Virtual Reality Analgesia for Pediatric Burn Survivors

Study Overview
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Brief Summary
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Many children with large severe burns report severe pain during burn wound cleaning. The current study explores whether adjunctive immersive Virtual Reality distraction may help reduce the intensity of pain experienced by children during burn wound cleaning by taking the patient's mind off their pain.

Detailed Description
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All patients always receive their usual pain medications. Using a within-subjects, within-wound care design, in the current study, pediatric patients being treated for severe burn injuries will receive music distraction during some portions of their wound care (active comparator condition), and they will receive what we predict will be an unusually strong distraction, immersive virtual reality (the experimental treatment) during other comparable portions of the same wound cleaning sessions. During virtual reality, each patient will look into virtual reality goggles, and will play a simple cartoon-like virtual reality game SnowWorld during burn wound cleaning. After each wound care session, the patient will rate how much pain they experienced during wound care during No VR (music only) compared to how much pain they experienced during wound care during virtual reality, on each study day, for up to 10 study days per patient. Treatment order randomized.

Official Title
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Virtual Reality Analgesia for Pediatric Burn Survivors

Conditions
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Pain, Acute

Intervention / Treatment
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* Behavioral: virtual reality distraction (Yes VR)
* Behavioral: music distraction (No VR)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Compliant and able to complete subjective evaluations, A minimum of 10% of total burned surface area, No history of psychiatric (DSM-III-R Axis I) disorder(s), Not demonstrating delirium, psychosis or any form of organic brain disorder, Able to communicate verbally in English or Spanish, Admitted to UTMB/Shriners, 6-17 years of age. Exclusion criteria: No wound cleaning sessions required. Less than 10% of total burned surface area. History of psychiatric (DSM-III-R Axis I) disorder(s). Demonstrating delirium, psychosis or organic brain disorder. Unable to communicate verbally in English or Spanish. History of significant cardiac, endocrine, neurologic, metabolic, respiratory, gastrointestinal, or genitourinary impairment. Receiving prophylaxis for alcohol or drug withdrawal, Developmental disability, Younger than 6 years; older than 17 years, Burns of eyes, eyelids or face so severe they preclude the use of VR, Worst pain intensity of less than 5 on a 0 to 10 scale, during baseline No VR wound care Day 1.

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: Crossover Assignment
Interventional Model Description: Within-subject design with repeated measures, with random assignment to initial treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: virtual reality distraction (Yes VR)<br>In addition to their standard pain medications, patients will play a virtual realty game named SnowWorld during some portions of their burn wound cleaning procedure, on each study day. | Behavioral: virtual reality distraction (Yes VR)<br> <br> |
| Active Comparator: music distraction (No VR condition)<br>In addition to their standard pain medications, patients will listen to music during comparable portions of their burn wound cleaning procedure, on each study day. | Behavioral: music distraction (No VR)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worst Pain rating of pain intensity during Music vs. during VR | worst pain during wound care. This single question measures the sensory component of pain during wound care. Patients will rate their worst pain during burn wound care. on a zero to ten scale, where zero is no pain at all  and 10 is excruciating pain. Lower scores represent better outcome. No subscales. | measured after burn wound care on each study day for up to 10 study days per patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graphic Rating Scale Time spent thinking about pain during Music vs. during VR | This single question measures the Cognitive component of pain during wound care. Patients will rate how much time they spent thinking about pain during burn wound care, on a zero to ten scale, where zero is no time at all and 10 is the entire time. Lower scores represent better outcome. No subscales. | measured after burn wound care on each study day for up to 10 study days per patient | 
| Graphic Ratings Scale measure of pain unpleasantness during Music vs. during VR | This single question measures the emotional component of pain. On a scale from zero to ten, where zero is not unpleasant at all, 10 is excruciatingly unpleasant. Lower scores represent better outcome. No subscales. | measured after woundcare on each study day for up to 10 study days per patient | 
| Graphic Rating Scale Fun during Music vs. during VR | This single question measures positive affect during burn wound care. On a zero to ten scale, where zero is no fun at all and 10 is extremely fun. Higher scores represent better outcome. No subscales. | measured after wound care on each study day for up to 10 study days per patient | 
| Graphic Rating Scale Satisfaction with pain management during Music vs. during VR | This single question measures how satisfied the patient is with how well their pain was controlled during burn wound care. Higher scores represent better ourcomes. No subscales | Measured after wound care on Study Day 1. | 
| Child Health Questionnaire | Child Health Questionnaire The Child Health Questionnaire (CHQ) is a family of generic QOL instruments. The CHQ includes 87 scales that consider the effects of children's health on family functioning, and specific scales such as behavior and self-esteem. The CHQ measures 14 unique physical and psychosocial concepts. Questionnaires will be self-completed by the outpatients or parents, or both. Raw scores will converted to scaled scores from zero to 100. Higher scores indicate better health and better quality of life outcome. | measured at 0, 9 months and 12 month followup visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid, virtual reality pain, pediatric burn, wound care