SYNOPSIS

ST JOHN’S COLLEGE OF NURSING

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 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 NAME OF THE NAINA BABU

CANDIDATE

1ST YEAR MSc NURSING STUDENT

ADDRESS ST JOHN’S COLLEGE OF NURSING,
SARJAPURA ROAD,
BANGALORE-34

2 NAME OF THE ST. JOHN’S COLLEGE OF NURSING,

INSTITUTION BANGALORE

3 COURSE OF STUDY MASTERS DEGREE IN NURSING

SUBJECT CHILD HEALTH NURSING

4 DATE OF ADMISSION 02-05-2011

TO COURSE

5 TITLE OF THE TOPIC EFFECT OF DISTRACTION AND

EMLA CREAM ON PAIN
MANAGEMENT

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6. BRIEF RESUME OF INTENDED WORK

6.1 NEED FOR THE STUDY

Pain is an unpleasant sensory and emotional experience associated with actual

and potential damage. Children admitted to hospital often experience pain from
various treatments and test, as well as from illness itself. Understanding the ontogeny
of paediatric pain experience has increased over the past two decades1. Pain
associated with cancer, preoperative, postoperative period have all been extensively
studied and reviewed. But the general precept encompassing the pain associated with
venipuncture and intravenous cannulation and other routine procedure has been
viewed by the health care professionals as erroneous or having little significance and
impact. Increasing evidence has demonstrated that venous access procedures are an
important source of paediatric pain that should be managed proactively, as children
commonly undergo these procedures without the benefit of any analgesia.

Elimination or relief of pain and suffering, whenever possible is an important

responsibility of nurse caring for children, because unmanaged pain can result in a
variety of negative long term consequences2.Venipuncture and intravenous [IV]
cannula insertions are the two most common sources of pain in hospitalized children.
Intravenous cannulations were also found to be the second most common cause of the
worst pain experience during hospitalisation and also many observational and self
reports studies of children and adolescents undergoing routine venipuncture have
consistently demonstrated high levels of pain and distress in adolescents, pre
adolescents and toddlers1.

Despite the wealth of information highlighting the importance of pain

associated with venous access procedure, management strategies are often inadequate.
It has been recommended that, both pharmacological and cognitive behavioural
interventions such as distraction help to minimize the discomfort of painful
procedures. Distraction is considered to be a vehicle to modify how painful stimuli are
processed. When an individual is distracted, regional cerebral blood flow associated
with processing a painful event is reportedly reduced. Likewise when individual’s
attention is occupied by a distracting task, activation is reduced to the areas of the
brain associated with pain such as the thalamus, insula and the anterior cingulated

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cortex, producing correspondingly lower pain scores. A variety of distracters have
been used such as kaleidoscope, virtual reality glasses, party blowers, toys, music,
cartoon watching and non procedural talk. Overall distracters have been favourably
accepted by patients and parents and widely used in managing pain3.

Also pharmacological measures like application of local anaesthetic mixture

for venipuncture has been a field of research for paediatric pain management for
many years. A variety of options for local anaesthesia exists including Eutectic
Mixture of Local Anaesthetic cream, liposomal lidocaine cream, the lidocaine/
tetracaine patch and lidocaine iontophoresis. Studies have proved the efficacy of
EMLA in reducing children pain and distress during procedural pain and have been
recommended for daily usage in paediatric wards with minimal side effects4.

At St’ John’s Medical College Hospital (SJMCH) an average of 240-250

children, irrespective of age are admitted in paediatric wards per month and 90% of
them require venipuncture for reasons such as blood sampling, starting an IV line
either for infusion or for injections.

The investigators personal experience in doing venipuncture for children, lead

to the interest in developing a better method for managing pain in children. Studies on
pharmacological as well as behavioural methods have been done on this field
separately, but a comparison to identify the better method needs to be investigated
upon. Hence the following research topic has been selected among the two most
common method of pain management among children.

6.2 REVIEW OF LITERATURE

Review of literature is one of the vital parts of any research endeavour.

Review of literature is a brief summary of previous research findings of recognized
experts which provides evidences that researcher is familiar with what is already
known and what is still unknown and is to be tested. The researcher organized content
under the following headings.

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SECTION 1: LITERATURE RELATED TO DISTRACTION AND PAIN

MANAGEMENT.

Preparation of the child for a painful procedure is an intervention that requires

a great deal of attention from the medical professionals. The coping skills such as
relaxation, distraction or imagery can be used by the child to reduce both qualitative
and quantitative aspect of pain experience.

A study was done to investigate the effectiveness of a distraction technique in

reducing child’s perceived pain and behaviour distress during acute pain experience
among 100 children aged between 3 years 6 months and 12 year 11 months, who were
randomly assigned to the experimental and control group. Control subjects received
standard preparation while experimental subjects were encouraged to look through the
illusion kaleidoscope during the blood draw. FACES [Wong Baker faces pain rating
scale] and CHEOPS [The children’s hospital Eastern Ontario pain scale] scale were
used for measurement of pain and distress respectively. Findings revealed that
experimental group perceived less pain and demonstrated less behavioural distress
than the control group and the scores were positively correlated3.

A study was done to assess the effect of distraction on pain, fear, distress,
during venous port access and venipuncture in children with cancer. 50 children [5 to
18 years] were selected and randomly assigned to the control [standard therapy] or an
intervention group [standard therapy and distraction]. The children had to select the
distracter of their choice from -super challenger book, bubbles, music table, virtual
Reality glasses and game boy. The instruments used were Colour Analogue Scale
[pain and intensity], glasses fear scale [fear], and the Observation Scale for
Behavioural Distress [distress]. Results were that self reported pain and fear were
significantly correlated [p=.01] within treatment groups and intervention participants
demonstrated significantly less fear and distress5.

A Meta analysis was conducted in 1999, to determine the effects of distraction

on children’s pain and distress during medical procedures. Studies were searched
from Cancerlit, Healthstar, Medline and CINHAL. Nineteen studies were selected
which met all the inclusion criteria. The Hunter Schmidts procedure was used to
analyse the studies. The results indicated that the average effect size for the 535

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children who reported perceived pain was 0.62 indicating the positive effects of
distraction on pain levels in children. The analysis for behavioural distress among 491
children in the sample studies indicated that distraction has positive effect on
children’s distress behaviour. The researchers also recommended distraction as a low
cost intervention with no risk to the patient6.

A study examined nurse-directed distraction for reducing infant immunization

distress in America. Ninety infants and their parents were randomly assigned to a
distraction condition (i.e., nurses used stimuli to divert infant’s attention) or a typical
care condition. Outcome measures were an observational scale, parent and nurse
ratings, and infant heart rate. Results indicated that infants engaged in distraction had
lesser behavioural distress. However, ratings and heart rate were inconclusive7.

SECTION 2: LITERATURE RELATED TO EMLA CREAM AND PAIN

MANAGEMENT

A study conducted in Finland to assess the effect of the topical application of a

lignocaine-prilocaine cream (EMLA) on the pain of venous cannulation, with a
double-blind experimental design. Sixty boys and girls between the ages of 4 and 10
years who were to undergo surgery participated in the study. No analgesic
premedication was given and the venous cannulation was performed during the
preparation for general anaesthesia. Pain was assessed by the anaesthetist and the
patient using a verbal rating scale and two different pictorial scales. The effect of
EMLA in the alleviation of the pain of venous cannulation was considered
significantly better than placebo by both anaesthetist (P<0.001) and patient (P<0.05)
(verbal scales). Local reactions to the cream were minor and transient in both groups8.

A randomised double blind controlled trail done in 1999, to measure the

antibody response to measles-mumps-rubella (MMR) vaccine, as well as pain
reduction associated with the use of the EMLA patch. 160 healthy infants, 12 months
old undergoing MMR immunization were selected. The experimental group received
EMLA patch (5%-1 g) and control received placebo before MMR immunization.
Blood sampling before and 28 to 35 days after immunization was done. The outcome

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variables were pain scores by the Modified Behavioural Pain Scale and drug and
vaccine associated adverse events. There was no difference in the antibody response
between the EMLA- and placebo-treated groups (P > .05 for all comparisons). EMLA
recipients had less pain and less irritability after immunization (P = .043) than did
placebo recipients9.

Department of anaesthesiology, Arkansas children’s hospital USA conducted

a study, with a 2 x 2 randomized block design, to demonstrate that parent application
of eutectic mixture of local anaesthetics (EMLA) results in equal reduction of the pain
of intravenous (IV) placement compared with clinician application of EMLA.41
children divided into, two age groups (5-12 years vs. 13-18 years) were randomly
allocated to two experimental groups. EMLA was placed at least 60 minutes before
IV insertion. Outcome measures were child pain ratings and observed behavioural
distress rating. There were no significant differences in pain or distress ratings for
either the age or the experimental groups. In addition, the younger children reported
more anxiety when clinicians applied the EMLA and older children when parents
applied the EMLA10.

SECTION 3: LITERARURE RELATED TO COMPARISON OF

PHARMACOLOGICAL AND COGNITIVE BEHAVIOURAL METHODS
FOR PAIN MANAGEMENT

This study was undertaken by Department of Psychology, Washington State,

to compare the effect of distraction, an anaesthetic [EMLA], and typical care during
paediatric immunizations. Participants were 39, 4th graders receiving a 3-injection
vaccination series over a 6-month period. Distraction resulted in more nurse coaching
and child coping and less child distress than did EMLA or typical care on an
observational measure. Whereas participant ratings and heart rate did not differ
among conditions. Satisfaction ratings suggested that children preferred the treatments
to typical care. Finally, distraction was more economical than EMLA11.

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 Children aged 5-12yr requiring venipuncture were enrolled in a prospective
randomized clinical trial conducted at a tertiary care centre, Mumbai. They were
randomly assigned to 3 groups: local anaesthetic (LA), music and placebo (control)
group. Pain was assessed independently by parent, patient, investigator and an
independent observant at the time of insertion of the cannula (0 min) and at 1- and 5
min after the insertion using a Visual Analogue Scale (VAS). Significantly higher
VAS scores were noted in control (placebo) group by all the categories of observers
(parent, patient, investigator, independent observer) at all time points. The VAS
scores obtained in LA group were lowest at all time points. However the difference
between VAS scores with LA and music is not always significant. Hence, the choice
between EMLA and music could be dictated by logistical factors12.

A study was performed to compare the effect of distraction and eutectic

mixture of local anaesthetic (EMLA) cream on pain intensity of IV cannulation in 32
thalasemic children aged 5-12 years selected by convenient sampling method. The
study was conducted in three stages with 14 days intervals. Data was collected using
OUCHER scales and CMFS questionnaire. There was a significant difference
between mean pain intensity (numeral and photographic) of distraction and EMLA
cream methods compared to the control, but not between distraction and EMLA
cream methods. Findings showed that both distraction and EMLA cream procedures
decreased pain of IV catheter with the same level of efficacy13.

6.3 PROBLEM STATEMENT

A study to compare the effects of distraction and EMLA cream on pain level during
venipuncture among children admitted in a tertiary care hospital, Bangalore.

6.4 OBJECTIVES OF THE STUDY

1. To determine the effects of distraction on pain level during venipuncture.

2. To determine the effects of EMLA cream on pain level during venipuncture.
3. To compare the pain levels of children in both groups undergoing
venipuncture.
4. To determine the association of pain level with selected baseline variables.

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6.5 OPERATIONAL DEFINITIONS

EFFECT

A change which is a result or consequence of an action

Oxford English dictionary

In this study it is the ability of distraction or EMLA cream in reducing the

pain, as evidenced by the scores obtained by the WONG BAKER’S faces pain rating
scale.

DISTRACTION

To draw the attention away from something

Oxford English dictionary

In this study it refers to, diverting the child’s attention from painful
venipuncture with the help of kaleidoscope, which is a visual toy in which series of
patterns of images are placed. Child can view it through a viewing apparatus.

VENIPUNCTURE

The technique in which vein is punctured by a sharp rigid needle or cannula

carrying a flexible plastic catheter for diagnostic and therapeutic purposes.

Mosby’s Medical dictionary

In this study it includes venipuncture for insertion of IntraVenous cannula for

medication administration, IV infusion and blood transfusion.

EMLA CREAM

It refers to the Eutectic mixture of local anaesthetic cream which includes

Lidocaine 25 mg and Prilocaine 25 mg. The cream will be directly applied over the
skin [2 sq cm area] by using the spatula available in the cream packet, 20-45 minutes

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prior to the venipuncture and the required quantity is 0.2 gm. The cream will be
removed and site will be prepared for procedure as usual.

PAIN

Pain is defined as an unpleasant sensory and emotional experience associated

with actual or potential tissue damage.

Mersey and Bogduk 1994

In this study it refers to the subjective experience of discomfort which is

measured and scored using WONG BAKER’S faces pain rating scale after the
venipuncture procedure.

CHILDREN

In this study it refers to those children between ages 4 years to 12 years

admitted in the paediatric wards of St John’s Medical College Hospital [SJMCH],
Bangalore during the study period.

SELECTED BASE LINE VARIABLES

Refers to child’s age, gender, previous experience of venipuncture, primary

care givers presence during the procedure, size of the needle and duration of EMLA
cream application.

6.6 ASSUMPTIONS

1. Every child is unique and responds in a unique way to painful medical

procedure.
2. One of the many non pharmacological methods to manage pain is distraction.
3. One of the safest pharmacological interventions for pain management is
EMLA cream application.

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6.7 DELIMITATIONS

The study is delimited to

1. Venipuncture for insertion of IV cannula for medication administration, IV

infusion and blood transfusion.
2. Children between 4 to 12 years
3. Paediatric ward of St John’s Medical College Hospital, Bangalore.

6.8 PROJECTED OUTCOME

Findings of the study will reveal the preferred method for pain management
during venipuncture in the paediatric wards, which will serve as an evidence to
initiate a common practice among staff nurses.

6.9 HYPOTHESES

H1- There will be a significant difference between the pain levels of children
receiving EMLA compared to children receiving distraction at 0.05 level of
significance.

H2- There will be a significant association between pain levels of children and
selected base line variables at 0.05 level of significance.

7. MATERIALS AND METHODS

7.1 SOURCES OF DATA

7.1.1 RESEARCH DESIGN

Quasi experimental design

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7.1.2 SETTING

The setting of the study will be the paediatric medical ward of St John’s
Medical College Hospital, Bangalore, which consists of 61 beds and is situated on the
first floor. Approximately 150-180 admissions are present in a month and 4-5
venipunctures for IV cannulations per day are conducted routinely for diagnostic and
therapeutic purpose.

7.1.3 POPULATION

Population in this study includes all children who are scheduled for
venipuncture in the paediatric wards of St John’s Medical College Hospital,
Bangalore.

7.2 METHOD OF DATA COLLECTION

7.2.1 SAMPLING PROCEDURE

The Sampling procedure used will be purposive sampling

7.2.2 SAMPLE SIZE

The sample size will be 80 children undergoing venipuncture.

Distraction group- 40, EMLA cream group- 40.

7.2.3 INCLUSION CRITERIA FOR SAMPLING

All children who are

 Scheduled for venipuncture
 Aged between 4 and 12 years
 Conscious and mentally alert

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7.2.4 EXCLUSION CRITERIA FOR SAMPLING

All children who are

 Critically ill
 Have neurological deficit/ developmentally delayed
 Punctured twice to get the access to vein.
 Known history of allergy to local anaesthesia.

7.2.5 INSTUMENTS USED

SECTION 1- Interview schedule to obtain demographic variables

SECTION 2- Standardized WONG BAKER’S faces pain rating scale, to measure

child’s subjective experience of pain.

7.2.6 DATA COLECTION METHOD

After obtaining administrative permission from the St John’s Medical College

Hospital. Children will be identified, as per the inclusion criteria by purposive
sampling method and will be randomly allocated to Distraction and EMLA group
using the Lot method with replacement. Two equally qualified and experienced staff
will be selected from the paediatric wards for doing the venipuncture for the study.

DISTRACTION GROUP- For the samples allocated to the distraction group, first
purpose of the study will be explained to the parents of the child. Parents and child
will be explained about the Kaleidoscope and to use it prior to the procedure and the
base line data will be collected. During the procedure child will be constantly
encouraged to focus their attention on the distracter. After the procedure, which is
after the application of the tape to secure the cannula, pain of the child will be
assessed using Wong Baker’s faces pain rating scale.

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EMLA GROUP- In the samples allocated to the EMLA group, before the procedure,
the purpose and need of the study will be explained to the parents, written consent
will be obtained and base line data will be collected. The selected children will be
informed that the cream will be applied to make the procedure easy without
mentioning anything about the reduction in pain. 20 to 45 minutes prior to the
procedure after marking the site for venipuncture on 2 sqcm area, 0.2gm of EMLA
cream will be applied using the spatula present in the container and occlusive dressing
will be placed. After 20 to 45 minutes cream will be removed and site will be
prepared for venipuncture. After the procedure, pain of the child will be assessed
using Wong Baker’s faces pain rating scale.

7.2.7 DATA ANALYSIS PLAN

Data will be analysed using descriptive statistics such as frequency,

percentage, mean and standard deviation. Inferential statistics such as t- test and chi
square

7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR

INTERVENTION TO BE CONDUCTED ON PATIENTS OR HUMANS OR
ANIMAL? IF SO PLEASE DESCRIBE BRIEFLY.

Yes. This study requires intervention to be conducted with EMLA cream

application on child’s skin before venipuncture.

7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR

INSTITUTION IN CASE OF 7.3?

Administrative permission and ethical clearance with regard to the study will
be obtained from the research committee of St John’s Medical College Hospital,
Bangalore prior to the study.

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insertion pain and distress in children. www.pediatric.org/cgi/doi/10.1542/peds2008-

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lidocaine delivery system provides rapid effective analgesia for venipuncture or

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EMLA) in children. British journal of anesthesia.1986; 58(11):1242-1245.

9) Halperin SA, McGrath P, Smith B, Houstan T. Lidocaine prilocaine patch decreases

the pain associated with subcutaneous administration of measles, mumps, rubella

vaccine but does not adversely affect the antibody response. Journal of

paediatrics.2000; 136(6):789-94

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application of eutectic mixture of local anaesthesia for IV insertion. Paediatrics.1999;

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distraction versus topical anaesthesia for paediatric pain management during

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impact of preparation of EMLA ointment on behavioural reactions during intravenous

cannulation of 6-12 years children with cancer. Pediatric Blood and Cancer.2007;

49(4): 414.

17) Hellgren U, Kihamia CM, Premji Z and Danielson K. Local anaesthetic cream in

alleviation of pain during venepuncture in Tanzanian school children. British Journal

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18) Fein JA, Callahan JM, Boardman CR and Gorelick M H. Predicting the need for

topical anaesthetic in the paediatric emergency department.1999; 104(2): 1-5.

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for IV insertion in children: randomized equivalent study.

http://pediatrics.aappublications.org/content/110/4/758.full.html

21) Cohen LL. Reducing infant immunization distress through distraction. Health

Psychology.2002; 21: 207-11.

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23) Halperin SA, Mc Grath P, Smith B, et al. Lidocaine Prilocaine patch decreases the

pain associated with the subcutaneous administration of measles- mumps- rubella

vaccine but does not adversely affect the antibody response. J Pediatrics.2000;136:

789-94

24) Cassidy KL, Reid GJ, Mc Grath PJ, et al. A randomized double blind ,placebo

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8 SIGNATURE OF THE CANDIDATE

9 REMARKS OF THE GUIDE

10 NAME AND DESIGNATION OF

10.1 GUIDE MRS. SHEEJA P P
ASSOCIATE PROFESSOR
CHILD HEALTH NURSING
ST JOHN’S COLLEGE OF
NURSING
BANGALORE

10.2 SIGNATURE

10.3 CO GUIDE DR. LALITHA A V

ASSOCIATE PROFESSOR
DEPT OF PEDIATRICS
ST JOHN’S MEDICAL COLLEGE
HOSPITAL
BANGALORE

10. 4 SIGNATURE

11 11.1 HEAD OF THE DEPARTMENT MRS. SHEEJA P P

ASSOCIATE PROFESSOR
CHILD HEALTH NURSING
ST JOHN’S COLLEGE OF
NURSING
BANGALORE
11.2 SIGNATURE

12
12.1 REMARKS OF THE
CHAIRMAN AND THE PRINCIPAL

12.2 SIGNATURE

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