- Email: [email protected]
An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial
JBUR-4658; No. of Pages 11 burns xxx (2015) xxx–xxx
Available online at www.sciencedirect.com
ScienceDirect journal homepage: www.elsevier.com/locate/burns
An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial§,§§ Ela J. Hyland a,*, Rachel D’Cruz a, John G. Harvey a,b, Jordyn Moir a,c, Christina Parkinson a,c, Andrew J.A. Holland a,b a
The Children’s Hospital at Westmead Burns Research Institute, The Children’s Hospital at Westmead, Cnr Hawkesbury Rd and Hainsworth St, Westmead, NSW 2145, Australia b Discipline of Paediatrics and Child Health, Sydney Medical School, The University of Sydney, NSW, Australia c The Department of Child Life Therapy, The Children’s Hospital at Westmead, Cnr Hawkesbury Rd and Hainsworth St, Westmead, NSW 2145, Australia
article info
abstract
Article history:
Introduction: Burns remain extremely painful and distressing in young children. The con-
Accepted 26 May 2015
sequences of poorly managed pain and anxiety can be life-long. Whilst Child Life Therapy (CLT) has been shown to be effective in many situations, few studies have looked at the
Keywords:
effectiveness of CLT in regard to reducing pain and anxiety in children undergoing burn
Paediatric
dressing changes.
Child Life Therapy
Methods: A prospective, randomised controlled trial was conducted, comparing CLT versus
Burns
standard care in relation to pain and anxiety scores of children undergoing their initial burn
Pain
dressing change. Pain and anxiety were assessed by an independent observer and ques-
Anxiety
tionnaires completed by the child, parent/caregiver and nursing staff. Results: 50 subjects were recruited in each treatment group; median age 2.3 years (CLT) and 2.2 years (standard care). The median total body surface area (TBSA) burnt was 0.8% (CLT) and 0.5% (standard care). The majority were partial thickness dermal burns (88% CLT, 94% standard care). Rates of parent anxiety and pre-procedural child pain and anxiety were similar. Combined and scaled pain and anxiety scores in the CLT group were significantly less than in the standard treatment group ( p = 0.03). Whilst pain was significantly better in the CLT group ( p = 0.02), fear scores, wound outcomes and the need for skin grafting were not statistically different in either group. Conclusions: The presence of a Child Life Therapist, with their ability to adapt to the environment, the child and their family, significantly reduced the experience of pain during paediatric burn dressings. # 2015 Elsevier Ltd and ISBI. All rights reserved.
§
Universal trial number: U1111-1150-0568. Registration with the Australian and New Zealand Clinical Trials Registry: ACTRN12613001238763. * Corresponding author. Tel.: +61 439424772. E-mail address: [email protected] (E.J. Hyland). Abbreviations: CHEOPS, Children’s Hospital of Eastern Ontario Pain Score; CLT, Child Life Therapy; CLTP, Child Life Therapist; TBSA, total body surface area; IQR, interquartile range. http://dx.doi.org/10.1016/j.burns.2015.05.017 0305-4179/# 2015 Elsevier Ltd and ISBI. All rights reserved.
§§
Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
JBUR-4658; No. of Pages 11
2
burns xxx (2015) xxx–xxx
1.
Introduction
Children’s burns and their treatment can be extremely painful and anxiety provoking [1,2]. The consequences of poorly managed pain and anxiety in children can have life-long consequences [1,3]. Initial management of burn wounds commonly involves wound cleansing, blister debridement and the application of antibacterial dressings. Acute procedural pain associated with burns, such as dressing changes and their associated anticipation [4] has been shown to be the most intense when compared to other types of burn related pain [3,5,6]. Whilst the mainstay of analgesia prior to and during dressing changes remains the use of opioids [1–3,6], non-pharmacological techniques and adjuncts have increasingly been reported in the literature [1,2]. Many specific Child Life Therapy (CLT) (previously known as Play Therapy) techniques or devices have been shown to reduce pain and anxiety experienced by children during procedures [7–9]. Examples of techniques used include music, bubbles, games, electronic devices, and virtual reality [7,9–11]. The role of a Child Life Therapist (CLTP), however, also includes the provision of pre-procedural psychological support, education for parent and child; and procedural support during dressing changes [12]. The presence of a CLTP during burn dressing changes anecdotally results in children feeling much more in control, theoretically reducing stress and the release of stress hormones, reducing their pain and anxiety experience. There have been many studies which have looked at specific devices or techniques to distract children with burns [7,9–11], however very few have looked at the specific role of the CLTP [13,14] and none appear to have done so in burns. We therefore undertook a prospective, randomised controlled trial to compare CLT to standard care (no CLT) in children receiving their initial dressing change in our Burn Unit, to assess whether the presence of a CLTP during children’s initial burns dressings was effective in reducing the level of pain and anxiety they experience compared to those children who do not have a CLTP present.
2.
Methods
2.1.
Ethical considerations
Sydney Children’s Hospitals Human Research Ethics Committee approval was obtained prior to commencement of this study. Signed consent was obtained from parents or guardians prior to enrollment.
2.2.
Inclusion criteria
Children <16 years of age, upon initial presentation to the Burn Unit at The Children’s Hospital at Westmead, Sydney, Australia for a dressing change of their burn were considered for this study.
2.3.
Exclusion criteria
Children were excluded from the study if they or their parents or caregivers had a cognitive impairment, were
non-English speaking or were not able to use the outcome tools.
2.4.
Randomisation
Subjects were randomised in a 1:1 ratio to CLT or standard care (no CLT) using permuted blocks of size 4 and 6. Randomisation was stratified by the child’s age (0–3 years versus 3 years) and the extent of the burn (<1% total body surface area (TBSA) versus 1% TBSA) in order to maintain balance between treatment groups. Randomisation was computer generated and accessed at time of enrollment. Given the nature of the intervention, it was not possible to blind the investigators.
2.5.
Power calculation
A small pilot study of comparing CLT to standard care showed a standard deviation of approximately 7 for the combined total score of nurse-rated pain plus anxiety during treatment. A sample size of 50 subjects per group was determined to provide 80% power at 5% significance level to detect a difference of 4 in this combined score which ranges from 0 for no pain or anxiety to 20 for maximum pain and anxiety.
2.6.
Study procedure and assessment
Children were recruited prior to receiving their first dressing change in our Burn Unit. This may have been on the initial day of injury or up to 5 days post injury, depending on when the referral was made or if the child was managed in a peripheral centre prior to attending our Burn Unit. In most cases children had an initial basic dressing applied in an Emergency Department or by a General Practitioner prior to attending our Burn Unit. Once randomised, demographics and burn information was recorded for all children (Fig. 1). Burn size and depth were assessed clinically by an experienced burns clinician. Prior to the procedure a parent or caregiver undertook a pre-procedure questionnaire rating their expectations of their child’s pain during the procedure, the child’s pain and anxiety prior to the procedure, and their own anxiety prior to the procedure (Appendix 1). All children were assessed by a Burns Anaesthetic Fellow and received standard pre-medication (analgesic anxiolytic) depending on age and medical history. This commonly consisted of the prescription of oral paracetamol (acetaminophen) 15 mg/kg, morphine 0.5–0.7 mg/kg and midazolam 0.3– 0.5 mg/kg, 30–60 min prior to the procedure. Children were then randomised into receiving CLT or the standard care. Standard care included minimal distraction provided by either both or one parent, or sometimes by music, a toy, or electronic device placed in front of the child by a member of nursing staff. All children and their families received minimal education prior to their procedure by medical and nursing staff. Children in the CLT group received pre-procedural age appropriate preparation, parental support and education, and age specific distraction techniques by a qualified CLTP, whom was dedicated to that child and their family preceding and throughout the procedure. Whilst distraction techniques used by CLTP were similar to those provided by nursing staff and
Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
JBUR-4658; No. of Pages 11
3
burns xxx (2015) xxx–xxx
Assessed for eligibility (n=100)
Enrolment
Excluded (n=0)
Initial data collection Data collected: 1. Patient demographics 2. Burn characteristics 3. Pre-procedure survey (parent/carer)
Allocation Stratified (age and %TBSA) and randomised (n=100). Child receives standard pre-medications.
Allocated to intervention (Child Life Therapy) (n=50)
Procedure undertaken and witnessed by independent observer
Allocated control (n=50)
Data collected (n=100): 1. CHEOPS* and Children’s Fear Scale scores at 2 minute intervals 2. Use of extra medications 3. Confounding factors such as parental anxiety, length of procedure, complex procedure or healed burn at presentation
Post-procedure (same day) Data collected: 1. Nursing staff questionnaire (n=100) 2. Parental/carer questionnaire (n=98) 3. Child questionnaire (age 5-10) (n=7) 4. Child questionnaire>10 years (n=6)
Follow-up Data collected (n=100): 1. Need for skin grafting 2. Subsequent wound infection 3. Days to complete epithelisation
Final analysis Analysed (n=100): Excluded from analysis (n=0)
♦
Fig. 1 – CONSORT flow diagram.
parents, and included the use of music, toys, electronic devices, games, and bubbles, these techniques were tailored specifically to that child by a professional whom concentrated their entire attention on the task of providing distraction and easing the distress of the child. All children received customary clinical management of their injuries depending on burn size and depth. Wounds were cleansed with an antiseptic solution, blisters debrided and an antibacterial dressing applied; which was for the majority of cases, Acticoat 7TM (Smith and Nephew, Hull, England).
During the procedure an independent trained assessor recorded pain and anxiety scores of the child at two minutely intervals using the Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS) [15] and the Children’s Fear Scale [16] (Appendix 2). The use of unplanned analgesia or sedation during the procedure, as assessed and prescribed by the Burns Anaesthetic Fellow (e.g. nitrous oxide [maximum 70%] or intranasal fentanyl [1.5 mg/kg, 5 minutely until effect]), was recorded. Variables such as the length of the procedure, the presence of a healed burn on initial presentation, complex
Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
JBUR-4658; No. of Pages 11
4
burns xxx (2015) xxx–xxx
procedures (e.g. exercises, splinting or Laser Doppler Imaging), or highly anxious parents were noted. Post-procedure, children, parents/caregivers and nursing staff were asked to rate how they felt the procedure went, using combinations of the Wong Baker Faces Scale [17], a Visual Analogue Scale and by rating pain and anxiety from 0 to 10, where zero equals no pain or anxiety and ten equalling the worst pain or anxiety experienced (Appendix 3). All children subsequently received standard clinical care of their burns, which may have included skin grafting. Time to complete re-epithelisation (as clinically determined), wound infections (moderate - heavy colonisation on semi-quantitative wound swab or clinical evidence of infection) and the utilisation for skin grafting were subsequently recorded.
3.
Results
3.1.
Subject characteristics
The aim of this study was to determine how effective CLT (including pre- and intra-procedural support) was at reducing pain and anxiety in children throughout their initial treatment, as assessed by an independent trained assessor, using the CHEOPS [15] and Children’s Fear Scale [16]. Scaled average scores for both pain and anxiety were calculated and their sum used as the primary outcome measure.
There were 100 subjects recruited to the study, with 50 allocated to each treatment group. There were no statistically significant differences between either group. The median age in the CLT group was 2.3 years versus 2.2 years in the standard treatment group (Fig. 2). Mechanisms of injury were similar in both groups, with both scald and contact burns highly prevalent. The majority of injuries in both groups were to hands. The median percentage total body surface area (TBSA) was small in both groups (CLT 0.8% TBSA, and standard care 0.5% TBSA). The majority of injuries were partial thickness dermal burns, with very few full thickness injuries. All children received analgesia prior to their procedure, although the majority (CLT 78%; standard care 68%) received both analgesia and an anxiolytic. The majority of children in both groups (CLT 88%; standard care 90%) had previously visited a hospital, however only 56% in the CLT group and 64% in the standard care group had a prior procedure in hospital. One child in each group had previously worked with a CLTP (Table 1).
2.8.
3.2.
2.7.
Primary outcome
Secondary outcomes
Secondary outcomes included the use of any sedation or pain relief during the procedure: staff, parent and child rated pain and anxiety scores recorded immediately after the procedure and rating of the effectiveness of the therapy in the CLT group. Assessment of the number of days to complete wound reepithelialisation, the need for skin grafting and the development of infection was also undertaken.
2.9.
Statistical analysis
As continuous outcomes had skewed distributions, treatment groups were compared using the Wilcoxin rank sum test. Categorical outcomes were compared between groups using a chi-square test. A p-value of 0.05 was considered statistically significant.
Pre-procedural questionnaire
Prior to the procedure, parents/caregivers were asked to complete a questionnaire relating to their expectations of pain and anxiety experienced by their child during the procedure. Similar results were noted in both groups. Their own levels of anxiety was rated by parent/caregivers and noted as relatively high in both groups. Parents were also asked to rate their child’s current pain and anxiety levels (0–10) prior to the procedure. These were also very similar in both groups (Table 2).
3.3.
Procedural variables
There were multiple variables associated with each dressing change. The median length of the procedure was 16 min in both groups. Fewer children in the CLT received additional
Fig. 2 – Children’s ages. Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
JBUR-4658; No. of Pages 11
5
burns xxx (2015) xxx–xxx
Table 1 – Subject characteristics.
Median age (years) % Male Mechanism
Location of injury (majority)
Scald Contact Friction Flame Electrical Hand
Head/neck Upper limb (excl. hand) Lower limb Torso Median % TBSA Depth of injury
Dermal Full thickness Mixed Analgesia + Premedication anxiolytic Analgesia only Previous hospital visit First procedure in hospital Previous involvement with a Child Life Therapist
Table 3 – Procedure variables. Child Life Therapy (n = 50)
Standard care (n = 50)
2.3 (IQR 1.5–4.5) 25 (50%) 21 (42%) 21 (42%) 5 (10%) 2 (4%) 0 21 (42%)
2.2 (IQR 1.6–3.9) 27 (54%) 29 (58%) 16 (32%) 4 (8%) 1 (2%) 1 (2%) 15 (30%)
7 (14%) 7 (14%) 6 (12%) 9 (18%) 0.8% (IQR 0.5–2.0) 44 (88%) 0% 6 (12%) 39 (78%) 11 44 22 1
(22%) (88%) (44%) (2%)
Standard care (n = 50)
16 (IQR 10–26)
16 (IQR 12–22)
6 (12%)
9 (18%)
7 (IQR 6–8)
6 (IQR 5–7)
8 (16%) 4 (8%)
8 (16%) 6 (12%)
16 (32%)
21 (42%)
9 (18%) 13 (26%) 9 (18%) 4 (8%) 0.5% (IQR 0.5–2.0) 47 (94%) 1 (2%) 2 (4%) 34 (68%) 16 45 18 1
(32%) (90%) (36%) (2%)
analgesic medications, including nitrous oxide or intranasal fentanyl than the standard care group, with 6 subjects in the CLT group and 9 in the standard care group receiving additional medications. The median number of persons in the procedure room during the dressing was similar (7 in the CLT group and 6 in the standard care group). Highly anxious parents/caregivers were noted in 8 cases in both groups. 4 children were healed at their initial dressing change in the CLT group, versus 6 in the standard care group. Complex or lengthy procedures occurred in 16 cases in the CLT group and 21 in the standard care group (Table 3).
3.4.
Median length of procedure (min) Number of children who received extra medications Median number of people in procedure room Highly anxious parent Healed burn at initial dressing change Complex or lengthy procedure
Child Life Therapy (n = 50)
Intra-procedure pain and anxiety scores
Defined as our primary outcome, independently observed and rated, combined and scaled pain and anxiety scores were statistically better in the CLT group (CLT 1.7 versus standard care 2.9; p = 0.03). The median CHEOPS [15] pain score observed was significantly less in the CLT group ( p = 0.02), however there was no significant difference in fear scores ( p = 0.3).
Median CHEOPS [15] and Children’s Fear Scale [16] scores were the same in both groups at the beginning and the end of each procedure (Table 4).
3.5.
Post-procedural assessment
Post-procedure nursing staff, children and parents/caregivers were asked to complete questionnaires regarding pain and anxiety. There was limited child completion if questionnaires, likely due to the effects of sedation, analgesia or distress, such that we were unable to report their results. Nursing staff reported median scores (0–10) of 2.0 for both pain and anxiety experienced by children during the procedure in both groups, however rated the median effectiveness of CLT (0–10), in those children who received it, 9.0 (0–10, Table 5). The median parent/caregiver anxiety (0–10) experienced during the procedure was higher in the CLT group (CLT 5.0 versus standard care 3.5). In contrast parents/caregivers rated their child’s pain and anxiety, lower in the CLT group (CLT pain 2.0 versus standard care pain 3.0; CLT anxiety 3.0 versus standard care anxiety 4.3). Like the nursing staff, parents/ caregivers rated the effectiveness of CLT as 9.0 (0–10, Table 6).
3.6.
Wound outcomes
There was no significant difference between the rate of wound infections ( p = 0.5), skin grafting ( p = 0.3), or days to complete epithelisation ( p = 1) between either group (Table 7).
4.
Discussion
The role of a CLTP has become instrumental in the paediatric burns multidisciplinary team [18]. It has been well established
Table 2 – Results of pre-procedure parent/caregiver questionnaire. Child Life Therapy (n = 50) Parent/caregiver Parent/caregiver Parent/caregiver Parent/caregiver
expectation of child’s pain during dressing (median) (0–10) anxiety prior to procedure (median) (0–10) rated child pain prior to procedure (median) (0–10) rated child anxiety prior to procedure median (0–10)
7.0 7.0 3.5 2.0
(IQR (IQR (IQR (IQR
5.0–8.0) 5.0–8.0) 0.0–4.0) 1.0–5.0)
Standard care (n = 50) 6.3 6.0 3.0 2.0
(IQR (IQR (IQR (IQR
5.0–8.0) 4.0–8.0) 0.0–5.0) 0.0–5.0)
Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
JBUR-4658; No. of Pages 11
6
burns xxx (2015) xxx–xxx
Table 4 – Pain and anxiety scores.
Average, combined and scaled fear and pain scores 0–20 (median) Average CHEOPS pain score 4–13 (median) CHEOPS score at start of procedure 4–13 (median) CHEOPS score at end of procedure 4–13 (median) Average fear score 1–5 (median) Fear score at start of procedure 1–5 (median) Fear score at end of procedure 1–5
Child Life Therapy (n = 50)
Standard care (n = 50)
1.7 (IQR 0.6–4.5)
2.9 (IQR 1.9–5.7)
0.1–1.8
0.03
5.3 5.0 5.0 1.2 1.0 1.0
6.0 5.0 5.0 1.3 1.0 1.0
0.1–1.2
0.02
(IQR (IQR (IQR (IQR (IQR (IQR
4.5–6.7) 4.0–6.0) 4.0–6.0) 1.0–1.6) 1.0–1.0) 1.0–1.0)
(IQR (IQR (IQR (IQR (IQR (IQR
5.4–7.6) 5.0–6.0) 4.0–6.0) 1.0–1.7) 1.0–1.0) 1.0–1.0)
95% confidence limits
0–0.2
p-value
0.3
Table 5 – Staff assessment. Child Life Therapy (n = 50) Child anxiety prior to procedure 0–10 (median) Child anxiety during procedure 0–10 (median) Child pain prior to procedure 0–10 (median) Child pain during procedure 0–10 Effectiveness of Child Life Therapy 0–10 (median)
2.0 2.0 1.0 2.0 9.0
(IQR (IQR (IQR (IQR (IQR
Standard care (n = 50)
0.0–4.0) 0.0–5.0) 0.0–2.0) 0.0–4.0) 8.0–10.0)
1.5 (IQR 0.0–3.0) 2.0 (IQR 1.0–7.0) 0.5 (IQR 0.0–1.0) 2.0 (IQR 0.0–5.0) Not applicable
Table 6 – Parent/caregiver assessment. Child Life Therapy (n = 50) Parent anxiety during the procedure 0–10 (median) Child’s anxiety during the procedure 0–10 (median) Child’s pain during procedure 0–10 (median) Effectiveness of Child Life Therapy 0–10 (median)
5.0 3.0 2.0 9.0
(IQR (IQR (IQR (IQR
Standard care (n = 50)
1.0–7.0) 1.0–6.0) 0.0–4.0) 9.0–10.0)
3.5 (IQR 2.0–7.5) 4.3 (IQR 1.0–8.0) 3.0 (IQR 1.0–7.0) Not applicable
Table 7 – Wound outcomes.
Wound infection Received skin grafting Days to healing (median)
Child Life Therapy (n = 50)
Standard care (n = 50)
3 (6%) 9 (18%) 11.5 (IQR 8.0–18.0)
5 (10%) 13 (26%) 12.0 (IQR 7.0–21.0)
that the use of distraction during medical procedures significantly reduces pain and anxiety experienced by children [9,19]. There have been multiple studies confirming the effectiveness of specific CLT devices and techniques in burns; for example virtual reality, music therapy, or use of the DittoTM device (Diversional Therapy Technologies, Brisbane, Australia) [7,10,11,20–23]. In our Burn Unit, not only have we found that specific techniques and devices appear beneficial, but the role of a CLTP has anecdotally also had a significant impact on the reduction of pain and anxiety experienced by children with acute burns. Unlike static techniques, electronic devices, or distraction provided by parents, who are often as distressed as the child, CLTP can easily adapt to fluctuating changes in the environment, provide age and procedure appropriate distraction and provide pre-procedural preparation adapted for the child, their family and their past experiences [12]. Using techniques attributed to psychological therapies such as Cognitive Behavioural Therapy [8,24], CLTP can assist in thought restructuring: for example via emphasising whilst pain ‘‘hurts’’ it does not ‘‘harm’’ [5]. Psychological therapies described in the literature and used by CLTP may include those of cognitive, preparatory, behavioural or distraction techniques [6,25].
95% confidence limits
p-value
3.0–3.0
0.5 0.3 1
Burns and their treatment can be extremely painful. Children may become especially distressed and anxious due to their immaturity, prior experiences and poor coping strategies [1,2,26–28]. Procedural pain associated with acute burns, such as dressing changes, in contrast to other types of burn related pain, has been shown to be significant and perhaps exacerbated by anticipation and fear of the unknown [3,5,6,29]. Poorly managed pain and anxiety during acute burn management has been shown to increase the incidence of subsequent psychological disorders, including post-traumatic stress disorder [2,7,26,29–32]. In addition to emotional distress and potential psychological harm, the pathophysiological response to pain and anxiety, leading to release of stress hormones such as cortisol [33], could also potentially impact wound healing [34]. Unfortunately, whilst burn pain and anxiety have been shown to have many adverse effects, they continue to often be poorly managed [3,35]. Any method which reduces pain and anxiety in acutely burnt children should therefore be considered in standard practice. Pain associated with burns is thought to derive from direct noxious chemical and mechanical stimulation, and damage of peripheral nociceptors with proceeding central sensitisation [6]. Cytokines, such as interleukin-6, released in response to burns can also be significant mediators of pain [36]. Not only
Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
JBUR-4658; No. of Pages 11 burns xxx (2015) xxx–xxx
does pain have significant psychological impacts upon burn injured children [2,7,32], it may also be associated with significant pathophysiological adverse outcomes, contribute to burn hypermetabolism and if poorly treated has been hypothesised to lead to more morbidity and mortality associated with burns [37]. One aspect of Melzack and Wall’s Gate Control Theory of pain suggests that as the mind has the ability to cope with limited amounts of information at any one time [38], therefore distraction provided by CLT would seem likely to be highly effective in reducing the experience of pain [10]. A child focused on pain may suffer an increased pain experience, whereas a child distracted, may experience reduced levels of pain [39]. Distraction provided by nursing and medical staff is often ad hoc, intermittent and may refocus the child on the painful procedure being undertaken due to staff members returning to the prescribed task. CLTPs, however, would be able to focus their complete attention on the child, providing uninterrupted distraction throughout the procedure [39], and would therefore be capable of blunting the pain experience [38]. Our results remain consistent with this theory, as a significant reduction was found in those children exposed to CLT, as rated by an independent observer. Depending on %TBSA effected, acute burns cause significant stress responses via neurohumoural dysregulation, massive sympathetic outflow and the pathological release of cytokines and stress hormones such as cortisol [1,33]. It has been hypothesised that stress related dysfunction of the hypothalamic–pituitary axis leads to significant influences on brain development and may have a lifelong impact on anxiety and coping strategies [1]. It has been well established that poorly managed pain and anxiety during acute burn procedures can lead to post-traumatic stress disorder, development of antisocial behaviour and sleep disturbance [3,30]. Our results indicate that the use of a CLT did not alter the level of anxiety or stress experienced by children in our study. The study was limited by the subjective measures we have employed and salivary cortisol levels may have been a beneficial objective measure of stress [11,40]. Wound healing, rates of infection and the need for skin grafting were similar in both groups, however, which supports our finding of similar levels of stress and anxiety experienced by the children in our study. Parental presence can alter pain and anxiety experiences dramatically. Studies have shown that parental presence reduces the amount of distress experienced by children during painful procedures [28,41]. Parents may, however, worsen a child’s distress if they express high levels of anxiety and agitation themselves [42]. One of the roles of a CLT has been to work with the whole family, training parents in techniques to manage their own anxiety and to assist them in encouraging coping strategies for their child [41]. Despite this, we found that levels of observed parental anxiety were similar in both groups, and interestingly parent rated anxiety levels were higher in the CLT group. An explanation for this finding could be that majority of parents are highly anxious during their child’s initial presentation to our Burn Unit. This anxiety is often exacerbated by feelings of guilt. It is likely, however, that over multiple visits a positive relationship would develop between the therapist, the child and their family and that the
7
benefits of CLT would negate the psychological and physiological harm associated with stress and pain of burns. Several parents commented during subsequent visits to our Burn Unit that the relationship that their child developed with the CLTP over several visits had a positive effect on their child’s level of pain and anxiety. Unfortunately, our study was limited to the initial dressing experience in our Burn Unit as there would have been multiple confounders associated with healing burns upon subsequent visits. Therefore the potential benefits of continuity of care were not validated. All children with burns remain unique and differ in their response to CLT [43]. Pain and anxiety continue to be subjective and individual experiences that remain difficult to analyse and quantify, especially in children [44,45]. Whilst advances in pain scales may have assisted in the analysis of pain in children [46,47], toddlers, who make the large majority of children whom we treat in our Burn Unit, are usually non- or minimally verbal. For some children pain or distress may resemble bad behaviour or emotional lability. Children are often not able to express their pain or distress in a meaningful way and manifestations of pain and anxiety may be difficult to interpret and quantify. Therefore despite the many assessment tools available to assess pain and anxiety in children, any study which analyses such outcomes in children remains fraught with potential difficulty.
5.
Conclusion
This randomised controlled trial found that the presence of a CLTP during initial burn dressing changes in our Burn Unit reduced the amount of pain experienced by children. Whilst our study did not find a reduction in children’s fear scores during initial dressing changes, it is likely that over subsequent visits a rapport with the CLTP would develop and distress reduce. Better management of childhood pain and anxiety is likely to reduce the potential risk of devastating and life long consequences of poorly managed pain and anxiety. It is likely that the ability of CLTPs to adapt to environmental changes associated with burns dressings, provide patient and family tailored distraction, and their ability to build relationships with the child and their family to provide continuity of care provides a higher quality of pain and anxiety management than the intermittent use of ad hoc toys and games by non-CLTPs.
Author’s contributions EJH, RDC, CP, JGH and AJAH designed the study; EJH, CP and JM conducted the literature review; EJH and AJAH were involved in writing the manuscript; and JGH and AJAH critically appraised the draft manuscript. All authors approved the final manuscript.
Conflicts of interest The authors declare no conflicts of interest. A paid independent observer was employed to undertake data collection.
Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
JBUR-4658; No. of Pages 11
8
burns xxx (2015) xxx–xxx
Acknowledgements We would like to acknowledge the contribution of Biostatistician Elizabeth Barnes from the University of Sydney. We
would also like to acknowledge the hard work of Karen Weir for her significant contribution to this study. Finally, we would like to thank the children and their families involved in this study, their instrumental assistance and commitment was greatly appreciated.
Appendix 1. Pre-procedural pain and anxiety questionnaire
Parent/caregiver: How painful do you expect the procedure to be? How anxious are you BEFORE the procedure? Your child’s anxiety level BEFORE the procedure Your child’s pain level BEFORE the procedure
0–10 (10 = maximal) 0–10 0–10 0–10
Appendix 2. Intra-procedural tools used by independent observer to rate pain and anxiety 1. Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS) [15]
Parameter
Finding
Explanation
Points
Cry
No cry Moaning Crying Screaming Smiling Composed Grimace Positive None Complaints other than pain Pain complaints Both pain and non-pain complaints Neutral Shifting Tense Shivering Upright Restrained Not touching Reach Touch Grab Restrained Neutral Squirming Drawn up tensed Standing Restrained
Child is not crying Moaning or silent cry Gentle or whimpering cry Full lunged cry, sobbing Positive facial expression Neutral facial expression Negative facial expression Talks without complaint Not talking e.g. ‘‘I want Mummy, I am thirsty’’
1 2 2 3 0 1 2 0 1 1 2 2 1 2 2 2 2 2 1 2 2 2 2 1 2 2 2 2
Facial
Child Verbal
Torso
Touch
Legs
Body is at rest, torso is inactive Body is arched or rigid Shuddering or shaking involuntarily Vertical Not touching wound Reaching for but not touching wound Gently touching wound Grabbing vigorously at wound Child’s arms are restrained Legs are relaxed Uneasy, restless movements, striking out with foot Legs tensed and pulled up near body
Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
JBUR-4658; No. of Pages 11
9
burns xxx (2015) xxx–xxx
2. Children’s Fear Scale [16]
Appendix 3. Post-procedural measures of pain and anxiety
Parent/caregiver: How anxious were you DURING the procedure? Your child’s anxiety level DURING the procedure Your child’s pain level DURING the procedure If Child Life Therapist was present: How effective do you think Child Life Therapy was in reducing your child’s PAIN and ANXIETY? (0 – no effect ! 10 – very effective)
0–10 (10 = maximal) 0–10 0–10
Child 5–10 years:
1. Wong Baker Faces Pain Scale [17]
2. Children’s Fear Scale [16] Young person 10 years:
1. Visual Analogue Pain scale 0–10 (10 = maximal pain) 2. Children’s Fear Scale [16]
Nursing staff: The child’s anxiety level BEFORE the procedure The child’s anxiety level DURING the procedure The child’s pain level BEFORE the procedure The child’s pain level DURING the procedure If Child Life Therapist was present: How effective do you think Child Life Therapy was in reducing the child’s PAIN and ANXIETY? (0 – no effect ! 10 – very effective)
0–10 (10 = maximal) 0–10 0–10 0–10
Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
JBUR-4658; No. of Pages 11
10
burns xxx (2015) xxx–xxx
references
[1] Stoddard FJ, Sheridan RL, Saxe GN, King BS, King BH, Chedekel DS, et al. Treatment of pain in acutely burned children. J Burn Care Rehabil 2002;23:135–56. [2] Gandhi M, Thomson C, Lord D, Enoch S. Management of pain in children with burns. Int J Pediatr 2010;2010. [3] Richardson P, Mustard L. The management of pain in the burns unit. Burns 2009;35:921–36. [4] Winskill R, Andrews D. Minimizing the ‘ouch’ – a strategy to minimize pain, fear and anxiety in children presenting to the emergency department. Australas Emerg Nurs J 2008;11:184–8. [5] Patterson DR, Hofland HW, Espey K, Sharar S. Nursing Committee of the International Society for Burn. I. Pain management. Burns 2004;30:A10–5. [6] Abdi S, Zhou Y. Management of pain after burn injury. Curr Opin Anaesthesiol 2002;15:563–7. [7] Hanson MD, Gauld M, Wathen CN, Macmillan HL. Nonpharmacological interventions for acute wound care distress in pediatric patients with burn injury: a systematic review. J Burn Care Res 2008;29:730–41. [8] Anderson Khan K, Weisman S. Nonpharmacologic pain management strategies in the pediatric emergency department. Clin Pediatr Emerg Med 2007;8:240–7. [9] Koller D, Goldman RD. Distraction techniques for children undergoing procedures: a critical review of pediatric research. J Pediatr Nurs 2012;27:652–81. [10] Tan X, Yowler CJ, Super DM, Fratianne RB. The efficacy of music therapy protocols for decreasing pain, anxiety, and muscle tension levels during burn dressing changes: a prospective randomized crossover trial. J Burn Care Res 2010;31:590–7. [11] Brown NJ, Kimble RM, Rodger S, Ware RS, Cuttle L. Play and heal: randomized controlled trial of Ditto intervention efficacy on improving re-epithelialization in pediatric burns. Burns 2014;40:204–13. [12] Committee On Hospital Care and Child Life Council. Child life services. Pediatrics 2014;133:e1471–8. [13] Tyson ME, Bohl DD, Blickman JG. A randomized controlled trial: child life services in pediatric imaging. Pediatr Radiol 2014;44:1426–32. [14] 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. J Pediatr Oncol Nurs 2007;24:8–19. [15] McGrath P, Johnston G, Goodman JT. CHEOPS: a behavioral scale for rating postoperative pain in children. In: Fields H, Dubner R, Cervero F, editors. Proceeding of the 4th world congress on pain: advances in pain research and therapy. New York, USA: Raven Press; 1985. p. 395–401. [16] McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children’s fear during procedural pain: preliminary investigation of the children’s fear scale. Health Psychol 2011;30:780–8. [17] Wong DL, Baker CM. Smiling faces as anchor for pain intensity scales. Pain 2001;89:295–300. [18] D’Cruz R, Martin HC, Holland AJ. Medical management of paediatric burn injuries: best practice part 2. J Paediatr Child Health 2013. [19] Kleiber C, Harper DC. Effects of distraction on children’s pain and distress during medical procedures: a metaanalysis. Nurs Res 1999;48:44–9. [20] Jeffs D, Dorman D, Brown S, Files A, Graves T, Kirk E, et al. Effect of virtual reality on adolescent pain during burn wound care. J Burn Care Res 2014;35:395–408.
[21] Schmitt YS, Hoffman HG, Blough DK, Patterson DR, Jensen MP, Soltani M, et al. A randomized, controlled trial of immersive virtual reality analgesia, during physical therapy for pediatric burns. Burns 2011;37:61–8. [22] Das DA, Grimmer KA, Sparnon AL, McRae SE, Thomas BH. The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: a randomized controlled trial [ISRCTN87413556]. BMC Pediatr 2005;5:1. [23] Miller K, Rodger S, Bucolo S, Greer R, Kimble RM. Multimodal distraction, using technology to combat pain in young children with burn injuries. Burns 2010;36:647–58. [24] American Academy of Pediatrics Child Life Council and Committee on Hospital Care, Wilson JM. Child life services. Pediatrics 2006;118:1757–63. [25] Patterson DR. Practical applications of psychological techniques in controlling burn pain. J Burn Care Rehabil 1992;13:13–8. [26] Stoddard FJ. Coping with pain: a developmental approach to treatment of burned children. Am J Psychiatry 1982;139:736–40. [27] Blount R. The influence of environmental factors and coping style on children’s coping and distress. Clin Psychol Rev 1991;11:93–116. [28] Dise-Lewis JE. A developmental perspective on psychological principles of burn care. J Burn Care Rehabil 2001;22:255–60. [29] Elliott CH, Olson RA. The management of children’s distress in response to painful medical treatment for burn injuries. Behav Res Ther 1983;21:675–83. [30] Taal LA, Faber AW. Burn injuries, pain and distress: exploring the role of stress symptomatology. Burns 1997;23:288–90. [31] Stoddard FJ, Norman DK, Murphy JM, Beardslee WR. Psychiatric outcome of burned children and adolescents. J Am Acad Child Adolesc Psychiatry 1989;28:589–95. [32] Browne AL, Andrews R, Schug SA, Wood F. Persistent pain outcomes and patient satisfaction with pain management after burn injury. Clin J Pain 2011;27:136–45. [33] Brown NJ, Kimble RM, Rodger S, Ware RS, McWhinney BC, Ungerer JP, et al. Biological markers of stress in pediatric acute burn injury. Burns 2014;40:887–95. [34] Brown NJ, Kimble RM, Gramotnev G, Rodger S, Cuttle L. Predictors of re-epithelialization in pediatric burn. Burns 2014;40:751–8. [35] Summer GJ, Puntillo KA, Miaskowski C, Green PG, Levine JD. Burn injury pain: the continuing challenge. J Pain 2007;8:533–48. [36] Summer GJ, Romero-Sandoval EA, Bogen O, Dina OA, Khasar SG, Levine JD. Proinflammatory cytokines mediating burn-injury pain. Pain 2008;135:98–107. [37] Latarjet J, Choinere M. Pain in burn patients. Burns 1995;21:344–8. [38] Melzack R, Wall PD. Pain mechanisms: a new theory. Science 1965;150:971–9. [39] Beales JG. Factors influencing the expectation of pain among patients in a children’s burns unit. Burns Incl Therm Inj 1983;9:187–92. [40] Sudhaus S, Held S, Schoofs D, Bultmann J, Duck I, Wolf OT, et al. Associations between fear-avoidance and endurance responses to pain and salivary cortisol in the context of experimental pain induction. Psychoneuroendocrinology 2014;52C:195–9. [41] Bachanas PJ, Blount RL. The behavioral approachavoidance and distress scale: an investigation of reliability and validity during painful medical procedures. J Pediatr Psychol 1996;21:671–81. [42] Penner LA, Cline RJ, Albrecht TL, Harper FW, Peterson AM, Taub JM, et al. Parents’ empathic responses and pain and distress in pediatric patients. Basic Appl Soc Psychol 2008;30:102–13.
Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
JBUR-4658; No. of Pages 11 burns xxx (2015) xxx–xxx
[43] Nilsson S, Renning AC. Pain management during wound dressing in children. Nurs Stand 2012;26:50–5. [44] von Baeyer CL. Children’s self-reports of pain intensity: scale selection, limitations and interpretation. Pain Res Manag 2006;11:157–62. [45] Stanford EA, Chambers CT, Craig KD. The role of developmental factors in predicting young children’s use of a self-report scale for pain. Pain 2006;120:16–23.
11
[46] Ratcliff SL, Brown A, Rosenberg L, Rosenberg M, Robert RS, Cuervo LJ, et al. The effectiveness of a pain and anxiety protocol to treat the acute pediatric burn patient. Burns 2006;32:554–62. [47] Kelly AM, Powell CV, Williams A. Parent visual analogue scale ratings of children’s pain do not reliably reflect pain reported by child. Pediatr Emerg Care 2002;18: 159–62.
Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
Available online at www.sciencedirect.com
ScienceDirect journal homepage: www.elsevier.com/locate/burns
An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial§,§§ Ela J. Hyland a,*, Rachel D’Cruz a, John G. Harvey a,b, Jordyn Moir a,c, Christina Parkinson a,c, Andrew J.A. Holland a,b a
The Children’s Hospital at Westmead Burns Research Institute, The Children’s Hospital at Westmead, Cnr Hawkesbury Rd and Hainsworth St, Westmead, NSW 2145, Australia b Discipline of Paediatrics and Child Health, Sydney Medical School, The University of Sydney, NSW, Australia c The Department of Child Life Therapy, The Children’s Hospital at Westmead, Cnr Hawkesbury Rd and Hainsworth St, Westmead, NSW 2145, Australia
article info
abstract
Article history:
Introduction: Burns remain extremely painful and distressing in young children. The con-
Accepted 26 May 2015
sequences of poorly managed pain and anxiety can be life-long. Whilst Child Life Therapy (CLT) has been shown to be effective in many situations, few studies have looked at the
Keywords:
effectiveness of CLT in regard to reducing pain and anxiety in children undergoing burn
Paediatric
dressing changes.
Child Life Therapy
Methods: A prospective, randomised controlled trial was conducted, comparing CLT versus
Burns
standard care in relation to pain and anxiety scores of children undergoing their initial burn
Pain
dressing change. Pain and anxiety were assessed by an independent observer and ques-
Anxiety
tionnaires completed by the child, parent/caregiver and nursing staff. Results: 50 subjects were recruited in each treatment group; median age 2.3 years (CLT) and 2.2 years (standard care). The median total body surface area (TBSA) burnt was 0.8% (CLT) and 0.5% (standard care). The majority were partial thickness dermal burns (88% CLT, 94% standard care). Rates of parent anxiety and pre-procedural child pain and anxiety were similar. Combined and scaled pain and anxiety scores in the CLT group were significantly less than in the standard treatment group ( p = 0.03). Whilst pain was significantly better in the CLT group ( p = 0.02), fear scores, wound outcomes and the need for skin grafting were not statistically different in either group. Conclusions: The presence of a Child Life Therapist, with their ability to adapt to the environment, the child and their family, significantly reduced the experience of pain during paediatric burn dressings. # 2015 Elsevier Ltd and ISBI. All rights reserved.
§
Universal trial number: U1111-1150-0568. Registration with the Australian and New Zealand Clinical Trials Registry: ACTRN12613001238763. * Corresponding author. Tel.: +61 439424772. E-mail address: [email protected] (E.J. Hyland). Abbreviations: CHEOPS, Children’s Hospital of Eastern Ontario Pain Score; CLT, Child Life Therapy; CLTP, Child Life Therapist; TBSA, total body surface area; IQR, interquartile range. http://dx.doi.org/10.1016/j.burns.2015.05.017 0305-4179/# 2015 Elsevier Ltd and ISBI. All rights reserved.
§§
Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
JBUR-4658; No. of Pages 11
2
burns xxx (2015) xxx–xxx
1.
Introduction
Children’s burns and their treatment can be extremely painful and anxiety provoking [1,2]. The consequences of poorly managed pain and anxiety in children can have life-long consequences [1,3]. Initial management of burn wounds commonly involves wound cleansing, blister debridement and the application of antibacterial dressings. Acute procedural pain associated with burns, such as dressing changes and their associated anticipation [4] has been shown to be the most intense when compared to other types of burn related pain [3,5,6]. Whilst the mainstay of analgesia prior to and during dressing changes remains the use of opioids [1–3,6], non-pharmacological techniques and adjuncts have increasingly been reported in the literature [1,2]. Many specific Child Life Therapy (CLT) (previously known as Play Therapy) techniques or devices have been shown to reduce pain and anxiety experienced by children during procedures [7–9]. Examples of techniques used include music, bubbles, games, electronic devices, and virtual reality [7,9–11]. The role of a Child Life Therapist (CLTP), however, also includes the provision of pre-procedural psychological support, education for parent and child; and procedural support during dressing changes [12]. The presence of a CLTP during burn dressing changes anecdotally results in children feeling much more in control, theoretically reducing stress and the release of stress hormones, reducing their pain and anxiety experience. There have been many studies which have looked at specific devices or techniques to distract children with burns [7,9–11], however very few have looked at the specific role of the CLTP [13,14] and none appear to have done so in burns. We therefore undertook a prospective, randomised controlled trial to compare CLT to standard care (no CLT) in children receiving their initial dressing change in our Burn Unit, to assess whether the presence of a CLTP during children’s initial burns dressings was effective in reducing the level of pain and anxiety they experience compared to those children who do not have a CLTP present.
2.
Methods
2.1.
Ethical considerations
Sydney Children’s Hospitals Human Research Ethics Committee approval was obtained prior to commencement of this study. Signed consent was obtained from parents or guardians prior to enrollment.
2.2.
Inclusion criteria
Children <16 years of age, upon initial presentation to the Burn Unit at The Children’s Hospital at Westmead, Sydney, Australia for a dressing change of their burn were considered for this study.
2.3.
Exclusion criteria
Children were excluded from the study if they or their parents or caregivers had a cognitive impairment, were
non-English speaking or were not able to use the outcome tools.
2.4.
Randomisation
Subjects were randomised in a 1:1 ratio to CLT or standard care (no CLT) using permuted blocks of size 4 and 6. Randomisation was stratified by the child’s age (0–3 years versus 3 years) and the extent of the burn (<1% total body surface area (TBSA) versus 1% TBSA) in order to maintain balance between treatment groups. Randomisation was computer generated and accessed at time of enrollment. Given the nature of the intervention, it was not possible to blind the investigators.
2.5.
Power calculation
A small pilot study of comparing CLT to standard care showed a standard deviation of approximately 7 for the combined total score of nurse-rated pain plus anxiety during treatment. A sample size of 50 subjects per group was determined to provide 80% power at 5% significance level to detect a difference of 4 in this combined score which ranges from 0 for no pain or anxiety to 20 for maximum pain and anxiety.
2.6.
Study procedure and assessment
Children were recruited prior to receiving their first dressing change in our Burn Unit. This may have been on the initial day of injury or up to 5 days post injury, depending on when the referral was made or if the child was managed in a peripheral centre prior to attending our Burn Unit. In most cases children had an initial basic dressing applied in an Emergency Department or by a General Practitioner prior to attending our Burn Unit. Once randomised, demographics and burn information was recorded for all children (Fig. 1). Burn size and depth were assessed clinically by an experienced burns clinician. Prior to the procedure a parent or caregiver undertook a pre-procedure questionnaire rating their expectations of their child’s pain during the procedure, the child’s pain and anxiety prior to the procedure, and their own anxiety prior to the procedure (Appendix 1). All children were assessed by a Burns Anaesthetic Fellow and received standard pre-medication (analgesic anxiolytic) depending on age and medical history. This commonly consisted of the prescription of oral paracetamol (acetaminophen) 15 mg/kg, morphine 0.5–0.7 mg/kg and midazolam 0.3– 0.5 mg/kg, 30–60 min prior to the procedure. Children were then randomised into receiving CLT or the standard care. Standard care included minimal distraction provided by either both or one parent, or sometimes by music, a toy, or electronic device placed in front of the child by a member of nursing staff. All children and their families received minimal education prior to their procedure by medical and nursing staff. Children in the CLT group received pre-procedural age appropriate preparation, parental support and education, and age specific distraction techniques by a qualified CLTP, whom was dedicated to that child and their family preceding and throughout the procedure. Whilst distraction techniques used by CLTP were similar to those provided by nursing staff and
Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
JBUR-4658; No. of Pages 11
3
burns xxx (2015) xxx–xxx
Assessed for eligibility (n=100)
Enrolment
Excluded (n=0)
Initial data collection Data collected: 1. Patient demographics 2. Burn characteristics 3. Pre-procedure survey (parent/carer)
Allocation Stratified (age and %TBSA) and randomised (n=100). Child receives standard pre-medications.
Allocated to intervention (Child Life Therapy) (n=50)
Procedure undertaken and witnessed by independent observer
Allocated control (n=50)
Data collected (n=100): 1. CHEOPS* and Children’s Fear Scale scores at 2 minute intervals 2. Use of extra medications 3. Confounding factors such as parental anxiety, length of procedure, complex procedure or healed burn at presentation
Post-procedure (same day) Data collected: 1. Nursing staff questionnaire (n=100) 2. Parental/carer questionnaire (n=98) 3. Child questionnaire (age 5-10) (n=7) 4. Child questionnaire>10 years (n=6)
Follow-up Data collected (n=100): 1. Need for skin grafting 2. Subsequent wound infection 3. Days to complete epithelisation
Final analysis Analysed (n=100): Excluded from analysis (n=0)
♦
Fig. 1 – CONSORT flow diagram.
parents, and included the use of music, toys, electronic devices, games, and bubbles, these techniques were tailored specifically to that child by a professional whom concentrated their entire attention on the task of providing distraction and easing the distress of the child. All children received customary clinical management of their injuries depending on burn size and depth. Wounds were cleansed with an antiseptic solution, blisters debrided and an antibacterial dressing applied; which was for the majority of cases, Acticoat 7TM (Smith and Nephew, Hull, England).
During the procedure an independent trained assessor recorded pain and anxiety scores of the child at two minutely intervals using the Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS) [15] and the Children’s Fear Scale [16] (Appendix 2). The use of unplanned analgesia or sedation during the procedure, as assessed and prescribed by the Burns Anaesthetic Fellow (e.g. nitrous oxide [maximum 70%] or intranasal fentanyl [1.5 mg/kg, 5 minutely until effect]), was recorded. Variables such as the length of the procedure, the presence of a healed burn on initial presentation, complex
Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
JBUR-4658; No. of Pages 11
4
burns xxx (2015) xxx–xxx
procedures (e.g. exercises, splinting or Laser Doppler Imaging), or highly anxious parents were noted. Post-procedure, children, parents/caregivers and nursing staff were asked to rate how they felt the procedure went, using combinations of the Wong Baker Faces Scale [17], a Visual Analogue Scale and by rating pain and anxiety from 0 to 10, where zero equals no pain or anxiety and ten equalling the worst pain or anxiety experienced (Appendix 3). All children subsequently received standard clinical care of their burns, which may have included skin grafting. Time to complete re-epithelisation (as clinically determined), wound infections (moderate - heavy colonisation on semi-quantitative wound swab or clinical evidence of infection) and the utilisation for skin grafting were subsequently recorded.
3.
Results
3.1.
Subject characteristics
The aim of this study was to determine how effective CLT (including pre- and intra-procedural support) was at reducing pain and anxiety in children throughout their initial treatment, as assessed by an independent trained assessor, using the CHEOPS [15] and Children’s Fear Scale [16]. Scaled average scores for both pain and anxiety were calculated and their sum used as the primary outcome measure.
There were 100 subjects recruited to the study, with 50 allocated to each treatment group. There were no statistically significant differences between either group. The median age in the CLT group was 2.3 years versus 2.2 years in the standard treatment group (Fig. 2). Mechanisms of injury were similar in both groups, with both scald and contact burns highly prevalent. The majority of injuries in both groups were to hands. The median percentage total body surface area (TBSA) was small in both groups (CLT 0.8% TBSA, and standard care 0.5% TBSA). The majority of injuries were partial thickness dermal burns, with very few full thickness injuries. All children received analgesia prior to their procedure, although the majority (CLT 78%; standard care 68%) received both analgesia and an anxiolytic. The majority of children in both groups (CLT 88%; standard care 90%) had previously visited a hospital, however only 56% in the CLT group and 64% in the standard care group had a prior procedure in hospital. One child in each group had previously worked with a CLTP (Table 1).
2.8.
3.2.
2.7.
Primary outcome
Secondary outcomes
Secondary outcomes included the use of any sedation or pain relief during the procedure: staff, parent and child rated pain and anxiety scores recorded immediately after the procedure and rating of the effectiveness of the therapy in the CLT group. Assessment of the number of days to complete wound reepithelialisation, the need for skin grafting and the development of infection was also undertaken.
2.9.
Statistical analysis
As continuous outcomes had skewed distributions, treatment groups were compared using the Wilcoxin rank sum test. Categorical outcomes were compared between groups using a chi-square test. A p-value of 0.05 was considered statistically significant.
Pre-procedural questionnaire
Prior to the procedure, parents/caregivers were asked to complete a questionnaire relating to their expectations of pain and anxiety experienced by their child during the procedure. Similar results were noted in both groups. Their own levels of anxiety was rated by parent/caregivers and noted as relatively high in both groups. Parents were also asked to rate their child’s current pain and anxiety levels (0–10) prior to the procedure. These were also very similar in both groups (Table 2).
3.3.
Procedural variables
There were multiple variables associated with each dressing change. The median length of the procedure was 16 min in both groups. Fewer children in the CLT received additional
Fig. 2 – Children’s ages. Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
JBUR-4658; No. of Pages 11
5
burns xxx (2015) xxx–xxx
Table 1 – Subject characteristics.
Median age (years) % Male Mechanism
Location of injury (majority)
Scald Contact Friction Flame Electrical Hand
Head/neck Upper limb (excl. hand) Lower limb Torso Median % TBSA Depth of injury
Dermal Full thickness Mixed Analgesia + Premedication anxiolytic Analgesia only Previous hospital visit First procedure in hospital Previous involvement with a Child Life Therapist
Table 3 – Procedure variables. Child Life Therapy (n = 50)
Standard care (n = 50)
2.3 (IQR 1.5–4.5) 25 (50%) 21 (42%) 21 (42%) 5 (10%) 2 (4%) 0 21 (42%)
2.2 (IQR 1.6–3.9) 27 (54%) 29 (58%) 16 (32%) 4 (8%) 1 (2%) 1 (2%) 15 (30%)
7 (14%) 7 (14%) 6 (12%) 9 (18%) 0.8% (IQR 0.5–2.0) 44 (88%) 0% 6 (12%) 39 (78%) 11 44 22 1
(22%) (88%) (44%) (2%)
Standard care (n = 50)
16 (IQR 10–26)
16 (IQR 12–22)
6 (12%)
9 (18%)
7 (IQR 6–8)
6 (IQR 5–7)
8 (16%) 4 (8%)
8 (16%) 6 (12%)
16 (32%)
21 (42%)
9 (18%) 13 (26%) 9 (18%) 4 (8%) 0.5% (IQR 0.5–2.0) 47 (94%) 1 (2%) 2 (4%) 34 (68%) 16 45 18 1
(32%) (90%) (36%) (2%)
analgesic medications, including nitrous oxide or intranasal fentanyl than the standard care group, with 6 subjects in the CLT group and 9 in the standard care group receiving additional medications. The median number of persons in the procedure room during the dressing was similar (7 in the CLT group and 6 in the standard care group). Highly anxious parents/caregivers were noted in 8 cases in both groups. 4 children were healed at their initial dressing change in the CLT group, versus 6 in the standard care group. Complex or lengthy procedures occurred in 16 cases in the CLT group and 21 in the standard care group (Table 3).
3.4.
Median length of procedure (min) Number of children who received extra medications Median number of people in procedure room Highly anxious parent Healed burn at initial dressing change Complex or lengthy procedure
Child Life Therapy (n = 50)
Intra-procedure pain and anxiety scores
Defined as our primary outcome, independently observed and rated, combined and scaled pain and anxiety scores were statistically better in the CLT group (CLT 1.7 versus standard care 2.9; p = 0.03). The median CHEOPS [15] pain score observed was significantly less in the CLT group ( p = 0.02), however there was no significant difference in fear scores ( p = 0.3).
Median CHEOPS [15] and Children’s Fear Scale [16] scores were the same in both groups at the beginning and the end of each procedure (Table 4).
3.5.
Post-procedural assessment
Post-procedure nursing staff, children and parents/caregivers were asked to complete questionnaires regarding pain and anxiety. There was limited child completion if questionnaires, likely due to the effects of sedation, analgesia or distress, such that we were unable to report their results. Nursing staff reported median scores (0–10) of 2.0 for both pain and anxiety experienced by children during the procedure in both groups, however rated the median effectiveness of CLT (0–10), in those children who received it, 9.0 (0–10, Table 5). The median parent/caregiver anxiety (0–10) experienced during the procedure was higher in the CLT group (CLT 5.0 versus standard care 3.5). In contrast parents/caregivers rated their child’s pain and anxiety, lower in the CLT group (CLT pain 2.0 versus standard care pain 3.0; CLT anxiety 3.0 versus standard care anxiety 4.3). Like the nursing staff, parents/ caregivers rated the effectiveness of CLT as 9.0 (0–10, Table 6).
3.6.
Wound outcomes
There was no significant difference between the rate of wound infections ( p = 0.5), skin grafting ( p = 0.3), or days to complete epithelisation ( p = 1) between either group (Table 7).
4.
Discussion
The role of a CLTP has become instrumental in the paediatric burns multidisciplinary team [18]. It has been well established
Table 2 – Results of pre-procedure parent/caregiver questionnaire. Child Life Therapy (n = 50) Parent/caregiver Parent/caregiver Parent/caregiver Parent/caregiver
expectation of child’s pain during dressing (median) (0–10) anxiety prior to procedure (median) (0–10) rated child pain prior to procedure (median) (0–10) rated child anxiety prior to procedure median (0–10)
7.0 7.0 3.5 2.0
(IQR (IQR (IQR (IQR
5.0–8.0) 5.0–8.0) 0.0–4.0) 1.0–5.0)
Standard care (n = 50) 6.3 6.0 3.0 2.0
(IQR (IQR (IQR (IQR
5.0–8.0) 4.0–8.0) 0.0–5.0) 0.0–5.0)
Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
JBUR-4658; No. of Pages 11
6
burns xxx (2015) xxx–xxx
Table 4 – Pain and anxiety scores.
Average, combined and scaled fear and pain scores 0–20 (median) Average CHEOPS pain score 4–13 (median) CHEOPS score at start of procedure 4–13 (median) CHEOPS score at end of procedure 4–13 (median) Average fear score 1–5 (median) Fear score at start of procedure 1–5 (median) Fear score at end of procedure 1–5
Child Life Therapy (n = 50)
Standard care (n = 50)
1.7 (IQR 0.6–4.5)
2.9 (IQR 1.9–5.7)
0.1–1.8
0.03
5.3 5.0 5.0 1.2 1.0 1.0
6.0 5.0 5.0 1.3 1.0 1.0
0.1–1.2
0.02
(IQR (IQR (IQR (IQR (IQR (IQR
4.5–6.7) 4.0–6.0) 4.0–6.0) 1.0–1.6) 1.0–1.0) 1.0–1.0)
(IQR (IQR (IQR (IQR (IQR (IQR
5.4–7.6) 5.0–6.0) 4.0–6.0) 1.0–1.7) 1.0–1.0) 1.0–1.0)
95% confidence limits
0–0.2
p-value
0.3
Table 5 – Staff assessment. Child Life Therapy (n = 50) Child anxiety prior to procedure 0–10 (median) Child anxiety during procedure 0–10 (median) Child pain prior to procedure 0–10 (median) Child pain during procedure 0–10 Effectiveness of Child Life Therapy 0–10 (median)
2.0 2.0 1.0 2.0 9.0
(IQR (IQR (IQR (IQR (IQR
Standard care (n = 50)
0.0–4.0) 0.0–5.0) 0.0–2.0) 0.0–4.0) 8.0–10.0)
1.5 (IQR 0.0–3.0) 2.0 (IQR 1.0–7.0) 0.5 (IQR 0.0–1.0) 2.0 (IQR 0.0–5.0) Not applicable
Table 6 – Parent/caregiver assessment. Child Life Therapy (n = 50) Parent anxiety during the procedure 0–10 (median) Child’s anxiety during the procedure 0–10 (median) Child’s pain during procedure 0–10 (median) Effectiveness of Child Life Therapy 0–10 (median)
5.0 3.0 2.0 9.0
(IQR (IQR (IQR (IQR
Standard care (n = 50)
1.0–7.0) 1.0–6.0) 0.0–4.0) 9.0–10.0)
3.5 (IQR 2.0–7.5) 4.3 (IQR 1.0–8.0) 3.0 (IQR 1.0–7.0) Not applicable
Table 7 – Wound outcomes.
Wound infection Received skin grafting Days to healing (median)
Child Life Therapy (n = 50)
Standard care (n = 50)
3 (6%) 9 (18%) 11.5 (IQR 8.0–18.0)
5 (10%) 13 (26%) 12.0 (IQR 7.0–21.0)
that the use of distraction during medical procedures significantly reduces pain and anxiety experienced by children [9,19]. There have been multiple studies confirming the effectiveness of specific CLT devices and techniques in burns; for example virtual reality, music therapy, or use of the DittoTM device (Diversional Therapy Technologies, Brisbane, Australia) [7,10,11,20–23]. In our Burn Unit, not only have we found that specific techniques and devices appear beneficial, but the role of a CLTP has anecdotally also had a significant impact on the reduction of pain and anxiety experienced by children with acute burns. Unlike static techniques, electronic devices, or distraction provided by parents, who are often as distressed as the child, CLTP can easily adapt to fluctuating changes in the environment, provide age and procedure appropriate distraction and provide pre-procedural preparation adapted for the child, their family and their past experiences [12]. Using techniques attributed to psychological therapies such as Cognitive Behavioural Therapy [8,24], CLTP can assist in thought restructuring: for example via emphasising whilst pain ‘‘hurts’’ it does not ‘‘harm’’ [5]. Psychological therapies described in the literature and used by CLTP may include those of cognitive, preparatory, behavioural or distraction techniques [6,25].
95% confidence limits
p-value
3.0–3.0
0.5 0.3 1
Burns and their treatment can be extremely painful. Children may become especially distressed and anxious due to their immaturity, prior experiences and poor coping strategies [1,2,26–28]. Procedural pain associated with acute burns, such as dressing changes, in contrast to other types of burn related pain, has been shown to be significant and perhaps exacerbated by anticipation and fear of the unknown [3,5,6,29]. Poorly managed pain and anxiety during acute burn management has been shown to increase the incidence of subsequent psychological disorders, including post-traumatic stress disorder [2,7,26,29–32]. In addition to emotional distress and potential psychological harm, the pathophysiological response to pain and anxiety, leading to release of stress hormones such as cortisol [33], could also potentially impact wound healing [34]. Unfortunately, whilst burn pain and anxiety have been shown to have many adverse effects, they continue to often be poorly managed [3,35]. Any method which reduces pain and anxiety in acutely burnt children should therefore be considered in standard practice. Pain associated with burns is thought to derive from direct noxious chemical and mechanical stimulation, and damage of peripheral nociceptors with proceeding central sensitisation [6]. Cytokines, such as interleukin-6, released in response to burns can also be significant mediators of pain [36]. Not only
Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
JBUR-4658; No. of Pages 11 burns xxx (2015) xxx–xxx
does pain have significant psychological impacts upon burn injured children [2,7,32], it may also be associated with significant pathophysiological adverse outcomes, contribute to burn hypermetabolism and if poorly treated has been hypothesised to lead to more morbidity and mortality associated with burns [37]. One aspect of Melzack and Wall’s Gate Control Theory of pain suggests that as the mind has the ability to cope with limited amounts of information at any one time [38], therefore distraction provided by CLT would seem likely to be highly effective in reducing the experience of pain [10]. A child focused on pain may suffer an increased pain experience, whereas a child distracted, may experience reduced levels of pain [39]. Distraction provided by nursing and medical staff is often ad hoc, intermittent and may refocus the child on the painful procedure being undertaken due to staff members returning to the prescribed task. CLTPs, however, would be able to focus their complete attention on the child, providing uninterrupted distraction throughout the procedure [39], and would therefore be capable of blunting the pain experience [38]. Our results remain consistent with this theory, as a significant reduction was found in those children exposed to CLT, as rated by an independent observer. Depending on %TBSA effected, acute burns cause significant stress responses via neurohumoural dysregulation, massive sympathetic outflow and the pathological release of cytokines and stress hormones such as cortisol [1,33]. It has been hypothesised that stress related dysfunction of the hypothalamic–pituitary axis leads to significant influences on brain development and may have a lifelong impact on anxiety and coping strategies [1]. It has been well established that poorly managed pain and anxiety during acute burn procedures can lead to post-traumatic stress disorder, development of antisocial behaviour and sleep disturbance [3,30]. Our results indicate that the use of a CLT did not alter the level of anxiety or stress experienced by children in our study. The study was limited by the subjective measures we have employed and salivary cortisol levels may have been a beneficial objective measure of stress [11,40]. Wound healing, rates of infection and the need for skin grafting were similar in both groups, however, which supports our finding of similar levels of stress and anxiety experienced by the children in our study. Parental presence can alter pain and anxiety experiences dramatically. Studies have shown that parental presence reduces the amount of distress experienced by children during painful procedures [28,41]. Parents may, however, worsen a child’s distress if they express high levels of anxiety and agitation themselves [42]. One of the roles of a CLT has been to work with the whole family, training parents in techniques to manage their own anxiety and to assist them in encouraging coping strategies for their child [41]. Despite this, we found that levels of observed parental anxiety were similar in both groups, and interestingly parent rated anxiety levels were higher in the CLT group. An explanation for this finding could be that majority of parents are highly anxious during their child’s initial presentation to our Burn Unit. This anxiety is often exacerbated by feelings of guilt. It is likely, however, that over multiple visits a positive relationship would develop between the therapist, the child and their family and that the
7
benefits of CLT would negate the psychological and physiological harm associated with stress and pain of burns. Several parents commented during subsequent visits to our Burn Unit that the relationship that their child developed with the CLTP over several visits had a positive effect on their child’s level of pain and anxiety. Unfortunately, our study was limited to the initial dressing experience in our Burn Unit as there would have been multiple confounders associated with healing burns upon subsequent visits. Therefore the potential benefits of continuity of care were not validated. All children with burns remain unique and differ in their response to CLT [43]. Pain and anxiety continue to be subjective and individual experiences that remain difficult to analyse and quantify, especially in children [44,45]. Whilst advances in pain scales may have assisted in the analysis of pain in children [46,47], toddlers, who make the large majority of children whom we treat in our Burn Unit, are usually non- or minimally verbal. For some children pain or distress may resemble bad behaviour or emotional lability. Children are often not able to express their pain or distress in a meaningful way and manifestations of pain and anxiety may be difficult to interpret and quantify. Therefore despite the many assessment tools available to assess pain and anxiety in children, any study which analyses such outcomes in children remains fraught with potential difficulty.
5.
Conclusion
This randomised controlled trial found that the presence of a CLTP during initial burn dressing changes in our Burn Unit reduced the amount of pain experienced by children. Whilst our study did not find a reduction in children’s fear scores during initial dressing changes, it is likely that over subsequent visits a rapport with the CLTP would develop and distress reduce. Better management of childhood pain and anxiety is likely to reduce the potential risk of devastating and life long consequences of poorly managed pain and anxiety. It is likely that the ability of CLTPs to adapt to environmental changes associated with burns dressings, provide patient and family tailored distraction, and their ability to build relationships with the child and their family to provide continuity of care provides a higher quality of pain and anxiety management than the intermittent use of ad hoc toys and games by non-CLTPs.
Author’s contributions EJH, RDC, CP, JGH and AJAH designed the study; EJH, CP and JM conducted the literature review; EJH and AJAH were involved in writing the manuscript; and JGH and AJAH critically appraised the draft manuscript. All authors approved the final manuscript.
Conflicts of interest The authors declare no conflicts of interest. A paid independent observer was employed to undertake data collection.
Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
JBUR-4658; No. of Pages 11
8
burns xxx (2015) xxx–xxx
Acknowledgements We would like to acknowledge the contribution of Biostatistician Elizabeth Barnes from the University of Sydney. We
would also like to acknowledge the hard work of Karen Weir for her significant contribution to this study. Finally, we would like to thank the children and their families involved in this study, their instrumental assistance and commitment was greatly appreciated.
Appendix 1. Pre-procedural pain and anxiety questionnaire
Parent/caregiver: How painful do you expect the procedure to be? How anxious are you BEFORE the procedure? Your child’s anxiety level BEFORE the procedure Your child’s pain level BEFORE the procedure
0–10 (10 = maximal) 0–10 0–10 0–10
Appendix 2. Intra-procedural tools used by independent observer to rate pain and anxiety 1. Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS) [15]
Parameter
Finding
Explanation
Points
Cry
No cry Moaning Crying Screaming Smiling Composed Grimace Positive None Complaints other than pain Pain complaints Both pain and non-pain complaints Neutral Shifting Tense Shivering Upright Restrained Not touching Reach Touch Grab Restrained Neutral Squirming Drawn up tensed Standing Restrained
Child is not crying Moaning or silent cry Gentle or whimpering cry Full lunged cry, sobbing Positive facial expression Neutral facial expression Negative facial expression Talks without complaint Not talking e.g. ‘‘I want Mummy, I am thirsty’’
1 2 2 3 0 1 2 0 1 1 2 2 1 2 2 2 2 2 1 2 2 2 2 1 2 2 2 2
Facial
Child Verbal
Torso
Touch
Legs
Body is at rest, torso is inactive Body is arched or rigid Shuddering or shaking involuntarily Vertical Not touching wound Reaching for but not touching wound Gently touching wound Grabbing vigorously at wound Child’s arms are restrained Legs are relaxed Uneasy, restless movements, striking out with foot Legs tensed and pulled up near body
Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
JBUR-4658; No. of Pages 11
9
burns xxx (2015) xxx–xxx
2. Children’s Fear Scale [16]
Appendix 3. Post-procedural measures of pain and anxiety
Parent/caregiver: How anxious were you DURING the procedure? Your child’s anxiety level DURING the procedure Your child’s pain level DURING the procedure If Child Life Therapist was present: How effective do you think Child Life Therapy was in reducing your child’s PAIN and ANXIETY? (0 – no effect ! 10 – very effective)
0–10 (10 = maximal) 0–10 0–10
Child 5–10 years:
1. Wong Baker Faces Pain Scale [17]
2. Children’s Fear Scale [16] Young person 10 years:
1. Visual Analogue Pain scale 0–10 (10 = maximal pain) 2. Children’s Fear Scale [16]
Nursing staff: The child’s anxiety level BEFORE the procedure The child’s anxiety level DURING the procedure The child’s pain level BEFORE the procedure The child’s pain level DURING the procedure If Child Life Therapist was present: How effective do you think Child Life Therapy was in reducing the child’s PAIN and ANXIETY? (0 – no effect ! 10 – very effective)
0–10 (10 = maximal) 0–10 0–10 0–10
Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
JBUR-4658; No. of Pages 11
10
burns xxx (2015) xxx–xxx
references
[1] Stoddard FJ, Sheridan RL, Saxe GN, King BS, King BH, Chedekel DS, et al. Treatment of pain in acutely burned children. J Burn Care Rehabil 2002;23:135–56. [2] Gandhi M, Thomson C, Lord D, Enoch S. Management of pain in children with burns. Int J Pediatr 2010;2010. [3] Richardson P, Mustard L. The management of pain in the burns unit. Burns 2009;35:921–36. [4] Winskill R, Andrews D. Minimizing the ‘ouch’ – a strategy to minimize pain, fear and anxiety in children presenting to the emergency department. Australas Emerg Nurs J 2008;11:184–8. [5] Patterson DR, Hofland HW, Espey K, Sharar S. Nursing Committee of the International Society for Burn. I. Pain management. Burns 2004;30:A10–5. [6] Abdi S, Zhou Y. Management of pain after burn injury. Curr Opin Anaesthesiol 2002;15:563–7. [7] Hanson MD, Gauld M, Wathen CN, Macmillan HL. Nonpharmacological interventions for acute wound care distress in pediatric patients with burn injury: a systematic review. J Burn Care Res 2008;29:730–41. [8] Anderson Khan K, Weisman S. Nonpharmacologic pain management strategies in the pediatric emergency department. Clin Pediatr Emerg Med 2007;8:240–7. [9] Koller D, Goldman RD. Distraction techniques for children undergoing procedures: a critical review of pediatric research. J Pediatr Nurs 2012;27:652–81. [10] Tan X, Yowler CJ, Super DM, Fratianne RB. The efficacy of music therapy protocols for decreasing pain, anxiety, and muscle tension levels during burn dressing changes: a prospective randomized crossover trial. J Burn Care Res 2010;31:590–7. [11] Brown NJ, Kimble RM, Rodger S, Ware RS, Cuttle L. Play and heal: randomized controlled trial of Ditto intervention efficacy on improving re-epithelialization in pediatric burns. Burns 2014;40:204–13. [12] Committee On Hospital Care and Child Life Council. Child life services. Pediatrics 2014;133:e1471–8. [13] Tyson ME, Bohl DD, Blickman JG. A randomized controlled trial: child life services in pediatric imaging. Pediatr Radiol 2014;44:1426–32. [14] 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. J Pediatr Oncol Nurs 2007;24:8–19. [15] McGrath P, Johnston G, Goodman JT. CHEOPS: a behavioral scale for rating postoperative pain in children. In: Fields H, Dubner R, Cervero F, editors. Proceeding of the 4th world congress on pain: advances in pain research and therapy. New York, USA: Raven Press; 1985. p. 395–401. [16] McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children’s fear during procedural pain: preliminary investigation of the children’s fear scale. Health Psychol 2011;30:780–8. [17] Wong DL, Baker CM. Smiling faces as anchor for pain intensity scales. Pain 2001;89:295–300. [18] D’Cruz R, Martin HC, Holland AJ. Medical management of paediatric burn injuries: best practice part 2. J Paediatr Child Health 2013. [19] Kleiber C, Harper DC. Effects of distraction on children’s pain and distress during medical procedures: a metaanalysis. Nurs Res 1999;48:44–9. [20] Jeffs D, Dorman D, Brown S, Files A, Graves T, Kirk E, et al. Effect of virtual reality on adolescent pain during burn wound care. J Burn Care Res 2014;35:395–408.
[21] Schmitt YS, Hoffman HG, Blough DK, Patterson DR, Jensen MP, Soltani M, et al. A randomized, controlled trial of immersive virtual reality analgesia, during physical therapy for pediatric burns. Burns 2011;37:61–8. [22] Das DA, Grimmer KA, Sparnon AL, McRae SE, Thomas BH. The efficacy of playing a virtual reality game in modulating pain for children with acute burn injuries: a randomized controlled trial [ISRCTN87413556]. BMC Pediatr 2005;5:1. [23] Miller K, Rodger S, Bucolo S, Greer R, Kimble RM. Multimodal distraction, using technology to combat pain in young children with burn injuries. Burns 2010;36:647–58. [24] American Academy of Pediatrics Child Life Council and Committee on Hospital Care, Wilson JM. Child life services. Pediatrics 2006;118:1757–63. [25] Patterson DR. Practical applications of psychological techniques in controlling burn pain. J Burn Care Rehabil 1992;13:13–8. [26] Stoddard FJ. Coping with pain: a developmental approach to treatment of burned children. Am J Psychiatry 1982;139:736–40. [27] Blount R. The influence of environmental factors and coping style on children’s coping and distress. Clin Psychol Rev 1991;11:93–116. [28] Dise-Lewis JE. A developmental perspective on psychological principles of burn care. J Burn Care Rehabil 2001;22:255–60. [29] Elliott CH, Olson RA. The management of children’s distress in response to painful medical treatment for burn injuries. Behav Res Ther 1983;21:675–83. [30] Taal LA, Faber AW. Burn injuries, pain and distress: exploring the role of stress symptomatology. Burns 1997;23:288–90. [31] Stoddard FJ, Norman DK, Murphy JM, Beardslee WR. Psychiatric outcome of burned children and adolescents. J Am Acad Child Adolesc Psychiatry 1989;28:589–95. [32] Browne AL, Andrews R, Schug SA, Wood F. Persistent pain outcomes and patient satisfaction with pain management after burn injury. Clin J Pain 2011;27:136–45. [33] Brown NJ, Kimble RM, Rodger S, Ware RS, McWhinney BC, Ungerer JP, et al. Biological markers of stress in pediatric acute burn injury. Burns 2014;40:887–95. [34] Brown NJ, Kimble RM, Gramotnev G, Rodger S, Cuttle L. Predictors of re-epithelialization in pediatric burn. Burns 2014;40:751–8. [35] Summer GJ, Puntillo KA, Miaskowski C, Green PG, Levine JD. Burn injury pain: the continuing challenge. J Pain 2007;8:533–48. [36] Summer GJ, Romero-Sandoval EA, Bogen O, Dina OA, Khasar SG, Levine JD. Proinflammatory cytokines mediating burn-injury pain. Pain 2008;135:98–107. [37] Latarjet J, Choinere M. Pain in burn patients. Burns 1995;21:344–8. [38] Melzack R, Wall PD. Pain mechanisms: a new theory. Science 1965;150:971–9. [39] Beales JG. Factors influencing the expectation of pain among patients in a children’s burns unit. Burns Incl Therm Inj 1983;9:187–92. [40] Sudhaus S, Held S, Schoofs D, Bultmann J, Duck I, Wolf OT, et al. Associations between fear-avoidance and endurance responses to pain and salivary cortisol in the context of experimental pain induction. Psychoneuroendocrinology 2014;52C:195–9. [41] Bachanas PJ, Blount RL. The behavioral approachavoidance and distress scale: an investigation of reliability and validity during painful medical procedures. J Pediatr Psychol 1996;21:671–81. [42] Penner LA, Cline RJ, Albrecht TL, Harper FW, Peterson AM, Taub JM, et al. Parents’ empathic responses and pain and distress in pediatric patients. Basic Appl Soc Psychol 2008;30:102–13.
Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017
JBUR-4658; No. of Pages 11 burns xxx (2015) xxx–xxx
[43] Nilsson S, Renning AC. Pain management during wound dressing in children. Nurs Stand 2012;26:50–5. [44] von Baeyer CL. Children’s self-reports of pain intensity: scale selection, limitations and interpretation. Pain Res Manag 2006;11:157–62. [45] Stanford EA, Chambers CT, Craig KD. The role of developmental factors in predicting young children’s use of a self-report scale for pain. Pain 2006;120:16–23.
11
[46] Ratcliff SL, Brown A, Rosenberg L, Rosenberg M, Robert RS, Cuervo LJ, et al. The effectiveness of a pain and anxiety protocol to treat the acute pediatric burn patient. Burns 2006;32:554–62. [47] Kelly AM, Powell CV, Williams A. Parent visual analogue scale ratings of children’s pain do not reliably reflect pain reported by child. Pediatr Emerg Care 2002;18: 159–62.
Please cite this article in press as: Hyland EJ, et al. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial. Burns (2015), http://dx.doi.org/10.1016/j.burns.2015.05.017