Recruiting

Virtual Reality

Sponsor:

University of Maryland, Baltimore

Code:

NCT06184126

Conditions

Sickle Cell Disease

Vaso-occlusive Pain Episode in Sickle Cell Disease

Acute Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Virtual Reality Headset and Hand-Held Controllers

Blindfolding and Noise Cancelling

Study Details

Brief summary:

This study aims to evaluate the use of virtual reality as an adjunct to standard care for patients with sickle cell disease experiencing vaso-occlusive crises.

Conditions

Sickle Cell Disease

Vaso-occlusive Pain Episode in Sickle Cell Disease

Acute Pain

Study ID

NCT06184126

Start date

Nov 1, 2024

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult (age > 18 years) emergency department patient
  • History of sickle cell disease
  • Presenting to the emergency department due to acute pain related to sickle cell disease thought to be due to vaso-occlusive crisis

Exclusion Criteria:

  • Prior enrollment in this study
  • Presenting with a chief complaint suggestive of a complicated crisis (such as concern for acute chest syndrome, splenic sequestration, hepatic sequestration, pulmonary embolism) as determined by the clinical care provider
  • Not being treated with intravenous opioids for the vaso-occlusive crisis
  • Patients who lack the capacity to provide informed consent
  • Medical history of seizures or known intolerance to virtual reality
  • Disabilities like vision and hearing defects etc. that preclude the use of a head mounted virtual reality device.
  • Known to be pregnant
  • Incarcerated at the time of evaluation
  • Over the age of 89 years old

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active Immersive Virtual Reality

Patient with sickle cell disease experiencing acute vaso-occlusive crisis randomized to this arm will participate in an active immersive application on the virtual reality headset with hand-held controllers. The active immersive application will allow the user to interact directly with the application and move through the virtual environment .The patient will be able to use the active immersive application on the device for a maximum of two hours.

experimental: Passive Immersive Virtual Reality

Patient with sickle cell disease experiencing acute vaso-occlusive crisis randomized to this arm will participate in a passive immersive application on the virtual reality headset with hand-held controllers. The passive immersive application will not allow the user to interact directly with the application or move through the virtual environment .The patient will be able to use the passive immersive application on the device for a maximum of two hours.

placebo comparator: Blindfold and Ear Plugs

Patient with sickle cell disease experiencing acute vaso-occlusive crisis randomized to this arm will wear a blindfold and ear plugs. The patient will be able to remain blindfolded and earplugs for a maximum of two hours.

Interventions

Virtual Reality Headset and Hand-Held Controllers

Study Group-Virtual reality headset and hand-held controllers will be used as an adjuvant to pain management care.

Blindfolding and Noise Cancelling

Control group-Blindfold and noise cancelling headphones will be a placebo comparator group to the experimental interventions of virtual reality devices.

Primary outcome measure

  • Comparison of the change in pain scores between the 3 groups at one hour after completion of the study intervention. [ Time Frame: A single time point 1 hour after the study intervention ends. ]

Central Contacts and Locations

Central contacts

R. Gentry Wilkerson, MD

410-328-4237gwilkerson@som.umaryland.edu

Locations

University of Maryland Medical Systems

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

R. Gentry Wilkerson, MD

410-328-4237gwilkerson@som.umaryland.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2025-12-24.