Virtual Reality for Pain Management in Burn Patients

NCT ID: NCT04685486

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2026-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type OTHER

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

Treatment as Usual

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual Reality

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JoAnn Difede, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medicine

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Olivia Baryluk, BS

Role: CONTACT

212-821-0783

Facility Contacts

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Olivia Baryluk, BS

Role: primary

212-821-0783

Other Identifiers

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1610017629

Identifier Type: -

Identifier Source: org_study_id

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