VR-PAT During Home Burn Dressings - Multisite

Study Overview
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Brief Summary
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This study will evaluate the effectiveness of smartphone Virtual Reality Pain Alleviation Therapy (VR-PAT) as a pain distraction tool during repeated at-home burn dressing changes among 100 children (age 6-17 years) with a burn injury in comparison to 100 children with a burn injury who do not use the VR-PAT.

Detailed Description
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In this two-group randomized clinical trial, participants will be randomly assigned to either the VR-PAT intervention group or control group (standard distraction techniques available in the home). Participants and caregivers in both groups will perform daily burn dressing changes (as prescribed by their physician) and afterward will answer questions about their pain and any medications used. Participants 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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A Randomized Clinical Trial of Smartphone Virtual Reality for Pain Management During Burn Care Transition

Conditions
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Burns, Acute Pain, Procedural Pain, Injuries, Pediatric ALL

Intervention / Treatment
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* Other: VR-PAT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being treated for acute burn injury Age 6-17 years, inclusive Receiving their first outpatient clinic dressing change or being discharged from the ED or inpatient burn unit Have a dressing that requires daily changes at home for at least 7 days after their first outpatient appointment or discharge from the hospital (ED or inpatient) Patient and family caregivers can communicate (read and write) using English or Spanish Reported at least moderate or worse NRS pain score of ≥3 (NRS 0-10 with 10 being worst pain) from the most recent dressing change. Exclusion Criteria: Any wounds that may interfere with study procedures 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, prisoners, or currently pregnant Suspected child abuse Families who do not have access to a VR compatible smartphone.

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Participants will be using the VR-PAT during burn dressings. | Other: 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 Group<br>Participants will not be using the VR-PAT during burn dressings (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 |
| --- | --- | --- |
| Change in self-reported pain | 0-10 Numerical Rating Scale (NRS) (self-reported and caregiver-reported), 0(min)-10(max), with higher score indicating worse pain. Asked for worst pain, average pain, and time spent thinking about pain. | Immediately following each dressing change for one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported VR experience | 0-10 Numerical Rating Scale (NRS) (self-reported - VR-PAT arm only), 0(min)-10(max), with higher score meaning better outcome. Asked for degree of realism, pleasure, and satisfaction with VR. | Immediately following each dressing change for one week | 

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