Virtual Reality for Pain Management in Burn Patients
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Virtual Reality 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
Immersive and interactive game played through a portable head-mounted display as a distraction mechanism
|
| No Intervention: Treatment as Usual Standard of care during painful event (such as wound dressing changes or physical therapy sessions). |
Outcome Measures
Primary Outcome Measures
- Change in Pain [Peri-procedural: 30 minutes before to two hours after the painful event.]
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.
- Change in narcotic dose [Peri-procedural: 30 minutes before to two hours after the painful event.]
Dose of narcotics needed peri-procedure
Secondary Outcome Measures
- Change in narcotic dose [Day 1 of hospitalization to last day of hospitalization (approximately 15 days)]
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
- Change in anxiolytics dose [Day 1 of hospitalization to last day of hospitalization (approximately 15 days)]
Determine if the one-time VR-distraction intervention reduces anxiolytic dose after painful event
- Change in Anxiety Symptoms [Peri-procedural: 30 minutes before to two hours after the painful event.]
Determined by visual analog scales (0-100) where 0 = no anxiety and 100 = worst possible anxiety.
- Change in Depressive Symptoms [Peri-procedural: 30 minutes before to two hours after the painful event.]
Determined by visual analog scales (0-100) where 0 = no depression and 100 = worst possible depression.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Weill Cornell Medicine | New York | New York | United States | 10065 |
Sponsors and Collaborators
- Weill Medical College of Cornell University
Investigators
- Principal Investigator: JoAnn Difede, PhD, Weill Medical College of Cornell University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1610017629