VR for Burn Dressing Changes at Home

Study Overview
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Brief Summary
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This study will evaluate the impact of our smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) during the repeated at-home burn dressing changes of children (5-17 years) with a burn injury in comparison with a control group of children with a burn injury who will not use VR-PAT during at-home burn dressing changes. We hypothesize that children using VR-PAT will report less pain during their dressing changes.

Detailed Description
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Subjects will be randomly assigned to either the VR-PAT intervention group or Control group. Subjects and caregivers in both groups will perform daily dressing changes (as prescribed by their physician) and afterward will answer questions about their pain and any medications used. Subjects and caregivers in the intervention group will answer additional questions about their experience using the VR-PAT, ease of use, and helpfulness. Surveys will be repeated with each dressing changes for one week.

Official Title
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Mobile Phone Virtual Reality Game for Pediatric Home Burn Dressing Pain Management

Conditions
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Burns, Acute Pain, Procedural Pain

Intervention / Treatment
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* Device: VR-PAT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pediatric patients age 5-17 years (inclusive) receiving first outpatient dressing change or being discharged from the inpatient burn unit at our institution have a dressing that requires daily changes at home for at least one week can communicate orally Exclusion Criteria: any wounds that may interfere with study procedures (i.e. face) vision, hearing, or cognitive/motor impairments preventing valid administration of study measures history of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras minors in foster care suspected child abuse unable to communicate in English families who do not have access to a smartphone (due to the VR-PAT game requirements)

Ages Eligible for Study
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Minimum Age: 5 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR-PAT<br>Virtual Reality administered during burn dressing changes | Device: VR-PAT<br>* Smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) via a lightweight, mobile VR headset<br>* Other names: Virtual Reality;|
| No Intervention: Control<br>Dressing changes performed without Virtual Reality (other distraction methods available in the home allowed). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment during dressing changes. | 1-10 rating scale (self-reported and caregiver-reported), 1(min)-10(max), with higher score indicating worse outcome. | 15-30 minutes during daily burn dressing changes for up to 7 days. | 
| Observed VR experience. | caregiver-reported subject's engagement with VR (VR-PAT arm only) using a 5-item parent questionnaire. | Daily for 15-30 minutes burn dressing change for up to 7 days. | 
| Self-reported VR experience. | 1-10 rating scale of degree of realism, pleasure, and satisfaction with VR (VR-PAT arm only), with higher score meaning better outcome. | Daily for 15-30 minutes burn dressing change for up to 7 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burn-related medications | caregiver-reported name and dosage of medication provided for burn-related pain | Daily for burn dressing change for up to 7 days. | 

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