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NCT Number: NCT04685486

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).

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Key information

Conditions

Pain Agnosia Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10065, United States

Location status: Recruiting

Location contact

JoAnn Difede, PhD

PRINCIPAL_INVESTIGATOR

Olivia Baryluk, BS

CONTACT

[email protected]

212-821-0783

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality

Other

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

Primary outcomes

  1. Change in Pain

    Time frame: 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.

  2. Change in narcotic dose

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

    Dose of narcotics needed peri-procedure

Secondary outcomes

  1. Change in narcotic dose

    Time frame: 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

  2. Change in anxiolytics dose

    Time frame: 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

  3. Change in Anxiety Symptoms

    Time frame: 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.

  4. Change in Depressive Symptoms

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Olivia Baryluk, BS

CONTACT

[email protected]

212-821-0783

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Dec 28, 2020
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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