Virtual Reality for Pain Management in Burn Patients

Study Overview
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Brief Summary
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This study is a randomized proof-of-concept study to assess the efficacy of Virtual Reality (VR) vs standard of care in 50 adult patients in the New York Presbyterian Burn Unit. The participants who are randomized to receive the virtual reality intervention will also receive opioids, which is the standard of care and is known to be effective. Participants will be randomly assigned to two groups. The first group will receive VR during their painful procedure (e.g., wound dressing changes, physical therapy etc.) in addition to the standard of care. The other group will receive standard of care (and no VR).

Official Title
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Virtual Reality for Pain Management in Burn Patients

Conditions
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Pain

Intervention / Treatment
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* Other: Virtual Reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 8 years and older Patients with a burn injury and is in the Burn Unit at New York Presbyterian Awake, alert, ambulatory The burn comprises less than 15% total body surface area (TBSA) The patient does not require conscious sedation such as ketamine for staple removal or wound dressing changes The patient is able to give informed consent Exclusion Criteria: Diagnosis of a cognitive disorder, psychotic disorder or bipolar I as determined by self-report from previous diagnosis Current opioid abuse

Ages Eligible for Study
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Minimum Age: 8 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: Virtual Reality<br>Virtual reality-enhanced distraction using a portable head mounted display during panful events (such as wound dressing changes or physical therapy sessions) in addition to standard of care. | Other: Virtual Reality<br>* Immersive and interactive game played through a portable head-mounted display as a distraction mechanism<br>|
| No Intervention: Treatment as Usual<br>Standard of care during painful event (such as wound dressing changes or physical therapy sessions). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain | Initial determination of the clinical efficacy of VR in reducing the total pain (determined by the subjective standard 0-10 pain scale) where 0 = no pain and 10 = worst pain. | Peri-procedural: 30 minutes before to two hours after the painful event. | 
| Change in narcotic dose | Dose of narcotics needed peri-procedure | Peri-procedural: 30 minutes before to two hours after the painful event. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in narcotic dose | Determine if the one-time VR-distraction intervention reduces dose of analgesics for the day after the painful events and the remained of the post-procedure hospitalization | Day 1 of hospitalization to last day of hospitalization (approximately 15 days) | 
| Change in anxiolytics dose | Determine if the one-time VR-distraction intervention reduces anxiolytic dose after painful event | Day 1 of hospitalization to last day of hospitalization (approximately 15 days) | 
| Change in Anxiety Symptoms | Determined by visual analog scales (0-100) where 0 = no anxiety and 100 = worst possible anxiety. | Peri-procedural: 30 minutes before to two hours after the painful event. | 
| Change in Depressive Symptoms | Determined by visual analog scales (0-100) where 0 = no depression and 100 = worst possible depression. | Peri-procedural: 30 minutes before to two hours after the painful event. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Pain Management, Anxiety, Depression