Virtual Reality for Pain Management in Burn Patients
ConditionPain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8+
SponsorWeill Medical College of Cornell University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Diagnosis of a cognitive disorder, psychotic disorder or bipolar I as determined by self-report from previous diagnosis
Current opioid abuse
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality
Other interventionImmersive and interactive game played through a portable head-mounted display as a distraction mechanism
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Virtual RealityExperimental treatment 1 intervention
Group B: Treatment as UsualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Peri-procedural: 30 minutes before to two hours after the painful event.2
Change in narcotic dose
Dose of narcotics needed peri-procedure
Time frame
Peri-procedural: 30 minutes before to two hours after the painful event.Secondary outcomes
1
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
Time frame
Day 1 of hospitalization to last day of hospitalization (approximately 15 days)2
Change in anxiolytics dose
Determine if the one-time VR-distraction intervention reduces anxiolytic dose after painful event
Time frame
Day 1 of hospitalization to last day of hospitalization (approximately 15 days)3
Change in Anxiety Symptoms
Determined by visual analog scales (0-100) where 0 = no anxiety and 100 = worst possible anxiety.
Time frame
Peri-procedural: 30 minutes before to two hours after the painful event.4
Change in Depressive Symptoms
Determined by visual analog scales (0-100) where 0 = no depression and 100 = worst possible depression.
Time frame
Peri-procedural: 30 minutes before to two hours after the painful event.Sponsors and contacts
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Source ClinicalTrials.gov