Virtual Reality for Pain Management in Burn Patients

Not Applicable

Recruiting

• Conditions: Pain
• Interventions: Other: Virtual Reality

• Registration Number: NCT04685486
• Lead Sponsor: Weill Medical College of Cornell University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19
• Primary Completion: 2026-01
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality	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.

Primary Outcome Measures

Name	Time	Method
Change in narcotic dose	Peri-procedural: 30 minutes before to two hours after the painful event.	Dose of narcotics needed peri-procedure
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.

Secondary Outcome Measures

Name	Time	Method
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 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 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.
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

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States