PainNCT04685486
Virtual Reality for Pain Management in Burn Patients
A study testing Virtual Reality in people with Pain, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosis of a cognitive disorder, psychotic disorder or bipolar I as determined by self-report from previous diagnosis
- Current opioid abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Olivia Baryluk, BS, 212-821-0783, olb4002@med.cornell.edu
JoAnn Difede, PhD
About this study
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
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality, Pain Management, Anxiety, Depression
- Medical subject headings
- Pain, Agnosia, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
Immersive and interactive game played through a portable head-mounted display as a distraction mechanism
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | 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. Receives: Other: Virtual Reality |
| Treatment as Usual | No intervention | Standard of care during painful event (such as wound dressing changes or physical therapy sessions). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Peri-procedural: 30 minutes before to two hours after the painful event.
Change in narcotic dose
Dose of narcotics needed peri-procedure
Measured: Peri-procedural: 30 minutes before to two hours after the painful event.
Secondary outcomes (4)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Peri-procedural: 30 minutes before to two hours after the painful event.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start1 Jun 2018
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JoAnn Difede, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685486
- Sponsor's protocol ID
- 1610017629
- Status last verified
- Jun 2026
- First submitted
- 22 Dec 2020
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41942793
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for Pain Management in Burn Patients
- ClinicalTrials.gov ID
- NCT04685486
- Acronym / sponsor ID
- 1610017629
- Conditions
- Pain
- Keywords
- Virtual Reality, Pain Management, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Other: Virtual RealityVirtual 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. |
| Treatment as Usual | No intervention | –Standard of care during painful event (such as wound dressing changes or physical therapy sessions). |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnosis of a cognitive disorder, psychotic disorder or bipolar I as determined by self-report from previous diagnosis
- Current opioid abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityImmersive and interactive game played through a portable head-mounted display as a distraction mechanism | Other | Virtual Reality |
Primary outcome
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.
Change in narcotic dose
Time frame: Peri-procedural: 30 minutes before to two hours after the painful event.
Dose of narcotics needed peri-procedure
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Derived from this study: PubMed 41942793Emrich 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.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
JoAnn Difede, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Pain, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivia Baryluk, BS (212-821-0783, olb4002@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain (time frame: Peri-procedural: 30 minutes before to two hours after the painful event.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04685486, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.