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Recruiting NCT04685486

Virtual Reality for Pain Management in Burn Patients

No phase Interventional Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality.
Who it may be relevant to
Registry conditions: Pain. Basic parameters: from 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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

Primary outcome measures

  • Change in Pain [Time frame: Peri-procedural: 30 minutes before to two hours after the painful event.]
  • Change in narcotic dose [Time frame: Peri-procedural: 30 minutes before to two hours after the painful event.]
Secondary outcome measures (4)
  • Change in narcotic dose [Time frame: Day 1 of hospitalization to last day of hospitalization (approximately 15 days)]
  • Change in anxiolytics dose [Time frame: Day 1 of hospitalization to last day of hospitalization (approximately 15 days)]
  • Change in Anxiety Symptoms [Time frame: Peri-procedural: 30 minutes before to two hours after the painful event.]
  • Change in Depressive Symptoms [Time frame: Peri-procedural: 30 minutes before to two hours after the painful event.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Weill Cornell Medicine — New York

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. PMID 41942793

Identifiers

NCT: NCT04685486 · 1610017629

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗