Pain
Conditions
Keywords
Virtual Reality, Pain Management, Anxiety, Depression
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).
Interventions
OTHERVirtual Reality
Immersive and interactive game played through a portable head-mounted display as a distraction mechanism
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTOlivia Baryluk, BS
PRINCIPAL_INVESTIGATORJoAnn Difede, PhD
Weill Medical College of Cornell University
Outcome results
None listed