 120 0.27 (0.74) 120 0.39 (0.74) 6.0 % -0.16 [ -0.42, 0.09 ]
Tak 2006 20 2.58 (1.89) 20 1.85 (1.18) 4.9 % 0.45 [ -0.17, 1.08 ]
Vessey 1994 50 2.18 (1.61) 50 3.23 (1.78) 5.6 % -0.61 [ -1.02, -0.21 ]
Vosoghi 2010 36 2.11 (0.97) 36 4.55 (1.42) 5.1 % -1.99 [ -2.55, -1.42 ]
Wang 2008 100 4.55 (2.26) 100 5.22 (2.53) 5.9 % -0.28 [ -0.56, 0.00 ]
Total (95% CI) 908 851 100.0 % -0.61 [ -0.91, -0.32 ]
Heterogeneity: Tau2 = 0.36; Chi2 = 151.01, df = 18 (P<0.00001); I2 =88%
Test for overall effect: Z = 4.08 (P = 0.000045)
Test for subgroup differences: Not applicable
-4 -2 0 2 4
Favours treatment Favours control
Analysis 1.2. Comparison 1 Distraction, Outcome 2 Observer-reported pain.
Outcome: 2 Observer-reported pain
Std.
Mean
Difference Weight
Std.
Mean
Difference
Balan 2009 50 3.09 (1.96) 50 7.75 (1.75) 19.7 % -2.49 [ -3.02, -1.96 ]
Bellieni 2006 46 17.61 (15.58) 23 21.3 (19.9) 19.9 % -0.21 [ -0.71, 0.29 ]
Inal 2012 61 3.83 (2.19) 61 6.43 (1.61) 20.4 % -1.34 [ -1.74, -0.95 ]
Noguchi 2006 42 3.74 (2.02) 20 4.53 (2.09) 19.7 % -0.38 [ -0.92, 0.16 ]
Press 2003 48 3.25 (2) 46 3.1 (2.08) 20.3 % 0.07 [ -0.33, 0.48 ]
Total (95% CI) 247 200 100.0 % -0.87 [ -1.75, 0.02 ]
-100 -50 0 50 100
Analysis 1.3. Comparison 1 Distraction, Outcome 3 Self-reported distress.
Outcome: 3 Self-reported distress
Std.
Mean
Difference Weight
Std.
Mean
Difference
Fanurik 2000 56 35.5 (30.1) 59 35 (29.8) 35.6 % 0.02 [ -0.35, 0.38 ]
Nguyen 2010 20 8.1 (2.22) 20 13 (4.17) 28.5 % -1.44 [ -2.14, -0.73 ]
Sinha 2006 68 26.72 (5.44) 63 30.41 (4.99) 35.8 % -0.70 [ -1.06, -0.35 ]
Total (95% CI) 144 142 100.0 % -0.66 [ -1.37, 0.06 ]
Heterogeneity: Tau2 = 0.34; Chi2 = 15.72, df = 2 (P = 0.00039); I2 =87%
-4 -2 0 2 4
Analysis 1.4. Comparison 1 Distraction, Outcome 4 Observer-reported distress.
Outcome: 4 Observer-reported distress
Std.
Mean
Difference Weight
Std.
Mean
Difference
Inal 2012 61 1.38 (0.89) 62 3.33 (1.07) 49.4 % -1.97 [ -2.40, -1.53 ]
Sinha 2006 120 0.57 (0.98) 120 1.02 (1.46) 50.6 % -0.36 [ -0.62, -0.11 ]
Total (95% CI) 181 182 100.0 % -1.15 [ -2.73, 0.42 ]
-4 -2 0 2 4
Analysis 1.5. Comparison 1 Distraction, Outcome 5 Behavioral measures- Pain.
Outcome: 5 Behavioral measures- Pain
Std.
Mean
Difference Weight
Std.
Mean
Difference
Cassidy 2002 27 5.16 (2.67) 25 4.69 (2.96) 44.2 % 0.16 [ -0.38, 0.71 ]
Vessey 1994 50 7.76 (2.5) 50 8.73 (2.38) 55.8 % -0.39 [ -0.79, 0.00 ]
Total (95% CI) 77 75 100.0 % -0.15 [ -0.69, 0.40 ]
-1 -0.5 0 0.5 1
Analysis 1.6. Comparison 1 Distraction, Outcome 6 Behavioral measures- Distress.
Outcome: 6 Behavioral measures- Distress
Std.
Mean
Difference Weight
Std.
Mean
Difference
Caprilli 2007 54 6.8 (7.5) 54 13.5 (9.7) 26.8 % -0.77 [ -1.16, -0.38 ]
Gonzalez 1993 14 4.84 (1.46) 14 5.81 (1.2) 17.2 % -0.70 [ -1.47, 0.06 ]
Kuttner 1987 8 13.8 (4.4) 8 9.1 (5.5) 12.2 % 0.89 [ -0.15, 1.93 ]
Noguchi 2006 42 3.32 (2.86) 20 3.98 (3.51) 23.0 % -0.21 [ -0.75, 0.32 ]
Tak 2006 20 2.67 (0.94) 20 2.83 (1.02) 20.7 % -0.16 [ -0.78, 0.46 ]
Total (95% CI) 138 116 100.0 % -0.30 [ -0.76, 0.16 ]
-4 -2 0 2 4
Analysis 1.7. Comparison 1 Distraction, Outcome 7 Physiological measure - Heart
Rate.
Outcome: 7 Physiological measure - Heart Rate
Std.
Mean
Difference Weight
Std.
Mean
Difference
Nguyen 2010 20 102.7 (9.24) 20 117.7 (19.49) 33.9 % -0.96 [ -1.62, -0.31 ]
Vosoghi 2010 36 124.87 (20.1) 36 137.2 (22.98) 66.1 % -0.57 [ -1.04, -0.09 ]
Total (95% CI) 56 56 100.0 % -0.70 [ -1.08, -0.32 ]
Heterogeneity: Tau2 = 0.0; Chi2 = 0.93, df = 1 (P = 0.33); I2 =0.0%
-100 -50 0 50 100
Analysis 1.8. Comparison 1 Distraction, Outcome 8 Physiological measure - Oxygen
Saturation.
Outcome: 8 Physiological measure - Oxygen Saturation
Std.
Mean
Difference Weight
Std.
Mean
Difference
Nguyen 2010 20 99.2 (1.14) 20 98 (2.77) 35.9 % 0.56 [ -0.08, 1.19 ]
Vosoghi 2010 36 97.22 (1.65) 36 95.59 (3.25) 64.1 % 0.63 [ 0.15, 1.10 ]
Total (95% CI) 56 56 100.0 % 0.60 [ 0.22, 0.98 ]
-100 -50 0 50 100
Analysis 2.1. Comparison 2 Hypnosis, Outcome 1 Self-reported pain.
Comparison: 2 Hypnosis
Std.
Mean
Difference Weight
Std.
Mean
Difference
Katz 1987 17 55 (36.9) 19 51.81 (33.8) 21.4 % 0.09 [ -0.57, 0.74 ]
Liossi 1999 10 1.9 (0.99) 10 4.2 (0.63) 16.5 % -2.65 [ -3.92, -1.39 ]
Liossi 2003 40 1.95 (1.3) 20 4.3 (0.6) 21.4 % -2.07 [ -2.73, -1.41 ]
Liossi 2006 15 1.27 (0.8) 15 2.67 (1.05) 20.2 % -1.46 [ -2.28, -0.64 ]
Liossi 2009 15 2.74 (0.83) 15 4.17 (1.44) 20.5 % -1.18 [ -1.97, -0.40 ]
Total (95% CI) 97 79 100.0 % -1.40 [ -2.32, -0.48 ]
-4 -2 0 2 4
Analysis 2.2. Comparison 2 Hypnosis, Outcome 2 Self-reported distress.
Std.
Mean
Difference Weight
Std.
Mean
Difference
Katz 1987 17 4.8 (1.9) 19 5.2 (1.4) 21.7 % -0.24 [ -0.89, 0.42 ]
Liossi 1999 10 0.9 (1.1) 10 4.6 (0.52) 17.2 % -4.12 [ -5.79, -2.45 ]
Liossi 2003 40 1.45 (1.4) 20 4.4 (0.6) 21.5 % -2.43 [ -3.13, -1.73 ]
Liossi 2006 15 0.4 (0.63) 15 2.13 (0.74) 20.5 % -2.45 [ -3.43, -1.47 ]
Liossi 2009 15 2.35 (0.52) 15 4.17 (0.38) 19.1 % -3.89 [ -5.16, -2.61 ]
Total (95% CI) 97 79 100.0 % -2.53 [ -3.93, -1.12 ]
-10 -5 0 5 10
Analysis 2.3. Comparison 2 Hypnosis, Outcome 3 Behavioral measures- Distress.
Std.
Mean
Difference Weight
Std.
Mean
Difference
Katz 1987 17 6.6 (3.3) 19 7.3 (3.4) 18.8 % -0.20 [ -0.86, 0.45 ]
Kuttner 1987 9 8.2 (3.7) 8 9.1 (5.5) 15.2 % -0.18 [ -1.14, 0.77 ]
Liossi 1999 10 5.1 (4.41) 10 12.6 (3.83) 13.9 % -1.74 [ -2.80, -0.68 ]
Liossi 2003 40 8.3 (5.7) 20 16 (4.8) 19.5 % -1.40 [ -2.00, -0.81 ]
Liossi 2006 15 7.4 (3.22) 15 13.33 (2.79) 16.0 % -1.92 [ -2.80, -1.03 ]
Liossi 2009 15 5.07 (0.59) 15 6.3 (0.91) 16.6 % -1.56 [ -2.39, -0.73 ]
Total (95% CI) 106 87 100.0 % -1.15 [ -1.76, -0.53 ]
-4 -2 0 2 4
Analysis 3.1. Comparison 3 Preparation and information, Outcome 1 Self-reported
pain.
Comparison: 3 Preparation and information
Std.
Mean
Difference Weight
Std.
Mean
Difference
Harrison 1991 50 2 (1.73) 50 3.06 (1.22) 51.6 % -0.70 [ -1.11, -0.30 ]
Tak 2006 26 2.82 (1.76) 28 2.3 (1.66) 48.4 % 0.30 [ -0.24, 0.84 ]
Total (95% CI) 76 78 100.0 % -0.22 [ -1.20, 0.76 ]
-4 -2 0 2 4
Analysis 4.1. Comparison 4 Virtual reality, Outcome 1 Self-reported pain.
Comparison: 4 Virtual reality
Std.
Mean
Difference Weight
Std.
Mean
Difference
Gold 2006 10 1.9 (2.36) 10 2.2 (1.98) 40.7 % -0.13 [ -1.01, 0.75 ]
Wint 2002 17 12.41 (13.57) 13 17.23 (18.67) 59.3 % -0.29 [ -1.02, 0.43 ]
Total (95% CI) 27 23 100.0 % -0.23 [ -0.79, 0.33 ]
-100 -50 0 50 100
Analysis 5.1. Comparison 5 CBT-combined, Outcome 1 Self-reported pain.
Comparison: 5 CBT-combined
Std.
Mean
Difference Weight
Std.
Mean
Difference
Bisignano 2006 14 20.93 (33.08) 16 10.44 (15.94) 33.8 % 0.40 [ -0.32, 1.13 ]
Liossi 1999 10 2.7 (0.67) 10 4.2 (0.63) 26.8 % -2.21 [ -3.37, -1.05 ]
Wang 2008 100 4.38 (2.32) 100 5.22 (2.53) 39.4 % -0.34 [ -0.62, -0.07 ]
Total (95% CI) 124 126 100.0 % -0.59 [ -1.62, 0.44 ]
-4 -2 0 2 4
Analysis 5.2. Comparison 5 CBT-combined, Outcome 2 Self-reported distress.
Std.
Mean
Difference Weight
Std.
Mean
Difference
Bisignano 2006 14 1.64 (0.842) 16 2.25 (1.57) 32.9 % -0.46 [ -1.19, 0.27 ]
Liossi 1999 10 3.5 (1.08) 10 4.6 (0.52) 23.1 % -1.24 [ -2.22, -0.27 ]
Tyc 1997 28 2.7 (2.4) 27 3.1 (3) 44.0 % -0.15 [ -0.67, 0.38 ]
Total (95% CI) 52 53 100.0 % -0.50 [ -1.08, 0.07 ]
-4 -2 0 2 4
Analysis 5.3. Comparison 5 CBT-combined, Outcome 3 Observer-reported distress.
Std.
Mean
Difference Weight
Std.
Mean
Difference
Bisignano 2006 13 2.21 (1.12) 16 1.69 (0.75) 45.9 % 0.54 [ -0.21, 1.29 ]
Tyc 1997 28 2.15 (2.06) 27 3.1 (2.72) 54.1 % -0.39 [ -0.92, 0.14 ]
Total (95% CI) 41 43 100.0 % 0.04 [ -0.87, 0.95 ]
-4 -2 0 2 4
Analysis 5.4. Comparison 5 CBT-combined, Outcome 4 Behavioral measures- Distress
.
Std.
Mean
Difference Weight
Std.
Mean
Difference
Bisignano 2006 13 0.54 (0.877) 16 0.25 (0.577) 23.8 % 0.39 [ -0.35, 1.13 ]
Blount 1992 30 16.2 (16.1) 30 38.95 (26.37) 28.3 % -1.03 [ -1.57, -0.49 ]
Liossi 1999 10 8.9 (2.64) 10 12.6 (3.83) 19.5 % -1.08 [ -2.03, -0.12 ]
Tyc 1997 28 1 (1.1) 27 1.9 (2.6) 28.4 % -0.45 [ -0.98, 0.09 ]
Total (95% CI) 81 83 100.0 % -0.54 [ -1.16, 0.09 ]
-4 -2 0 2 4
Analysis 6.1. Comparison 6 Parent coaching + child distraction, Outcome 1 Self-r
eported pain.
Comparison: 6 Parent coaching + child distraction
Std.
Mean
Difference Weight
Std.
Mean
Difference
Kleiber 2001 22 3.24 (1.95) 22 2.7 (1.4) 14.9 % 0.31 [ -0.28, 0.91 ]
McCarthy 2010 240 3.39 (3.54) 278 3.07 (3.21) 68.7 % 0.09 [ -0.08, 0.27 ]
Windich-Biermeier 2007 22 0.28 (0.41) 28 0.84 (2.21) 16.4 % -0.33 [ -0.89, 0.23
]
Total (95% CI) 284 328 100.0 % 0.06 [ -0.19, 0.31 ]
-100 -50 0 50 100
Analysis 6.2. Comparison 6 Parent coaching + child distraction, Outcome 2 Observ
er-reported distress.
Std.
Mean
Difference Weight
Std.
Mean
Difference
Kleiber 2001 22 10.8 (4.2) 22 9.9 (4) 7.6 % 0.22 [ -0.38, 0.81 ]
McCarthy 2010 247 3.64 (2.15) 290 3.78 (2.16) 92.4 % -0.06 [ -0.23, 0.10 ]
Total (95% CI) 269 312 100.0 % -0.04 [ -0.21, 0.12 ]
-100 -50 0 50 100
Analysis 6.3. Comparison 6 Parent coaching + child distraction, Outcome 3 Behavi
oral measures- Distress.
Std.
Mean
Difference Weight
Std.
Mean
Difference
Blount 1992 30 16.2 (16.1) 30 38.95 (26.37) 30.9 % -1.03 [ -1.57, -0.49 ]
Kleiber 2001 22 1.89 (1.22) 22 2.13 (2.77) 29.5 % -0.11 [ -0.70, 0.48 ]
McCarthy 2010 244 3.18 (3.91) 287 3.27 (3.98) 39.6 % -0.02 [ -0.19, 0.15 ]
Total (95% CI) 296 339 100.0 % -0.36 [ -0.97, 0.25 ]
-4 -2 0 2 4
Analysis 7.1. Comparison 7 Suggestion, Outcome 1 Self-reported pain.
Comparison: 7 Suggestion
Std.
Mean
Difference Weight
Std.
Mean
Difference
Eland 1981 10 2.3 (0.82) 10 2.8 (0.63) 9.2 % -0.65 [ -1.56, 0.25 ]
Fowler-Kerry 1987 40 1.59 (1.13) 80 1.78 (1.14) 52.4 % -0.17 [ -0.55, 0.21 ]
Goodenough 1997 39 1.2 (2) 39 1.1 (1.6) 38.4 % 0.05 [ -0.39, 0.50 ]
Total (95% CI) 89 129 100.0 % -0.13 [ -0.40, 0.15 ]
-4 -2 0 2 4
A D D I T I O N A L T A B L E S
Table 1. Definitions of medical procedures
Procedure Definition
Immunization (also known as immunisation) Protection against a particular diseas
e or treatment of an organism by protecting
against certain pathogen attacks; the introduction of microorganisms that
have previously been treated to make them harmless
Venepuncture (also known as venipuncture) The surgical puncture of a vein typica
lly for withdrawing blood or administering
intravenous medication
Finger prick/pin Obtaining blood by puncturing the tip of the finger.
Injection The act of forcing a liquid into tissue, the vascular tree, or an orga
n
Subcutaneous injection Injection administered under the skin.
Intramuscular injection Injection administered by entering a muscle.
Lumbar punctures (LP) (also known as spinal tap) The withdrawal of cerebrospinal
fluid or the injection of anesthesia by puncturing
the subarachnoid space located in the lumbar region of the spinal cord
Table 1. Definitions of medical procedures (Continued)
Bone marrow aspiration (BMA) The bone marrow is the tissue that manufactures the
blood cells and is in the
hollow part of most bones. This test is done by suctioning some of the bone
marrow for examination
Bone marrow biopsy (BMB) The removal and examination of tissue, cells, or fluids
from the bone marrow
of a living body; usually performed at the same time as a BMA
IV/catheter insertion A narrow short, flexible, synthetic (usually plastic) tube
known as a catheter,
that is inserted approximately one inch into a vein to provide temporary intrave
nous
access for the administration of fluid, medication, or nutrients
Central line (also known as central venous catheter) Insertion of a catheter int
o the large vein above the heart, usually the subclavian
vein, through which access to the blood stream can bemade. This allows drugs
and blood products to be given and blood samples withdrawn
Suture (also known as laceration repair) A stitch made with a strand or fiber us
ed to sew parts of the living body
Accessing a portacath (also known as a port) Insertion of a needle into an impla
nted access device (portacath) which facilitates
the drawing of blood and intravenous (or intra-arterial) injections by
not having to locate and insert a cannula into a new vessel. Some ports are
connected for intrathecal, intraperitoneal or intracavitary injections
Arterial puncture A hole, wound, or perforation of an artery made by puncturing
Arterial blood gas (ABG) A test which analyses arterial blood for oxygen, carbon
dioxide and bicarbonate
content in addition to blood pH. Used to test the effectiveness of respiration
Arterial line (also known as intra-arterial catheter) Insertion of a catheter in
to an artery.
Thoracocentesis (also called thoracentesis) Aspiration of fluid from the chest.
Paracentesis A surgical puncture of a bodily cavity (e.g. abdomen) with a trocar
, aspirator,
or other instrument usually to draw off an abnormal effusion for diagnostic
or therapeutic purposes
Table 2. Means and standard deviations for outcomes from single trials
Intervention Outcome Study Treatment Control
N Mean (SD) N Mean (SD
Distraction Physiological
measure -
Respiratory rate
Nguyen 2010 20 25.1 (3.6) 20 28.5 (3.86)
Table 2. Means and standard deviations for outcomes from single trials (Continue
d)
Physiological
measure -
Systolic BP
Nguyen 2010 20 97.1 (8.57) 20 105.6 (15.97)
Physiological
measure -
Diastolic BP
Nguyen 2010 20 65.2 (6.83) 20 69.8 (11.67)
Hypnosis Observerreported
distress
Katz 1987 17 3 (0.9) 19 3.3 (0.6)
Behavioural
measure - Pain
Huet 2011 14 1.07 (1.05) 15 2.86 (2.16)
Preparation/
Information
Observerreported
pain
Harrison 1991 50 1.89 (1.27) 50 2.81 (1.11)
Observerreported
distress
Harrison 1991 50 2.43 (1.62) 50 3.17 (1.3)
Behavioural
measure - Distress
Tak 2006 26 2.64 (1.1) 28 2.37 (1.12)
Physiological
measure -
Pulse rate
Harrison 1991 50 84.6 (8.6) 50 88.6 (8.3)
Memory Alteration
Self-reported
pain
(during
procedure
change score)
Chen 1999 15 -0.06 (3.9) 9 -0.02 (3.2)
Observerreported
pain
(during
procedure
change score)
Chen 1999 20 04. (3.1) 22 -0.1 (1.8)
Observerreported
distress
(during
procedure
change score)
Chen 1999 25 -0.2 (2.6) 25 -0.5 (1.9)
Behavioural
measure - Distress
Chen 1999 25 -0.62 (3.7) 25 -0.48 (2.0)
d)
(during
procedure
change score)
Physiological
measure -
Heart rate
(during
procedure
change score)
Chen 1999 24 0.1 (26.9) 20 -4.9 (21.8)
Physiological
measure -
Cortisol
(during
procedure
change score)
Chen 1999 22 0.01 (0.18) 22 0.01 (0.2)
Physiological
measure -
Systolic BP
(during
procedure
change score)
Chen 1999 23 -0.5 (11.8) 19 -5.4 (7.9)
Physiological
measure -
Diastolic BP
(during
procedure
change score)
Chen 1999 23 -4.1 (10.9) 19 2.9 (10.2)
Parent Coaching
plus Child
Distraction
Self-reported
distress
Windich-
Biermeier 2007
22 0.36 (0.9) 28 0.54 (1.04)
Physiological
measure - Cortisol
responsivity
McCarthy 2010 115 23.4 (7.9) 123 50.8 (9.4)
Parent Position
plus Child Distraction
Self-reported
pain
Cavender 2004 20 2.3 (1.87) 23 2.74 (1.63)
Self-reported
distress
Cavender 2004 20 2.15 (1.81) 23 2.74 (1.86)
Observerreported
distress
Cavender 2004 20 1.24 (1.3) 23 2.34 (1.72)
d)
Behavioural
measure - Distress
Cavender 2004 20 13.7 (7.83) 23 16.39 (8.81)
Suggestion Self-reported
distress
Goodenough
1997
39 0.7 (1.1) 39 1.1 (1.3)
Observerreported
pain
Goodenough
1997
39 0.9 (1.6) 39 1.7 (2.3)
Observerreported
distress
Eland 1981 10 1.8 (0.71) 10 1.8 (0.79)
Blowing Out
Air
Self-reported
pain
Gupta 2006 25 1.24 (1.3) 25 4 (1.32)
Distraction
plus Suggestion
Self-reported
pain
Fowler-Kerry
1987
40 1.07 (1.02) 80 1.78 (1.14)
A P P E N D I C E S
Appendix 1. MEDLINE search strategy
1 Needles/
2 (needle* or inject*).mp.
3 (immuni* or vaccin* or finger prick* or heel prick*).mp.
4 (lumbar puncture* or spinal tap*).mp.
5 (bone marrow adj (aspiration or biops*)).mp.
6 (intravenous or intra-venous or venepuncture* or venous cannulation*).mp.
7 (catheter adj5 insert*).mp.
8 (central line adj5 insert*).mp.
9 (local adj (analges* or anaesthe* or anesthe*)).mp.
10 (arterial adj (puncture or line*)).mp.
11 (artery adj5 puncture).mp.
12 (thoracocentesis or paracentesis).mp.
13 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12
14 Pain/
15 ((needle* or immuni* or vaccin* or inject* or procedure* or intervention*) ad
j5 (pain* or distress* or discomfort or fear* or fright*
or anxious or anxiet*)).mp.
16 14 or 15
17 (rehears* or coping or verbal* encourage* or positiv* reinforce* or reward* o
r token* or self talk or selftalk* or stop signal* or
structured attention).mp.
18 ((cognitive* or behaviour* or behavior*) adj5 (intervention* or therap* or di
stract*)).mp.
19 (((audiovisual or audio visual or visual*) and distract*) or movie* or televi
sion* or tv or game* or toy* or virtual reality or tactile*
stimulat*).mp.
20 ((multisensory or multi-sensory) adj stimulation).mp.
21 Therapeutic Touch/
22 Relaxation/
23 Breathing Exercises/
24 Laughter Therapy/
25 exp Psychotherapy/
26 (desensiti* or relax* or therapeutic touch* or breathing exercise* or hypnosi
s or hypnoti* or hypnotherapy or image* or psychotherap*).
mp.
27 (autogenic training or auto suggestion*).mp.
28 ((colour* or color* or music* or play) and (therap* or distract*)).mp.
30 exp Child/
31 exp Infant/
32 exp Adolescent/
33 (child* or infant* or adolescent* or adolescence).mp.
34 30 or 31 or 32 or 33
35 13 and 16 and 29 and 34
key:
mp=title, original title, abstract, name of substance word, subject heading word
, unique identifier
Appendix 2. PsycINFO search strategy
4 (bone marrow adj (aspiration or biops*)).mp.
12 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11
13 Pain/
15 13 or 14
r token* or self talk* or selftalk* or stop signal* or
stract*)).mp.
sion* or tv or game* or toy* or virtual reality or tactile
stimulat*).mp.
20 exp relaxation therapy/
21 Relaxation/
22 exp psychotherapy/
mp.
26 16 or 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25
28 12 and 15 and 26 and 27
key:
[mp=title, abstract, heading word, table of contents, key concepts]
Appendix 3. CENTRAL search strategy
#1 MeSH descriptor Needles, this term only
#2 needle* or inject*
#3 immuni* or vaccin* or (finger next prick*) or (heel next prick*)
#4 (lumbar next puncture*) or (spinal next tap*)
#5 bone next marrow next (aspiration or biops*)
#6 intravenous or intra-venous or venepuncture* or (venous next cannulation*)
#7 catheter near insert*
#8 (central next line) near insert*
#9 local next (analges* or anaesthe* or anesthe*)
#10 arterial next (puncture or line*)
#11 artery near puncture
#12 thoracocentesis or paracentesis
#13 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12)
#14 MeSH descriptor Pain, this term only
#15 (needle* or immuni* or vaccin* or inject* or procedure* or intervention*) ne
ar (pain* or distress* or discomfort or fear* or fright*
or anxious or anxiet*)
#16 (#14 OR #15)
#17 rehears* or coping or (verbal* next encourage*) or (positiv* next reinforce*
) or reward* or token* or (self next talk*) or selftalk*
or (stop next signal*) or (structured next attention)
#18 (cognitive* or behaviour* or behavior*) near (intervention* or therap* or di
stract*)
#19 (((audiovisual or (audio next visual) or visual*) and distract*) or movie* o
r television* or tv or game* or toy* or (virtual next reality)
or (tactile next stimulat*))
#20 (multisensory or multi-sensory) next stimulation
#21 MeSH descriptor Therapeutic Touch, this term only
#22 MeSH descriptor Relaxation, this term only
#23 MeSH descriptor Breathing Exercises, this term only
#24 MeSH descriptor Laughter Therapy, this term only
#25 MeSH descriptor Psychotherapy explode all trees
#26 desensiti* or relax* or (therapeutic next touch*) or (breathing next exercis
e*) or hypnosis or hypnoti* or hypnotherapy or image*
or psychotherap*
#27 (autogenic next training) or (auto next suggestion*)
#28 (colour* or color* or music* or play) and (therap* or distract*)
#29 (#17 OR #18 OR #19 OR #20 OR #21 OR #22 OR #23 OR #24 OR #25 OR #26 OR #27 O
R #28)
#30 MeSH descriptor Child explode all trees
#31 MeSH descriptor Infant explode all trees
#32 MeSH descriptor Adolescent explode all trees
#33 child* or infant* or adolescent* or adolescence
#34 (#30 OR #31 OR #32 OR #33)
#35 (#13 AND #16 AND #29 AND #34)
Appendix 4. EMBASE search strategy
1 exp needle/
5 (bone adj (aspiration or biops*)).mp.
14 pain/
16 14 or 15
r token* or self talk* or selftalk* or stop signal* or
stract*)).mp.
sion* or tv or game* or toy* or virtual reality or tactile
stimulat*).mp.
21 breathing exercise/
22 HYPNOSIS/
23 exp psychotherapy/
mp.
27 17 or 18 or 19 or 20 or 21 or 22 or 23 or 24 or 25 or 26
28 child/
29 infant/
30 adolescent/
32 28 or 29 or 30 or 31
33 13 and 16 and 27 and 32
key:
mp=title, abstract, subject headings, heading word, drug trade name, original ti
tle, device manufacturer, drug manufacturer
Appendix 5. IBIWeb of Knowledge search strategy
# 6 396 #5 AND #4 AND #3 AND #2
Databases=SCI-EXPANDED,
SSCI,A&HCI,CPCI-S,
CPCI-SSH Timespan=2005-2011
(Continued)
# 5 >100,000 Topic=(audio visual* OR audiovisual*
OR touch*OR humorOR humour
OR laugh* OR psychotherapy
OR desensit*) OR Topic=(hypnotherap*
OR coach* OR inform*
OR thought-stop* OR thought
stop* OR thought*) OR Topic=
(coping* OR cope OR memor* OR
train*)
SSCI,A&HCI,CPCI-S,
# 4 >100,000 Topic=(intervention* OR cognitive*
OR cbt OR behavio* OR distract*
OR music*) OR Topic=(virtual reality
OR rehears* OR coping* OR
reinforce* OR hypnosis OR hypnot*)
OR Topic=(reward* OR selftalk
OR self talk OR relax* OR
breath* OR suggest* OR image*)
SSCI,A&HCI,CPCI-S,
# 3 >100,000 Topic=(intervention* OR cognitive*
OR cbt OR behavio* OR distract*
ORmusic*) OR Topic=(virtual reality
OR rehears* OR coping* OR reinforce*
OR hypnosis OR hypnot*)
SSCI,A&HCI,CPCI-S,
# 2 4,391 Topic=(child* OR youth* OR teen*
OR adolescen* OR infant*) AND
Topic=(pain* OR hurt* OR anxiety
OR anxious OR distress OR discomfort*
OR fear*) AND Topic=
(needle* OR inject* OR procedure*
OR vaccin* OR lumbar puncture*
OR bone marrow OR spinal tap
OR intravenous OR venepuncture*
(Continued)
OR venipuncture* OR catheter*
OR puncture* OR thoracentes* OR
paracentes* OR central line*)
SSCI,A&HCI,CPCI-S,
# 1 >100,000 Topic=(child* OR youth* OR teen*
OR adolescen* OR infant*)
SSCI,A&HCI,CPCI-S,
Appendix 6. CINAHL search strategy
Query
Limiters/Expanders
Last Run Via
Results
Action
S9
(AB ( intervention* OR cognitive* OR CBT OR behavio* OR distract* OR music* OR T
V* OR DVD* OR virtual reality OR
rehears* OR coping OR reinforcement* OR reward* OR self-talk OR self talk OR aud
iovisual OR audio visual OR movie* OR
therapeutic touch OR relax* OR breath* OR humor OR humour OR laughter* OR psycho
therapy OR desensit* OR hypnosis OR
hypnoti* OR hypnotherap* OR image* OR prepar* OR suggest* OR coach* OR inform* O
R thought-stop* OR though stop* OR
coping OR cope OR memor* OR train* or muscle* OR model* or rehears* )) and (S3 a
nd S4 and S5 and S6)
Expanders - Apply related words
Search modes - Boolean/Phrase
Interface - EBSCOhost
Search Screen - Advanced Search
Database - CINAHL with Full Text
272
Edit S9
S8
(AB ( intervention* OR cognitive* OR CBT OR behavio* OR distract* OR music* OR T
V* OR DVD* OR virtual reality OR
rehears* OR coping OR reinforcement* OR reward* OR self-talk OR self talk OR aud
iovisual OR audio visual OR movie* OR
therapeutic touch OR relax* OR breath* OR humor OR humour OR laughter* OR psycho
therapy OR desensit* OR hypnosis OR
hypnoti* OR hypnotherap* OR image* OR prepar* OR suggest* OR coach* OR inform* O
R thought-stop* OR though stop* OR
coping OR cope OR memor* OR train* or muscle* OR model* or rehears* )) and (S3 a
nd S4 and S5 and S6)
Display
Edit S8
S7
AB intervention* OR cognitive* OR CBT OR behavio* OR distract* ORmusic* OR TV*OR
DVD* OR virtual realityOR rehears*
OR coping OR reinforcement* OR reward* OR self-talk OR self talk OR audiovisual
OR audio visual OR movie* OR therapeutic
touch OR relax* OR breath* OR humor OR humour OR laughter* OR psychotherapy OR d
esensit* OR hypnosis OR hypnoti*
OR hypnotherap* OR image* OR prepar* OR suggest* OR coach* OR inform* OR thought
-stop* OR though stop* OR coping
OR cope OR memor* OR train* or muscle* OR model* or rehears*
Limiters - Published Date from: 20050101-
Display
Edit S7
S6
AB intervention* OR cognitive* OR CBT OR behavio* OR distract* ORmusic* OR TV*OR
DVD* OR virtual realityOR rehears*
OR coping OR reinforcement* OR reward* OR self-talk OR self talk OR audiovisual
OR audio visual OR movie* OR therapeutic
touch OR relax* OR breath* OR humor OR humour OR laughter* OR psychotherapy OR d
esensit* OR hypnosis OR hypnoti*
OR hypnotherap* OR image* OR prepar* OR suggest* OR coach* OR inform* OR thought
-stop* OR though stop* OR coping
OR cope OR memor* OR train* or muscle* OR model* or rehears*
Display
Edit S6
S5
AB pain* OR hurt* OR anxiety OR anxious OR distress* OR discomfort* OR fear*
Display
Edit S5
S4
AB child* OR youth* or teen* or adolescen* OR infant*
Display
Edit S4
S3
AB needle* OR inject* OR vaccin* OR lumbar puncture* OR bone marrow OR spinal ta
p OR intravenous OR venepuncture* OR
venipuncture* OR catheter* OR puncture* OR thoracentes* OR paracentes* OR centra
l line*
Display
Edit S3
S2
AB needle and AB pain and AB children
Display
Edit S2
S1
needle and pain and children
Display
Edit S1
WH A T ' S N EW
Last assessed as up-to-date: 2 September 2013.
Date Event Description
2 September 2013 New citation required and conclusions have changed Since the la
st version of this review (published in 2006)
, new relevant studies have provided additional information
to change the conclusions
20 March 2013 New search has been performed Review updated. This update differed
fromthe original
review by limiting the included studies to true RCTs
published in academic journals (i.e. excluded quasi-randomized
trials and dissertation studies). As such we excluded
seven studies from the 28 included in the original
review and added an additional 18 studies from this
review update, for a total of 39 RCTs included in the
update
H I S T O R Y
Protocol first published: Issue 1, 2005
Review first published: Issue 4, 2006
Date Event Description
24 September 2010 Amended Contact details updated.
13 May 2009 Amended Contact details updated.
2 July 2008 Amended Converted to new review format.
C O N T R I B U T I O N S O F A U T H O R S
Lindsay Uman was the lead review author and was involved with review development
, study searching, study retrieval, abstract and
study review, study selection, data extraction, data entry, statistical analyses
, and report writing.
Kathryn Birnie was involved in conducting literature searches, abstract and stud
y review, data extraction, risk of bias coding, report
writing, and report editing.
Melanie Noel was involved in conducting literature searches, abstract and study
review, data extraction, risk of bias coding, report
writing, and report editing.
Jennifer Parker was involved in conducting literature searches, reporting writin
g, and report editing.
Christine Chambers provided pediatric and pain management expertise, assisted wi
th protocol development, study selection, interpretation
of results, and report editing.
Patrick McGrath provided pediatric and pain management expertise, assisted with
protocol development, study selection, and report
editing.
Stephen Kisely provided expertise in conducting systematic reviews, statistical
analyses, protocol development, reporting results, and
report editing.
D E C L A R A T I O N S O F I N T E R E S T
None to declare
S O U R C E S O F S U P P O R T
Internal sources
No sources of support supplied
External sources
CGS-M Award from the National Science and Engineering Research Council (NSERC) a
warded to LS Uman (2004 to 2005),
Canada.
Graduate Award from the Nova Scotia Health Research Foundation (NSHRF) awarded t
o LS Uman (2005 to 2006), Canada.
Pain in Child Health (PICH) top-up funding awarded to LS Uman (2004 to 2006), Ca
nada.
Dalhousie Cochrane Group funding awarded to LS Uman, Canada.
Canada Research Chairs (CRCs) awarded to C Chambers and P McGrath, Canada.
D I F F E R E N C E S B E TWE E N P R O T O C O L A N D R E V I EW
Expanded age range from three to 18 to two to 18 years from the protocol to the
original review. This updated review differed from
the original review by excluding non-randomized trials and excluding non-publish
ed trials (for example, dissertations).
N O T E S
Not applicable.
I N D E X T E R M S
Medical Subject Headings (MeSH)
Needles; Anxiety [prevention & control; psychology]; Central Venous Catheters [adv
erse effects]; Cognitive Therapy [methods];
Hypnosis; Immunization; Pain [prevention &control; psychology]; Phlebotomy [psych
ology]; Punctures [psychology]; Randomized
Controlled Trials as Topic
MeSH check words
Adolescent; Adult; Child; Child, Preschool; Humans

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