Virtual Reality for Pain Management in Burn Patients

Pain Clinical Trial

Official title:

Virtual Reality for Pain Management in Burn Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04685486
• Other study ID #: 1610017629
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: March 2025

Study information

• Verified date: September 2023
• Source: Weill Medical College of Cornell University
• Contact: Olivia Baryluk, BS
• Phone: 212-821-0783
• Email: olb4002[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Virtual Reality
Immersive and interactive game played through a portable head-mounted display as a distraction mechanism

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Peri-procedural: 30 minutes before to two hours after the painful event.
Primary	Change in narcotic dose	Dose of narcotics needed peri-procedure	Peri-procedural: 30 minutes before to two hours after the painful event.
Secondary	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	Day 1 of hospitalization to last day of hospitalization (approximately 15 days)
Secondary	Change in anxiolytics dose	Determine if the one-time VR-distraction intervention reduces anxiolytic dose after painful event	Day 1 of hospitalization to last day of hospitalization (approximately 15 days)
Secondary	Change in Anxiety Symptoms	Determined by visual analog scales (0-100) where 0 = no anxiety and 100 = worst possible anxiety.	Peri-procedural: 30 minutes before to two hours after the painful event.
Secondary	Change in Depressive Symptoms	Determined by visual analog scales (0-100) where 0 = no depression and 100 = worst possible depression.	Peri-procedural: 30 minutes before to two hours after the painful event.