Virtual reality for acute pain reduction in adolescentsundergoing burn wound care: A prospective randomizedcontrolled trial

Belinda Kipping a,b,c,d,*, Sylvia Rodger b, Kate Miller a,b,c,d, Roy M. Kimble a,c

aThe Centre for Children’s Burns and Trauma Research, Queensland Children’s Medical Research Institute, The Department of Paediatrics and

Child Health, The University of Queensland, Royal Children’s Hospital, Brisbane, AustraliabThe University of Queensland, School of Health and Rehabilitation, Division of Occupational Therapy, Brisbane, AustraliacThe University of Queensland, School of Medicine, Department of Paediatrics and Child Health, Brisbane, AustraliadDepartment of Occupational Therapy and Music Therapy, Royal Children’s Hospital, Brisbane, Australia

b u r n s 3 8 ( 2 0 1 2 ) 6 5 0 – 6 5 7

a r t i c l e i n f o

Article history:

Accepted 17 November 2011

Keywords:

Pain

Distraction

Virtual reality

Adolescent

Pediatric

Burns

a b s t r a c t

Background: Effective pain management remains a challenge for adolescents during con-

scious burn wound care procedures. Virtual reality (VR) shows promise as a non-pharma-

cological adjunct in reducing pain.

Aims: This study assessed off-the-shelf VR for (1) its effect on reducing acute pain intensity

during adolescent burn wound care, and (2) its clinical utility in a busy hospital setting.

Methods: Forty-one adolescents (11–17 years) participated in this prospective randomized

controlled trial. Acute pain outcomes including adolescent self-report, nursing staff behav-

ioral observation, caregiver observation and physiological measures were collected. Length

of procedure times and adolescent reactions were also recorded to inform clinical utility.

Results: Nursing staff reported a statistically significant reduction in pain scores during

dressing removal, and significantly less rescue doses of Entonox given to those receiving VR,

compared to those receiving standard distraction. For all other pain outcomes and length of

treatment, there was a trend for lower pain scores and treatment times for those receiving

VR, but these differences were not statistically significant.

Conclusion: Despite only minimal pain reduction achieved using off-the-shelf VR, other

results from this trial and previous research on younger children with burns suggest a

customized, adolescent and hospital friendly device may be more effective in pain reduction.

# 2012 Published by Elsevier Ltd and ISBI.

Available online at www.sciencedirect.com

journal homepage: www.elsevier.com/locate/burns

1. Introduction

The pain experienced during burn wound care is clinically well

known, yet poorly researched in adolescents. Due to the

nature of burns, repeated painful wound care dressing

changes are required regularly to facilitate wound healing.

Effective pain management associated with these procedures

* Corresponding author at: Centre for Children’s Burns and Trauma ReFoundation Building, Royal Children’s Hospital, Brisbane, QLD 4029, A

E-mail address: belinda.kipping@uqconnect.edu.au (B. Kipping).

0305-4179/$36.00 # 2012 Published by Elsevier Ltd and ISBI.doi:10.1016/j.burns.2011.11.010

remains a challenge for burn healthcare professionals around

the world. Adjunctive non-pharmacological techniques are

often combined with routine pharmacological protocols. Even

with this multimodal approach, current pain management

practices are still considered inadequate [1–4].

The pain and trauma associated with medical procedures

such as burn wound care does not always end with the

procedure. There is increasing recognition of the short and

search, Queensland Children’s Medical Research Institute, Level 4,ustralia. Tel.: +61 7 3365 5338; fax: +61 7 3365 5455.

Table 1 – VAS descriptors used in this trial.

Pain 0 = no pain, 10 = pain as bad as it

could possibly be

Presence 0 = not at all, 10 = totally went into

the game world

Nausea 0 = no sick tummy, 10 = sick tum-

my as bad as it could possibly be

b u r n s 3 8 ( 2 0 1 2 ) 6 5 0 – 6 5 7 651

long term consequences that can result from these experi-

ences, particularly for those who have not reached adulthood

[1,5–7]. Reported examples include increased sensitivity to

pain and poor psychological well-being and functioning [5–7].

The range of adjunctive non-pharmacological interven-

tions available for use in pediatric and adolescent acute pain

management is wide and varied. Psychological and distrac-

tion-based (also referred to as attention-based [8]) approaches

such as, hypnosis, parental participation, music, movies and

virtual reality (VR) related technologies have featured in the

literature [9–14].

VR technology is a promising adjunctive pain management

tool for adolescents, as demonstrated by some successful

trials with children and adults [14–16]. Evidence in the

adolescent age range and burn wound care context is limited

by small sample sizes [13,15]. Its mechanism of action is

attributed to the gate control theory of pain [17]. In

acknowledgement of budgetary limits commonly associated

with healthcare, this trial chose a VR system that was

accessible and affordable (off-the-shelf VR), over more

expensive and customized hardware and software options.

The following research questions were designed to build on

the current lack of evidence. For adolescents (11–17 years)

undergoing burn wound care, does off-the-shelf VR reduce

pain levels more than standard distraction? In terms of clinical

utility in an acute hospital environment, does it reduce length

of wound care procedures and with no adverse reactions? It

was hypothesized that the adolescents who received off-the-

shelf VR during their wound care procedure would experience

less pain intensity and reduced treatment times than those

who received standard distraction.

2. Methods

This study was a prospective randomized controlled trial (RCT)

with a parallel group design. Ethics approval for this project

was obtained from the Royal Children’s Hospital (RCH), Royal

Brisbane and Women’s Hospital (RBWH), and The University

of Queensland, Human Research Ethics Committees.

2.1. Participants

Between November 2008 to February 2010, adolescents (11–17

years) were recruited across two neighboring tertiary hospital

sites; 10–14 years from the Stuart Pegg Paediatric Burn Centre

(SPPBC) RCH and 15–17 years from Stuart Pegg Adult Burn Unit

(SPABU) RBWH, Brisbane, Australia. Inclusion criteria were; (1)

adolescents 11 to <18 years, (2) attendance at SPABU or SPPBC,

(3) first conscious change of dressing, and (4) burn wound Total

Body Surface Area (TBSA) greater than 1%. Exclusion criteria

were: (1) cognitive impairment preventing the use of outcome

measures, (2) visual/hearing impairment unable to be cor-

rected, (3) wound location impacting the ability to use the off-

the-shelf VR device, (4) non-English speaking, and (5) child

safety and protection issues. Sample size calculations indicat-

ed at least 16 participants were required in each group for

between group analysis (with a power 0.8, Type I error rate

0.05, and a 2.0 point reduction on a 10.0 point Visual Analogue

Scale, VAS).

2.2. Clinical outcomes

Pain intensity measures included the VAS [18] for adolescent

self-report and caregiver observations and Faces, Legs,

Activity, Cry, Consolability (FLACC) Scale [19] for nursing staff

observations as well as physiological parameters of heart rate

and oxygen saturations. These were chosen based on; (1) the

evidence that supports their use within this age range and

clinical context, (2) their ease of use and nursing staff

familiarity, and (3) PedIMMPACT recommendations [4,14,20].

2.2.1. Visual analogue scale (VAS) [18]The VAS was a 10 cm horizontal line with each end anchored

by word descriptors (see Table 1 for VAS word descriptors used

in this trial). Test–retest reliability for the VAS in previous

studies showed strong correlations (r = .99) in adolescents

during acute medical procedures [21]. Inter-rater reliability

correlated highly with pain measurement when completed by

nursing staff post-operatively [21,22]. Recent researchers

using the VAS to measure pain outcomes with VR related

technology with younger children have also used the VAS with

caregivers [14,23]. In the current study, the VAS was used for

adolescent self-report and caregiver observation.

2.2.2. Faces, legs, activity, cry, consolability (FLACC) scale [19]The FLACC scale is another well-established pain measure-

ment tool, with extensive reliability and validity data

[19,20,24]. Highly recommended in clinical trials, it is reported

to have excellent inter-rater reliability (r = 0.87) [25], as well as

good concurrent validity with the VAS [20]. The nursing staff

provided scores for each of the five measurement categories

(faces, legs, activity, cry and consolability) on a scale of 0–2

(using the word descriptions that best describe the behavior

for each category). A total pain score out of a maximum 10 was

provided by nurses at three time intervals.

2.2.3. Physiological measuresHeart rate and oxygen saturations were also recorded, using a

pulse oximeter machine, with a sensor placed on the

adolescent’s finger or toe. It is acknowledged that the use of

physiological measures is contentious due to reports of weak

to moderate correlations between physiological changes and

painful events [26], and the potential influence from other

variables such as fear, anxiety, and exertion [20,27]. Despite

this, objective physiological outcome measures such as these

are still recommended to ensure a comprehensive approach

when conducting clinical pain trials [4,20,28].

2.2.4. Adolescent reactionsAdolescent reactions were monitored during VR using VAS

[18]. These included self-report of ‘‘presence’’; defined as ‘‘the

subjective experience of being in one place or environment,

Fig. 1.1 – Picture of an adolescent using the off-the-shelf VR

system.

b u r n s 3 8 ( 2 0 1 2 ) 6 5 0 – 6 5 7652

even when one is physically situated in another’’ (p. 225) [29],

and self-report of nausea to monitor for any potential

simulator sickness that can sometimes be associated with

VR use [13,30].

2.3. Procedures

Written informed consent (and adolescent assent) was

obtained from caregivers prior to randomization. Random

sequence was computer generated (1:1, blocks of 20),

concealed in consecutively numbered sealed opaque envel-

opes, and opened by an independent staff member (adminis-

tration officer). Both groups received identical wound care

procedures and medication protocols, and participation was

for the first conscious change of dressing only.

Using a standard script, the primary investigator (PI) who

was present at each burn dressing recorded the clinical

outcome measures from adolescent (VAS), caregiver (VAS) and

nursing staff (FLACC) at three time points namely; (T1)

baseline (prior to randomization and procedure commence-

ment), retrospectively after dressing removal (T2) and dress-

ing application (T3). The PI also recorded pain physiological

measures at 2-min intervals, and the length of procedure (of

dressing removal and dressing application) in minutes. All

outcome measure responses were recorded by the participant,

his/her caregiver and nurse unobtrusively placing a mark on

the data collection sheet, to minimize the risk of bias of

overhearing responses from those involved.

2.4. Interventions

The VR group (VRG) received distraction via an off-the-shelf

VR system, which included a head mounted display (eMagin,

Z800 3DVisor with headtracking and 2 high contrast SVGA

resolution 800 � 600 16.7 million colours), joystick hand

control (LOGIK PC ATTACK 3), personal computer and off-

the-shelf, age appropriate software games (Chicken LittleTM

for the 11–13 years old, and an additional choice of Need for

SpeedTM for the 14–17 years old). The VRG accessed the off-

the-shelf VR system in their individual treatment room a few

minutes prior to the commencement of the procedure. See Fig.

1.1.

The standard distraction group (SDG) had access to TV,

stories, music, caregivers or no distraction in the treatment

room as was their choice and as per standard practice at SPPBC

and SPABU.

2.5. Statistical analysis

SPSS 18.00TM program was used for all statistical analyses.

Normality and baseline homogeneity between groups was

assessed to ensure similarity at baseline. Intention to treat

analysis was completed with all participants analyzed as

allocated, with omission of missing pain report data for the

one participant specific to the dressing application phase only

(representing only 2.4% of total sample). Differences between

groups were analyzed using independent samples t-tests for

pain intensity (VAS and FLACC change scores, heart rate mean

scores), length of dressing removal in minutes and nausea

change scores. Change scores (i.e. T2 minus T1) were used to

take into account baseline data for each group, where

applicable. Where the data were not normally distributed

(i.e. length of dressing and oxygen saturations) Mann–

Whitney U tests were performed. Frequency of adolescents

requiring rescue doses (medication prescribed after com-

mencement of the procedure) of Entonox and adverse

reactions were also compared using a Chi-square test.

Descriptive data on the level of presence are also illustrated

in the results section.

3. Results

3.1. Sample

The consort diagram (Fig. 2.1) illustrates a total of 132

adolescents were assessed for their eligibility, with 41

randomized and 91 excluded (69 not meeting inclusion

criteria, 6 declining to participate and 16 missed due to first

dressing change occurring out of work hours, or attendance

missed). All participants received their treatment as allocated,

however one participant withdrew from the trial (intervention

group) halfway through the dressing change, as the adolescent

reported not wanting to continue playing with VR. There were

no significant differences between groups at baseline for any

measures (age, TBSA, sex, depth of burn, mode, location of

care, admission status, and dressings used and medications

given) (see Table 2).

3.2. Pain intensity

Mean difference in pain scores (change scores) reported by

adolescents, caregivers and nursing staff for each group are

provided in Table 3. For adolescent self-report of pain, mean

pain scores were higher for the SDG compared to the VRG in

both dressing removal and application, however these

differences were not statistically significant (Fig. 3.1). Nursing

staff observations using FLACC revealed statistically signifi-

cant differences between VRG and SDG during dressing

removal, with less pain behaviors observed for the VRG.

Assessed for eligibility (n=132)

Excluded (n=91)Not meeting inclusion criteria (n=69)Declined to participate (n=6) Other reasons (n=16) Missed as not

told, attended out of work hours, orprimar y investigator away on leave

Analysed (n=20)Excluded from analysis (n=0 )

Lost to follow-up (n=0)

Discontinued intervention (participant refused,reporting did not want to keep using VR) (n=1)

Allocated to VRG (n=20)Received allocated intervention (n=20)Did not receive allocated intervention (n=0 )

Lost to follow-up (n=0)

Discontinued intervention (n=0)

Allocated to SDG (n=21)Received allocated intervention (n=21)Did not receive allocated intervention (n=0)

Analysed (n=21)Excluded from analysis (n=0 )

Allocation

Analysis

Follow-Up

Randomized (n=41)

Enrollment

Fig. 2.1 – CONSORT flow chart.

Table 2 – Baseline demographic characteristics.a

SDG (n = 21) VRG (n = 20) Total (n = 41) p-Value

Age, years 13.5 (1.8) 12.6 (1.3) 13.08 (1.6) p = 0.08

TBSA, % 4.7 (4.5) 5.1 (6.3) 4.9 (5.4) p = 0.93

Sex, male 15 (71.4%) 13 (65%) 28 (68.3%) p = 0.92

Depth p = 0.90

Superficial partial dermal thickness 9 (42.9%) 8 (40%) 17 (41.5%)

Deep dermal partial thickness 8 (38.1%) 7 (35%) 15 (36.6%)

Full thickness 4 (19%) 5 (25%) 9 (22%)

Mode p = 0.86

Scald 5 (23.8%) 7 (35%) 12 (29.3%)

Contact 2 (9.5%) 2 (10%) 4 (9.8%)

Flame 8 (38.1%) 7 35(%) 15 (36.6%)

Friction 6 (28.6%) 4 (20%) 10 (24.4%)

Location of care p = 0.37

SPPBC 17 (81%) 19 (95%) 36 (87.8%)

SPABU 4 (19%) 1 (5%) 5 (12%)

Admission Status p = 1.0

Inpatient 7 (33.3%) 6 (30%) 13 (31.7%)

Outpatient 14 (66.7%) 14 (70%) 28 (68.3%)

Dressings p = 1.0

ActicoatTM 18 (85.7%) 17 (85%) 35 (85.4%)

Petroleum-based 3 (14.3%) 3 (15%) 6 (14.6%)

Medication p = 0.57

Nil 1 (4.8%) 2 (10%) 3 (7.3%)

Opioid 18 (85.7%) 14 (70%) 32 (78%)

Opioid and other (i.e. paracetamol, Entonox) 2 (9.5%) 3 (15%) 5 (12.2%)

Paracetamol and Entonox 0 (0%) 1 (5%) 1 (2.4%)

a Data are means (SD) or numbers (%).

b u r n s 3 8 ( 2 0 1 2 ) 6 5 0 – 6 5 7 653

Table 3 – Mean change scores for pain intensity and nausea.a

SDG VRG p-Value

Adolescent VAS dressing removal 4.2 (3.2) 2.9 (2.3) p = 0.16

Adolescent VAS dressing application 3.8 (3.6) 2.33 (3.4) p = 0.40

Nursing staff FLACC dressing removal 4.7 (2.5) 2.9 (2.4) p = 0.02b

Nursing staff FLACC dressing application 3.0 (2.8) 1.9 (2.8) p = 0.23

Caregiver VAS dressing removal 3.8 (3.2) 3.5 (2.5) p = 0.71

Caregiver VAS dressing application 2.2 (4.0) 2.6 (3.5) p = 0.75

Nausea dressing removal �0.3 (1.5) �0.7 (1.1) p = 0.27

Nausea dressing application �0.5 (1.3) �0.3 (1.0) p = 0.65

a Data are means (SD).b Statistically significant.

2

6.2 5.3

1.6

4.6 3.9

0

2

4

6

8

10

Baseline DressingRemoval

DressingApplication

Mean painscore

Standard Deviation

Virtual Reality

Fig. 3.1 – Adolescent self-report of pain (VAS).

0.5

5.1*3.5

0.3

3.1 2.2

0

2

4

6

8

10

Baseline DressingRemoval

DressingApplicatio n

Mean painscore

Standard Deviation

Virtual Reality

Fig. 3.2 – Nursing staff behavioral of adolescent pain

(FLACC).

b u r n s 3 8 ( 2 0 1 2 ) 6 5 0 – 6 5 7654

However this difference was not seen during dressing

application, despite a lower mean score in the VRG (Fig. 3.2).

There were also no significant differences between the groups

for caregiver ratings of adolescent pain ( p > 0.05) (Fig. 3.3).

There were no statistically significant differences found

between the groups for mean heart rate or oxygen saturation

( p > 0.05). Notably, the VRG recorded rescue doses of Entonox

for 3/20 (15%) adolescents, whereas the SDG recorded 9/21

(43%) adolescents, representing a statistically significant

difference ( p = 0.05).

3.3. Adolescent reactions and adverse events

No adverse events relating to VR use were observed or

reported and there were no differences between groups for

nausea (Table 3). Throughout the dressing procedure, a large

proportion of adolescents reported significant pain (defined in

this and a previous similar trial as ‘‘moderate to severe’’ �4/10

on VAS [31,32]), and subsequently were recorded as experienc-

ing an adverse procedural pain event. More adolescents in the

2.3

6.3

1

4.5

0

2

4

6

8

10

Baseline DressinRemov

Mean painscore

Fig. 3.3 – Caregiver observation

SDG during dressing removal (15/21, 72%), and dressing

application (12/21, 58%) experienced a procedural adverse

pain event compared to the VRG (12/20, 60% during dressing

removal, and 6/19, 32% during dressing application, although

this difference was not significant ( p > 0.05). The mean

presence rated by all VRG participants (n = 20) using a VAS,

revealed a mean (SD) of 6.1 (�3.1) out of 10.

3.4. Length of treatment

Length of treatment times ranged from 2 to 62 min for

dressing removal and 2–58 min for dressing application. For

dressing removal both groups had a median time of 8 min

(VRG IQR = 4.5–15.5 min, and SDG IQR = 6–24 min). For dress-

ing application the VRG had a lower median time of

10 minutes (IQR = 4–20 min) compared to the SDG median

of 12 min (IQR = 9–20 min). A Mann–Whitney U test revealed

no significant difference between the groups for length of

removal ( p > 0.51) or application ( p > 0.33) of dressings (see

Fig. 3.4).

4.5

3.6

gal

DressingApplication

Standard Deviation

Virtual Reality

of adolescent pain (VAS).

5 100 15 20 25 30 35 40 45 50 55 60 65

VR

SD

VR

SD

Minutes

DressingRemoval

DressingApplication

Fig. 3.4 – Length of treatment times.

b u r n s 3 8 ( 2 0 1 2 ) 6 5 0 – 6 5 7 655

4. Discussion

This trial focused on non-pharmacological pain relief for the

underrepresented age range of adolescence in the context of

burn wound care. To the authors’ best knowledge this is the

first randomized controlled trial focusing on VR for adolescent

pain reduction during burn wound care. It provides valuable

insights into the clinical effectiveness and utility of an

affordable off-the-shelf VR system.

Firstly, the results demonstrated there were no consistent

statistically significant differences in pain during burn wound

care between groups. Notably for those adolescents in the

VRG, there was a statistically significant pain reduction

observed by nursing staff during dressing removal, a statisti-

cally significant reduction in the number of rescue Entonox

doses given, and a trend for the mean pain scores to be lower,

compared to the SDG. There was also overall consensus in

mean pain scores between adolescents, nursing staff and

caregivers, that dressing removal was more painful than

dressing application.

Fewer adolescents in the VRG were recorded as experienc-

ing an adverse procedural pain event, compared to the SDG.

While this off-the-shelf VR system was not effective in

significantly reducing pain, these are still promising clinical

benefits. The suggestion that VR can assist with pain reduction

during adolescent burn wound care, concurs with results from

previous trials and pilots involving the use of more customized

virtual reality related technologies with adolescent samples

[13,15] and children undergoing burn wound care [14,31]. This

trial highlights the limitations of affordable off-the-shelf

systems for engagement and distraction from pain.

This off-the-shelf system had no significant effect on

treatment times, compared to the standard distraction

options. The presence scores recorded during this trial while

positive still indicate room for improvement, in regard to the

level of immersion experienced by adolescents using this VR

system. In line with the gate control theory of pain [17], the

more attention that is engaged in virtual reality and distracted

away from the painful experience, the more effective the pain

relief. As greater pain reductions were reported in trials

involving customized systems [13–15,31], this guides the

direction of future research and development. For example

customizing a VR system to improve the motivational

relevance, as suggested by Verhoeven et al., may enhance

the effectiveness of distraction and subsequently enhance

pain reduction [33]. Another consideration for future research

which this trial did not focus on, is the impact of VR over

multiple and consecutive dressing changes. Information on

the longer term use of VR can provide meaningful insights

such as the impact on procedural anxiety and the mainte-

nance of reduced pain score for the first and subsequent

dressing changes [14].

Investigating the effectiveness and clinical usability of

affordable virtual reality systems is necessary in our current

economic climate and with growing health care demands.

This highlights the complexity of the pain experience and

fuels the ongoing discussion in the literature on what is the

minimum clinically meaningful reduction in pain [34–36], and

how much health systems will pay for it. This trial suggests

that savings made on purchasing an off-the-shelf system, will

not result in meaningful or effective reductions in pain.

Further research is required to confirm the minimum

clinically meaningful reduction in pain, and also identify

the qualities of a customized VR system that will engage

adolescents’ attention enough to reduce pain, as well as meet

burn wound procedure (i.e. infection control, waterproofing,

time, training and space implications) and financial require-

ments.

5. Limitations

Measurement of pain is challenging and assessment of pain

intensity alone does not capture the multidimensional nature

of pain. Due to the burden of other pain outcome measures

during a real life traumatic experience, only pain intensity was

assessed in this trial. Blinding of participants and staff is also

acknowledged as a limitation as it is extremely difficult to

achieve in trials with distraction interventions. Strategies to

reduce the impact include preventing participants from seeing

their allocated distraction intervention until in a private

treatment room.

6. Conclusions

This RCT of adolescents (11–17 years) using off-the-shelf VR

did not reduce pain levels, length of treatment times or

adverse pain events more than standard distraction. While

adolescents exposed to VR had a trend of lower mean pain

scores, the only difference that reached statistical significance

was for nursing staff observation during dressing removal.

Notably, the number of adolescents using off-the-shelf VR

received significantly fewer rescue doses of Entonox, com-

pared to those in the SDG. This paper highlights the need for

further investigation of customized VR which may further our

understanding of the relationship between VR distraction and

pain reduction in the adolescent age range.

Conflict of interest

This study was supported financially by a grant given to the

Royal Children’s Hospital, Brisbane by Diversionary Therapy

Technologies (DTT). DTT did not contribute in any way to the

b u r n s 3 8 ( 2 0 1 2 ) 6 5 0 – 6 5 7656

study design, data collection or analysis of results from this

clinical trial. Roy Kimble part-supervised this trial and also

holds options with this company, however at the time of

completion and submission of this clinical trial, will not stand

to lose or gain financially or personally from the results. The PI,

Kate Miller and Sylvia Rodger remain employees of the Royal

Children’s Hospital and University of Queensland respective-

ly, and have no financial interest in the results, products or

DTT.

Acknowledgments

Sincere thanks to Ristan Greer for her friendly encouragement

and statistical support, as well as the SPPBC and SPABU

nursing teams for their patience and assistance during this

project.

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