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Article in Pain management nursing: official journal of the American Society of Pain Management Nurses · June 2014

DOI: 10.1016/j.pmn.2014.03.003 · Source: PubMed

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Original Article

Effectiveness of External Cold and Vibration for Procedural Pain Relief During Peripheral Intravenous Cannulation in Pediatric Patients

- ABSTRACT:

- - - Nejla Canbulat, PhD, * Fatma Ayhan,

MSc,

and Sevil Inal, PhD

From the *Nursing Department, Karamano glu Mehmet Bey University, Karaman, Turkey; Selcuk University, Institute of Health Science, Surgical Nursing, Konya, Turkey; Istanbul University, Health Science Faculty, Midwifery Department, Istanbul, Turkey.

Address correspondence to Nejla Canbulat, PhD, Department of Nursing, Karamano glu Mehmet Bey University, Karaman 70100, Turkey. E-mail: ncanbulat@gmail.com

Received October 6, 2012; Revised March 12, 2014; Accepted March 17, 2014.

The authors report there are no conflicts of interest.

1524-9042/$36.00

2015 by the American Society for Pain Management Nursing

The aim of this study was to investigate the effect of external cold and vibration stimulation via Buzzy on the pain and anxiety level of chil- dren during peripheral intravenous (IV) cannulation. This study was a prospective, randomized controlled trial. The sample consisted of 176 children ages 7 to 12 years who were randomly assigned to two groups: a control group that received no peripheral IV cannulation intervention and an experimental group that received external cold and vibration via Buzzy. The same nurse conducted the peripheral IV cannulation in all the children, and the same researcher applied the external cold and vibration to all the children. The external cold and the vibration were applied 1 minute before the peripheral IV cannu- lation procedure and continued until the end of the procedure. Pre- procedural anxiety was assessed using the Children’s Fear Scale, along with reports by the children, their parents, and an observer. Proce- dural anxiety was assessed with the Children’s Fear Scale and the parents’ and the observer’s reports. Procedural pain was assessed us- ing the Wong Baker Faces Scale and the visual analog scale self-reports of the children. Preprocedural anxiety did not differ significantly. Comparison of the two groups showed significantly lower pain and anxiety levels in the experimental group than in the control group during the peripheral IV cannulation. Buzzy can be considered to provide an effective combination of coldness and vibration. This method can be used during pediatric peripheral IV cannulation by pediatric nurses. 2015 by the American Society for Pain Management Nursing

INTRODUCTION

The simple insertion of a needle has been shown to be one of the most frightening and distressing medical procedures for hospitalized children (Baxter et al., 2011;

Pain Management Nursing, Vol 16, No 1 (February), 2015: pp 33-39

34

Canbulat, Ayhan, and Inal

Cohen 2008; Kolk, van Hoof, & Fiedeldij Dop, 2000). It is well known that even minor and frequently performed procedures, such as peripheral intravenous (IV) cannulation, invoke significant pain in children and increase fear and anxiety in children and their caregivers (Smith, Shah, Goldman, & Taddio, 2007). Thus, interest in the management and study of pain in children has increased in recent years. Nurses should be able to manage painful procedures to reduce their emotional and physical effects in children (Rogers & Ostrow, 2004). Various approaches to manage pain, including pharmacologic and nonpharmacologic methods, have been described (Taddio et al., 2010). Pharmacologic op- tions, such as 5% lidocaine-prilocaine cream, 4% tetra- caine gel, 4% lidocaine cream, needle-free powder lidocaine (S-Caine Patch) and iontophoresis, provide adequate cutaneous analgesia for a variety of clinical situ- ations. However, most of these formulations have limita- tions, and there have been reports of adverse reactions (Pershad, Steinberg, & Waters, 2008; Sethna et al., 2005; Zempsky et al., 2008). To date, no single formulation or physical means of improving the permeation of local anesthetics has gained universal acceptance because of the aforementioned limitations (cost and duration of this application) (Sethna et al., 2005). Additionally, most cur- rent options are time consuming, costly, and require staff

training (Fein & Gorelick, 2006; Leahy et al., 2008). This is

a problem for busy medical settings, such as emergency

departments or immunization departments (MacLean, Obispo, & Young, 2007). Nonpharmacologic techniques are generally divided into physical and behavioral tech- niques. Physical techniques include, but are not limited to, injections, massage, and counter-stimulation. Behav- ioral techniques include music distraction, cartoon distraction, communication, the valsalva maneuver, and blowing into sphygmomanometer tubing (Dutt-Gupta, Brown, & Mycama, 2007; Sinha, Tandon, & Singh, 2005). Despite anecdotal evidence of the efficacy of these techniques, there has been very limited evaluation of these interventions for procedural pain in children (MacLaren & Cohen, 2007). An easy-to-use, inexpensive, and rapid method is needed that can ameliorate proce- dural pain and anxiety in busy medical settings. External

cold and vibration via Buzzy (MMJ Labs, Atlanta, GA, USA)

is a method that combines cooling and vibration (www.

buzzy4shots.com) (Fig. 1). Buzzy was applied in an adult population during cannulation attempts and found to be effective for pain relief (Baxter, Leong, & Matthew, 2009). The Gate Control Theory may offer an explanation for the effect of cold stimulation and vibration (Melzack & Wall, 1965). This theory suggests that pain is transmitted from the peripheral nervous system to the central nervous sys- tem, where it is modulated by a gating system in the dor- sal horn of the spinal cord. The afferent pain-receptive

sal horn of the spinal cord. The afferent pain-receptive F IGURE 1. - Buzzy ( www.buzzy4shots.com

F IGURE 1. - Buzzy (www.buzzy4shots.com ).

nerves (A-d fibers carrying acute pain and unmyelinated slower C fibers carrying chronic pain messages) are blocked by fast non-noxious motion nerves (A-b) (Kakigi & Shinbasaki, 1992). Prolonged cold stimulates the C fibers and may block the A-d pain signals. Cold also may result in enhanced activation of supraspinal mechanisms, raising the body’s overall pain threshold (Nahra & Plaghki, 2005). Only two published studies have investigated the application of the Buzzy method in pediatric popula- tions during venipuncture (Baxter et al., 2011; Inal & Kelleci, 2012 ). There have been no published studies of the application of this method in pediatric populations during peripheral IV cannulation. The aim of this study was to investigate the effects of external cold and vibration via Buzzy on pain and anxiety levels during peripheral IV cannulation in children aged 7 to 12 years.

Research Hypotheses Hypothesis 1: Buzzy reduces procedural pain felt dur- ing peripheral IV cannulation in pediatric patients. Hypothesis 2: Buzzy reduces procedural anxiety felt during peripheral IV cannulation in pediatric patients.

MATERIAL AND METHODS

The study was conducted in the Pediatric Surgical Department of the Maternal and Child Hospital in Kara- man, Turkey, between July and September 2012. This was a randomized clinical trial. Informed consent was obtained from each child’s parents. During the peripheral IV cannulation, the nurse used the dorsum of the child’s left or right hand,

Cold, Vibration as Pain Relievers

35

depending on whether the child was left- or right- handed. In left-handed children, the peripheral IV can- nulation was inserted in the dorsum of the right hand. In right-handed children, it was inserted in the dorsum

of the left hand. External cold and vibration stimulation were applied with Buzzy. Buzzy is a reusable 8 5 2.5-cm plastic bee containing a battery and vibrating motor. Buzzy was designed especially for pain control in children and adults. An ice pack is placed under the device. The combination of coldness and vibration with Buzzy is considered more effective than the use

of cold or vibration. In Turkey, routine nonpharmaco-

logic methods are not used to reduce the pain and anx- iety associated with peripheral IV cannulation.

Sample The inclusion criteria were patients aged 7 to 12 years who required peripheral IV cannulation. Potential par- ticipants were excluded if there was a break or abra- sion on the skin where the device would be placed. Additional exclusion criteria were nerve damage in the affected extremity, critical or chronic illness or poor health, neurodevelopmental delays, verbal diffi-

culties, use of an analgesic within the last 6 hours, or a history of syncope due to blood specimen collection

or immunization. None of the children had any prior experience of peripheral IV cannulation.

Ethical Considerations This study was approved by the Ethical Commission of Selcuk University Selcuklu Medical. Faculty, Konya (06. 26.2012/115). The aim and the method of the study were explained to the children and their parents, and they were informed that if they did not want to continue, they could withdraw from the study without stating a reason.

Procedure

This study was conducted with one volunteer nurse trained by the researcher. The nurse had 5 years of experience in pediatric patient care and peripheral

IV cannulation. The nurse had no monetary interest.

The nurse was informed about the study at the begin- ning. The preprocedural and procedural fear and

anxiety levels of the children were assessed via self- parental and observer reports. The data were obtained

by interviewing the children, their parents, and the

observer. The Children’s Fear Scale (CFS) was used

for this purpose. The CFS is a well-established method

for evaluating pediatric fear and anxiety. It rates fear and anxiety on a 5-point scale and consists of five cartoon faces that range from a neutral expression (0 ¼ no anxiety ) to a frightened face (4 ¼ severe anxiety ) ( McMurtry, Noel, Chambers, & McGrath 2011 ). The

responses of the children, their parents, and the ob- servers were scored blindly. The children’s pain levels immediately after the pe- ripheral IV cannulation procedure were also assessed via self-reports using the Wong Baker Faces Scale (WBFC) and the visual analog scale (VAS) (Hockenberry & Wilson, 2009; Wewers & Lowe, 1990 ). The WBFC is a scale ranging from 0 to 10, consisting of six cartoon faces that range from a neutral expression (0 ¼ very happy/no pain ) to a screaming face (10 ¼ hurts more than you can imagine ) (Hockenberry & Wilson, 2009 ). The VAS is a measurement instrument that tries to measure a char- acteristic or attitude that is believed to range across a continuum of values and cannot easily be measured directly. For example, the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. The VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end. The child marks on the line the point that he or she feels represents his or her perception of the current state. The VAS score is determined by measuring in millimeters from the left-hand end of the line to the point that the child marks (Wewers & Lowe 1990 ). The same nurse conducted the peripheral IV can- nulation procedure in all cases. The same researcher applied the external cold and vibration stimulation via Buzzy ( Fig. 2 ). The children (N ¼ 220) and their parents were informed about the purpose and the content of the study and asked if they would volunteer to participate in the study. Of the 220 children, 176 children and their parents agreed to participate. All the parents signed a research consent form. Background informa- tion about demographics, medical history, recent

informa- tion about demographics, medical history, recent F IGURE 2. - An example of the use

FIGURE 2. - An example of the use of Buzzy ( www. buzzy4shots.com ).

36

Canbulat, Ayhan, and Inal

analgesics, and body mass index (BMI) were collected via self-report forms. Before randomization, the researcher read a standard script to explain the pain and anxiety measures. The parents and the observer

(the researcher) assessed the children’s anxiety levels. The 176 children were randomized using a computer- generated table of random numbers into two equal groups: an experimental group and a control group (n ¼ 88 for each group). The control group received

no intervention. The experimental group received

external cold and vibration stimulation via Buzzy. The dorsum of the child’s hand area was cleaned and can- nulated with Buzzy. Buzzy was administered about 5

cm above the application area just before the proce-

dure, and the vibration was continued until the end of the procedure.

Data Analysis Data were analyzed with SPSS version 15.00 (SPSS, Inc., Chicago, IL, USA). A p value < .05 was considered

significant. Parametric data, such as the pain and anxi-

ety levels of the children, were compared with the Stu-

dent’s t test. Nonparametric data, such as sex and mother’s and father’s education, were compared with frequency and c 2 comparisons.

RESULTS

The study was conducted between July and September

2012. One hundred seventy-six children aged 7 to 12

years (8.43 1.61 years) and their parents volunteered to participate in the study. There were no differences between the two groups in terms of age, sex, BMI, and preprocedural anxiety according to the self, the parents’, and the observer’s reports (p > .05) ( Table 1 ). When pain and anxiety levels were compared with an independent sample t test, consistent with hy- pothesis 1, the children in the external cold and vibra- tion stimulation group had significantly lower pain levels than the control group according to their self- reports (both WBFC and VAS scores; p < .001) (Table 2 ). Consistent with hypothesis 2, the external cold and vibration stimulation group had significantly lower fear and anxiety levels than the control group, according to the parents’ and the observer’s reports (p < .001) (Table 3).

DISCUSSION

Pain experienced during medical procedures that are routinely performed in hospitals, such as phlebotomy, immunization, and IV cannulation, can cause stress, fear, and anxiety in children (Cassidy et al., 2001; Razzaq, 2006 ). These procedures also may cause anxiety and fear in the family members of these children ( Cohen, 2008; Shavit & Hershman, 2004 ). Although procedural pain and anxiety levels may be influenced by the type of procedure applied ( Rawe et al., 2009 ), they also are associated with a number of individual factors, including the child’s and parents’

T ABLE 1.

Comparison of Groups in Terms of Variables that May Affect Procedural Pain and Anxiety Levels

 

c 2

Characteristic

Buzzy (n ¼ 88)

Control (n ¼ 88)

p

Sex Female (%) n Male (%) n

11 (12.5)

13 (14.8)

.82

77 (87.5)

75 (85.2)

.41

 

t

Characteristic

Buzzy (n ¼ 88)

Control (n ¼ 88)

p

Age (mean SD)

8.25 1.51

8.61 1.69

–1.498

 

.136

BMI (mean SD)

25.41 6.74

26.94 8.68

–1.309

 

.192

Preprocedural anxiety Self-report (mean SD)

2.03 1.29

2.11 1.58

–0.364

 

.716

Parent report (mean SD)

2.11 1.20

2.17 1.42

–0.285

 

.776

Observer report (mean SD)

2.18 1.17

2.24 1.37

–0.295

.768

Cold, Vibration as Pain Relievers

37

T ABLE 2.

Comparison of Groups’ Procedural Pain Levels During Peripheral IV Cannulation

 

Buzzy

Control

t

(n

¼ 88)

(n

¼ 88)

p

Procedural self- reported pain with WBFS (mean SD) Procedural self- reported pain with VAS (mean SD)

2.75

2.68

5.70 3.31

–6.498

 

0.000

1.66

1.95

4.09 3.21

–6.065

 

0.000

IV ¼ intravenous; VAS ¼ visual analog scale; WBFS ¼ Wong Baker Faces

Scale.

emotional status, previous experiences, and physi- cians’ skills. The American Society for Pain Manage- ment Nursing recommends that optimal pain control before and during painful procedures be provided ( Czarnecki et al., 2011 ). Therefore, pharmacologic and nonpharmacologic approaches are recommended to control pain and the resulting future anxiety behavior (Schechter et al., 2007 ). The results of this study suggest that external cold and vibration stimulation via Buzzy are effective for reducing pain and anxiety in children during periph- eral IV cannulation. Studies reported that children who had frequently experienced needle-sticks re- ported less pain than children who had experienced few needle-sticks (Inal & Kelleci 2012; McCarty, & Kleiber, 2006 ). In this study, the children in both groups were similar in terms of the factors that might influence pain perception, such as age, sex, BMI, and levels of preprocedural anxiety. This supports the efficiency of the external cold and vibration stimulation method via Buzzy in reducing pain and anxiety levels of children. Previous research has shown the long-term negative effects of early

T ABLE 3.

Comparison of Groups’ Procedural Anxiety Levels During Peripheral IV Cannulation

Procedural child

Buzzy

Control

t

anxiety

(n

¼ 88)

(n

¼ 88)

p

Parent reported (mean SD) Observer reported (mean SD)

0.94

1.06

2.09 1.39

–6.135

 

0.000

0.92

1.03

2.14 1.34

–6.745

 

0.000

IV ¼ intravenous.

pain experiences in children ( Thurgate & Heppell, 2005 ). Another study demonstrated that reduction in- creases patient satisfaction during needle procedures (Magaret, Clark, Warden, Magnusson, & Hedges,

2002 ). Although a large number of pharmacologic

and nonpharmacologic methods have been used for pain relief during medical procedures in the past, and many methods are employed in the present, there is no single integrated intervention to optimize pain re- lief. A widely used pharmacologic method for pain re- lief is topical anesthetics (O’Brien, Taddio, Ipp, Goldbach, & Koren, 2004 ) during peripheral IV cannu- lation. In a pilot study conducted by Baxter et al. (2009) , external thermo-mechanical stimulation via cold application and vibration was applied to adults during cannula placement. The researchers compared pain reduction with external cold and vibration stimu- lation with that of the Vapocoolant spray. Compared with a control group, where no means of pain reduc- tion was used, both methods were found to be effec- tive. There was no statistically significant difference between the Vapocoolant spray and the external cold and vibration stimulation in terms of pain reduction. In another randomized controlled study conducted by Baxter et al. (2011) , external cold and vibration stimulation were found to be as effective as the Vapo- coolant spray (the standard procedure) for pain relief in children during IV access. Inal and Kelleci (2012) re- ported that the application of external cold and vibra- tion stimulation via Buzzy are effective in relieving pain and anxiety in children during blood specimen collec- tion. In our study, the pain and anxiety levels of the Buzzy group were lower than those of the control group. It is widely accepted that most children who previously experienced a painful medical procedure also perceive fear and anxiety in future procedures. Therefore, decreasing the emotional effects of painful procedures in clinical practice with better pain control is essential in children. To avoid future undesirable ef- fects of painful medical procedures, successful pain control should be the objective in all procedures.

CONCLUSION

The application of external cold and vibration stimula- tion were effective in relieving pain and anxiety in chil-

dren during peripheral IV cannulation. Therefore, it

can be concluded that this method may be routinely used during peripheral IV cannulation in children. Nurses need to be aware of procedural anxiety and pain during peripheral IV cannulation. Interventions should be implemented to decrease anxiety and pain in children. Nurses can use external cold and vibration stimulation for pain and anxiety relief in children

38

Canbulat, Ayhan, and Inal

during peripheral IV cannulation. This study contrib- utes to the literature on quick-acting and effective non- pharmacologic measures for pain reduction.

Limitations There are three significant limitations in the current investigation. First, this study was not double-blind. Re- searchers had information on which child was in which study group. To correct researcher bias, the pain and anxiety levels were not assessed by the researchers.

Second, the parents may have anticipated specific results because they were informed about our hypoth- esis. Thus, placebo effects were not controlled. This could have biased our results by affecting the reports of the parents and the observer reports. Third, the nurse who participated in the study was not selected randomly. This could have influenced the usual care process.

Acknowledgments

The authors acknowledge the participating children and their parents of this study.

REFERENCES

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