What this study is
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).
What's being tested
- Virtual Reality
Intervention · OTHER
Immersive and interactive game played through a portable head-mounted display as a distraction mechanism
Study details
- Sponsor
- Weill Medical College of Cornell University
- Conditions
- Pain
- Enrolling
- 50 people
- Starts
- 2018-06-01
- Est. completion
- 2027-05
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 8 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Diagnosis of a cognitive disorder, psychotic disorder or bipolar I as determined by self-report from previous diagnosis
- Current opioid abuse
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWeill Cornell Medicine
New York, New York, United States
- Olivia Baryluk, BS · Contact212-821-0783olb4002@med.cornell.edu
- JoAnn Difede, PhD · Principal investigator
Recruiting
Study team
Sponsor
Weill Medical College of Cornell University
Study ID 1610017629
Principal investigator
JoAnn Difede, PhD
Weill Medical College of Cornell University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.