Virtual Reality Devices as an Adjunct to Usual Care for Patients With Sickle Cell Disease Experiencing Vaso-Occlusive Crises

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06184126
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Virtual Reality Headset and Hand-Held Controllers — DEVICE
    Study Group-Virtual reality headset and hand-held controllers will be used as an adjuvant to pain management care.
  • Blindfolding and Noise Cancelling — OTHER
    Control group-Blindfold and noise cancelling headphones will be a placebo comparator group to the experimental interventions of virtual reality devices.

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Medical SystemsBaltimoreMaryland21201
R. Gentry Wilkerson, MD
[email protected]
410-328-4237

Find similar trials in Baltimore, MD

By condition
Sickle cell disease
By research site
University of Maryland Medical Systems· Baltimore, MD

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