Virtual Reality for Pain Management in Burn Patients

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).

Study Overview

• Status: Recruiting
• Conditions: Pain
• Intervention / Treatment: Other: Virtual Reality

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivia Baryluk, BS; Phone Number: 212-821-0783; Email: olb4002@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medicine
      • Contact: Olivia Baryluk, BS; Phone Number: 212-821-0783; Email: olb4002@med.cornell.edu
      • Principal Investigator: JoAnn Difede, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Virtual Reality; Immersive and interactive game played through a portable head-mounted display as a distraction mechanism
No Intervention: Treatment as Usual; Standard of care during painful event (such as wound dressing changes or physical therapy sessions).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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.
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.

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: JoAnn Difede, PhD, Weill Medical College of Cornell University

Publications and helpful links

General Publications

• Emrich M, McAleavey AA, Wyka K, Greenway A, Houng AP, Chang PH, Zhou C, Difede J. Feasibility of Mobile Phone-Based Virtual Reality as a Non-pharmacologic Acute Procedural Pain Management Intervention in an Inpatient Burn Center. J Clin Psychol Med Settings. 2026 Jun;33(2):381-392. doi: 10.1007/s10880-026-10146-z. Epub 2026 Apr 6.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Virtual Reality; Pain Management
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Pain; Anxiety Disorders; Depression; Agnosia
• Other Study ID Numbers: 1610017629

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No