VR for Pain Management During Adult Burn Dressing Change

Study Overview
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Brief Summary
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A randomized controlled trial to evaluate the efficacy of the VR-based Pain Alleviation Tool (VR-PAT) in reducing opioid pain medication use during adult burn dressing changes.

Detailed Description
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A pilot three group gender-balanced randomized clinical trial (RCT) among adult burn patients (18 years old or above) at OSU Medical Center Inpatient Burn Program. The intervention group will receive VR-PAT as a distraction tool during the dressing change procedure (active VR group) while the comparison groups will receive either a comparable passive VR distraction tool that uses the same hardware and visual/audio features, but requires no active interaction (Control Group 1), or no distraction at all (Control Group 2).

Official Title
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Virtual Reality Distraction to Reduce Opioid Pain Medication Use During Adult Burn Dressing Change

Conditions
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Pain, Burns

Intervention / Treatment
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* Other: VR-based Pain Alleviation Tool (VR-PAT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult burn patient age 18-70 First admission for acute burn requiring dressing change First admission for burn injury Using Opioids for dressing changes Burn is ≤ 4 days post burn Exclusion Criteria: Severe burn(s) on the face/head preventing utilization of VR Cognitive/motor impairment preventing valid administration of study measures Unable to communicate in English Prisoners and patients who were pregnant Patients admitted to the ICU

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Three-group RCT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active VR-PAT<br>Active VR-based Pain Alleviation Tool (VR-PAT) group played smart phone VR-PAT during the burn dressing changes. | Other: VR-based Pain Alleviation Tool (VR-PAT)<br>* Four smart phone based virtual reality games developed by the Research Information Solutions and Innovation (RISI) at the Nationwide Children's Hospital.<br>|
| Experimental: Passive VR-PAT<br>Passive VR-based Pain Alleviation Tool (VR-PAT) group watched smart phone VR-PAT games without interaction during the burn dressing changes. | Other: VR-based Pain Alleviation Tool (VR-PAT)<br>* Four smart phone based virtual reality games developed by the Research Information Solutions and Innovation (RISI) at the Nationwide Children's Hospital.<br>|
| No Intervention: Standard Care Control<br>Standard care control group used regular distraction such as background music or no distraction. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient self-reported pain | Patient self-reported pain using the 100mm Visual Analog Scale (VAS), 0 (min)-100(max), higher score for worse outcome. | During burn dressing changes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid medication utilization, morphine equivalent dose per day during inpatient hospital stay. | Opioid pain medication use (converted to morphine equivalent dose), obtained through patient medical administration records. This data will be used as morphine equivalent dose per day, total morphine-equivalent dose during hospital stay, and average morphine-equivalent dose among active VR group, passive VR group, and standard care group in comparison. | Each day during inpatient hospital stays up to 7 days. |