VR for Pediatric Burn Dressing Changes

Study Overview
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Brief Summary
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This study evaluated a smart phone virtual reality (VR) to manage pediatric burn dressing pain. A randomized controlled trial was conducted among 90 patients (6-17 years). Active VR participants played the game, passive VR group were immersed in the same VR without interactions, and a standard care group served as the control. One researcher administered VR and observed pain while another researcher administered post-trial survey that measured child's perceived pain and VR experience. Nurses were asked to report the clinical utility.

Official Title
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Active and Passive Virtual Reality Distraction for Pain Management During Pediatric Burn Dressing Changes

Conditions
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Pain, Burns

Intervention / Treatment
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* Other: Virtual reality game as adjunctive pain management tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children age 6-17 years (inclusive) admitted or seen in the outpatient clinic for a burn injury spoke English as primary language Exclusion Criteria: a severe burn on the face or head that prevented the utilization of the VR cognitive or motor impairment that prevented valid administration of study measures visual or hearing impairments that prevented interaction with the VR environment did not have a legal guardian present to give consent

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, three-group between subject randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active VR<br>Participants in the active VR group played a virtual reality game entitled Virtual River Cruise. In this game, an otter floats down a river on a boat and players activate snow-blowing statues along the shore by focusing on them. The statues will emit snow if they are correctly aimed at by the child, and a thermometer placed in the front of the boat shows decreased temperatures as more snowflakes are blown. As feedback to reinforce continued engagement, a scoreboard placed beside the thermometer will show children the number of statues he/she has activated. Additionally, as the temperature drops, snow and ice will start piling up on the boat and its surroundings, providing an enhanced cooling experience for pediatric burn patients. Children interact with the immersive virtual reality environment by tilting their head, minimizing potential interference with the dressing change procedure. | Other: Virtual reality game as adjunctive pain management tool<br>* A smart phone virtual reality-based pain alleviation tool (VR-PAT).<br>|
| Experimental: Passive VR<br>Participants in the passive VR group were immersed in the same virtual reality environment as the active VR group, without any interactions with the VR game. | Other: Virtual reality game as adjunctive pain management tool<br>* A smart phone virtual reality-based pain alleviation tool (VR-PAT).<br>|
| No Intervention: Standard Care Control<br>Participants in the standard group received routinely used distraction tools provided in the clinical setting, such as iPads, music, books, and/or talking. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed pain | Researcher observed pain of patient based on the Face Legs Activity Cry and Consolability behavioral pain assessment tool (FLACC-r), using 0,1,2 numerical scale for category of face, legs, activity, cry, and consolability. Total scores range from 0-10 with higher scores indicating more pain. | During outpatient burn dressing change, on average lasting about 15 minutes. | 
| Patient self-reported pain | Patient-perceived pain using 0-100 scale Visual Analog Scales (VAS), 0(min)-100(max), higher score for worse outcome. | During outpatient burn dressing change, on average lasting about 15 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VR experience self-reported by patient and parents | Self-reported virtual reality experience using patient and parent survey questions (5-6 survey items) about their experience in using virtual reality during burn wound care. Questions are a mixture of yes/no and a 100 Visual Analog Scale (VAS) with 0 being Not at All and 100 being Very Much | During outpatient burn dressing change, on average lasting about 15 minutes. | 
| Simulator sickness symptoms of patient | Simulator sickness symptoms using the Simulator Sickness Questionnaire (SSQ), which has 15 survey items with possible choices of None, Slight, Moderate, and Severe. | During outpatient burn dressing change, on average lasting about 15 minutes. | 
| Nurse reported feasibility of VR in clinical burn wound care | Attending nurse answered two questions using a survey questionnaire about clinical feasibility of VR using scale ranging from not at all to very easy. | During outpatient burn dressing change, on average lasting about 15 minutes. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatrics, Burns, Pain, Virtual Reality