A Pilot Study to Assess the Feasibility and the Preliminary Efficacy of a Virtual Reality Distraction Intervention for Pain Management and Anxiety in Children With Burn Injuries During Hydrotherapy
Phase: NA
Conditions: Burn, Child, Pain, Anxiety
Sponsor: St. Justine's Hospital

Title of the study: Virtual Reality Distraction for Procedural Pain Management and Anxiety in 
Children With Burn Injuries: A Pilot Study  
 
NCT number: NCT02794103 
 
Principal Investigator: Sylvie Le May, RN, PhD  
Co-Investigators: Christelle Khadra, RN, PhD (c), Sylvie Charette, RN, MSc, Edith Villeneuve, 
MD, Johanne Déry, PhD, Lucie Farmer, BSc, Patricia Garrel, MD, Claude Fortin, MSc, Jean-
Simon Fortin, MD, Isabelle Perreault, MD  
 
Protocol version: May 2016  
 
 

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BACKGROUND  
The burden of burns and pain. Burn injuries are among the leading causes of visits to the 
emergency department and hospitalizations in young children. They mostly result from scalds and 
contact with household appliances. Regardless the cause of the injury, dressing changes and 
hydrotherapy sessions for burn injuries are associated with extreme pain. The management of acute 
pain experienced during hydrotherapy sessions in patients with burn injuries, called procedural 
pain, remains a major challenge for healthcare professionals. Pain can have several short term 
effects on the child on the development, mood, sleep, appetite, school performance, anxiety and 
distress levels. In the long term, it can decrease the pain threshold, cause stress disorders, affect 
social behavior and seeking of medical services. In burn injuries, pain is often accompanied by 
great anxiety, which in turn, decreases pain tolerance. To relieve pain and anxiety, clinicians 
usually rely on pharmacological agents via the administration of high doses of opioids and 
anxiolytics. The use of these medications can cause deep sedation in children, and many side 
effects such as nausea, vomiting, and respiratory depression. Also, despite the growing use of 
opioids, patients report pain of more than 7 on a scale of 0-10 during their dressing changes and 
hydrotherapy sessions. Multimodal approaches combining medication and non-pharmacological 
interventions should be explored to reduce pain and anxiety associated with painful procedures.  
Innovation of non-pharmacological pain interventions. Studies and reviews have highlighted, 
in recent years, the effectiveness of multimodal approaches combining medication with non-
pharmacological interventions for procedural pain relief. Distraction techniques have been 
recognized among the most effective non-pharmacological interventions. They divert the child's 
attention to an attractive element, hindering the perception of the painful stimuli and therefore 
reducing pain and anxiety. Distraction is based on the gate control theory of Melzack and Wall 
stating a link between perception of pain and level of attention devoted to the stimulus affecting 
the painful experience. Therefore, distraction techniques engaging multiple senses such as vision 
and audition may grab the child`s attention more than the techniques that only engage one sense. 
Hence, the increasing interest in more immersive and interactive methods of distraction such as 
virtual reality (VR) for the management of procedural pain.  
Virtual reality distraction. This is an active distraction method that allows the user to interact 
with an immersive environment generated by a computer stimulating different senses (vision, 

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hearing and sometimes touch). VR allows a mental escape through multisensory interaction. Its 
effect is known to decrease pain and anxiety. In the past ten years, VR was tested through different 
studies with older children and adult burn victims. A study by Hoffman et al. in 2007, showed that 
the percentage of reduction in pain by VR was comparable to the reduction resulting from a 
moderate dose of hydromorphone equivalent to what a patient would receive during a burn wound 
care. Yet, the authors state that they believe the best analgesia is achieved by combining VR with 
pharmacological treatment. However, very few studies have tested the effect of a combination of 
pharmacological and virtual reality interventions, on procedural pain and anxiety of young children 
suffering from burn injuries. Also, current studies on VR mostly use 3D goggles or helmets in 
contact or close to the face of the child which could be challenging with young children since they 
mostly have burns on their face and upper trunk. Therefore, a new VR prototype has been 
developed in collaboration with the Society of Arts and Technology (SAT) in Montreal to provide 
an immersive interactive experience for the burn child in the hydrotherapy tank. The prototype 
was developed after several meetings between the researchers, the designers and engineers and the 
surgical-trauma team of CHU St. Justine. Meetings were followed by an ergonomic study of the 
hydrotherapy room to meet the unit's and patients' specifications and ensure that it doesn't interfere 
with the healthcare professionals work.  
 
AIM  
The aim of this pilot study is to assess the feasibility and applicability of the prototype as well as 
the satisfaction of the healthcare professionals regarding the use of the VR prototype for the relief 
of procedural pain and anxiety in young children with burn injuries.  
Primary Research Question: In children from 2 months to 10 years old who have suffered burn 
injuries, is VR distraction a feasible, applicable and satisfactory method for pain relief during 
hydrotherapy? Secondary Research Question: In children from 2 months to 10 years old who have 
suffered burn injuries, does VR distraction provide better pain and anxiety relief during 
hydrotherapy than standard pharmacological treatment?  
 
 

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HYPOTHESES  
a. VR distraction is a feasible and acceptable non-pharmacological method for procedural pain 
relief (during hydrotherapy) of young children with burn injuries.  
b. VR distraction combined with analgesics is more efficacious than standard treatment (analgesics 
alone) on procedural pain and anxiety (during hydrotherapy) of young children with burn injuries.  
 
METHODS  
Design. Single-arm pilot study.  
Sample and Setting. Participants will be recruited through convenience sampling upon admission 
to the surgical-trauma burn unit. The unit has a hydrotherapy room for inpatients and outpatients. 
Healthcare professionals usually present during hydrotherapy are: a burn wound care nurse, a nurse 
clinician from the pain clinic, an anesthetist, a physical therapist and an orderly. The size of the 
total desired sample is 15 to 20 participants depending on the recruitment rate since it is a pilot 
study. The study will take place in the hydrotherapy room of the CHU St. Justine, a large pediatric 
university teaching hospital in Montreal where the VR prototype is installed.  
Eligibility criteria. Inclusion criteria: children from 2 months to 10 years old, with a burn injury, 
requiring a hydrotherapy session for burn wound care, and accompanied by a consenting 
parent/legal tutor who can understand, read, and write either French or English. Exclusion criteria: 
1) Admitted to the intensive care Unit, 2) Neuro-cognitive disability that precludes children from 
interacting with the distraction intervention, 3) Unconscious or intubated during hydrotherapy 
session, 4) Suffering from epilepsy (considering the nature of the intervention), 5) Allergic to 
opioids or other analgesics used for standard pharmacological treatment.  
Intervention: The child will visualize and interact with the virtual environment throughout the 
hydrotherapy session. VR prototype developed by the SAT will be used as the experimental 
intervention. It has a wide screen installed at the end of the hydrotherapy tank offering a 150-
degree field view, on which appears a game allowing the child to have the immersive entertainment 
experience without the need to wear a helmet or 3D glasses. The child or a proxy, depending on 
age and burn site, will have the opportunity to interact with the game. The interactive component 
is not mandatory for the immersive and distractive experiences provided by the prototype. Video 

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games tailored to the child's age and injury, different from the commercially available ones, will 
be adapted to each age-group of children recruited with control over the speed of movement to 
avoid motion sickness.  
Measures. Measures of baseline pain and anxiety will be recorded at T1, 30 minutes before the 
procedure, in the patient`s room. Measures for procedural pain, anxiety and sedation level will be 
taken at: T2, before the procedure, upon arrival in the hydrotherapy room, T3, during the procedure 
(10 min after the beginning of the hydrotherapy session), T4, immediately after the procedure 
before leaving the hydrotherapy room and T5, 30 minutes after the procedure in the patient`s room. 
The patient`s comfort level will also be assessed during the procedure at T3. Finally, the 
acceptability of the intervention will be assessed through a questionnaire comprising items on the 
acceptability and satisfaction of the healthcare professionals at T4. The same measures will be 
recorded for each participant for up to three hydrotherapy sessions. The primary outcome will be 
the acceptability of the intervention. Comparisons will be made between pain and anxiety levels 
for the same order of session.  
A) Primary Outcome Measure: Acceptability [Time Frame: T4, immediately after the procedure 
before leaving the hydrotherapy room]: To assess the acceptability including the satisfaction of 
healthcare professionals regarding the use of the VR prototype during the hydrotherapy session. 
Pre-tested tailored questionnaire including satisfaction and acceptability outcomes (tolerance, 
positive and negative aspects, secondary effects).  
B) Secondary Outcome Measures:  
1) Pain intensity [Time Frame: T1, 30 minutes before the procedure (patient`s room); T2, upon 
arrival at the hydrotherapy room; T3, 10 min after the beginning of the hydrotherapy session; T4, 
immediately after the session before leaving hydrotherapy room; T5, 30 min. after the session]: 
Face, Legs, Activity, Cry and Consolability (FLACC).  
2) Anxiety Level [Time Frame: T2, upon arrival at the hydrotherapy room; T3, 10 min after the 
beginning of the hydrotherapy session; T4, immediately after the session before leaving 
hydrotherapy room; T5, 30 min. after the session]: Procedure Behaviour Check List (PBCL).  

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3) Comfort Level [Time Frame: T3, during the procedure (10 min after the beginning of the 
hydrotherapy session)]: Behavioural observation scale of comfort level for child burn victims 
(OCCEB- BECCO).  
4) Analgesic requirement [Time Frame: T3, during the procedure (10 min after the beginning of 
the hydrotherapy session)]: rescue dose medication administration.  
5) Sedation level [Time Frame: T2, before the procedure, upon arrival in the hydrotherapy room, 
T3, during the procedure (10 min after the beginning of the hydrotherapy session), T4, immediately 
after the procedure before leaving the hydrotherapy room]: Ramsay sedation scale.  
6) Baseline anxiety level [Time Frame: T1, 30 minutes before the procedure, in the patient`s room]: 
Modified Smith Scale.  
 
FEASIBILITY  
The setting of the study is the main referral center for pediatric burns in Quebec. It receives nearly 
60 admissions during the period when there is a higher incidence of burns (April to October) and 
almost 100 admissions per year. The investigators will be able to access the population for the 
study given the PI's affiliation to the research center of this setting. Moreover, stakeholders in the 
pain clinic and surgical-trauma unit are aware of the study, and participated in all stages of the 
prototype development.  
 
POSSIBLE PITFALLS AND SOLUTIONS  
It is unknown whether the VR is a feasible distraction technique in young children/infants aged 
between 2 months and 2 years old. The pilot study will help inform the investigators about the 
visual tracking in infants during painful medical procedures. Upon completion of the pilot study, 
it will be decided whether to include or not the young population in the larger trial.  
 
CONTRIBUTION AND EXPECTED RESULTS  
Despite growing interest in the field, procedural pain management in children remains suboptimal 
and the importance of developing more effective methods is required. This project will provide 

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preliminary evidence on the feasibility, acceptability, and preliminary efficacy of non-
pharmacological methods of procedural pain management through the development and testing of 
innovative interventions. VR distraction could be an interesting method to relieve pain, easy to use 
and without known side effects. The investigators hope that it could reduce the need for opioids 
and anxiolytics in burn children and decrease the pain related to the procedures while providing a 
less traumatizing hospital experience, which is often the first for children under 5 years old. The 
expected results have a direct effect on physical (pain, comfort) and psychological (anxiety) health 
of the child. In addition, clinical implications may include other indicators of quality of care and 
economic benefits such as duration of the hydrotherapy session, the amount of opioids and anxiety 
drugs administered, the use of coanalgesics, the number of professionals required in the 
hydrotherapy room and duration of wound healing.  
 
DATA ANALYSIS PLAN  
Descriptive statistics will be performed for sociodemographic and clinical variables, comfort 
levels and the satisfaction of health professionals. Non-parametric inferential statistics will be used 
to compare the mean differences in pain scores before, during and after the procedure as well as 
for anxiety and level of sedation. Since the use of rescue medication is a potential indication of a 
treatment failure, the analysis will be supplemented by an analysis comparing the proportion of 
patients receiving rescue medication anytime during the procedure. Interpretation of the analyses 
will be made with reference to the data regarding rescue medication use. Data collected on 
dichotomous variables will be analyzed using a chi-square test and post-hoc analyses if the results 
are statistically significant.