Virtual Reality for Pain Management in Burn Patients

NCT04685486 | Recruiting

• 1 other identifier: 1610017629
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain

Keywords

Virtual Reality; Pain Management; Anxiety; Depression

Outcome Measures

Primary Outcomes (2)

• 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.

• Change in narcotic dose

  Dose of narcotics needed peri-procedure

  Peri-procedural: 30 minutes before to two hours after the painful event.

Secondary Outcomes (4)

• Change in narcotic dose

  Day 1 of hospitalization to last day of hospitalization (approximately 15 days)

• Change in anxiolytics dose

  Day 1 of hospitalization to last day of hospitalization (approximately 15 days)

• Change in Anxiety Symptoms

  Peri-procedural: 30 minutes before to two hours after the painful event.

• Change in Depressive Symptoms

  Peri-procedural: 30 minutes before to two hours after the painful event.

Study Arms (2)

Virtual Reality

EXPERIMENTAL

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

Treatment as Usual

NO INTERVENTION

Standard of care during painful event (such as wound dressing changes or physical therapy sessions).

Interventions

Virtual Reality OTHER

Immersive and interactive game played through a portable head-mounted display as a distraction mechanism

Virtual Reality

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• Diagnosis of a cognitive disorder, psychotic disorder or bipolar I as determined by self-report from previous diagnosis
• Current opioid abuse

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Pain; Agnosia; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• JoAnn Difede, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivia Baryluk, BS

CONTACT

212-821-0783; olb4002@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: June 1, 2018
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)