Recruiting

Virtual Reality

Sponsor:

Weill Medical College of Cornell University

Code:

NCT04685486

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

Interventions

Virtual Reality

Study Details

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

Study ID

NCT04685486

Start date

Jun 1, 2018

Status verified date

Jun, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

no intervention: Treatment as Usual

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

Interventions

Virtual Reality

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

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Olivia Baryluk, BS

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

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Olivia Baryluk, BS

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

Principal Investigator:

JoAnn Difede, PhD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

  • Virtual Reality
  • Pain Management
  • Anxiety
  • Depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-06-17.