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RECRUITING
NCT07674277
NA

Virtual Reality for SCD VOC

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

Summary

This randomized pilot study will evaluate the feasibility, tolerability, and preliminary analgesic effect of headset-based virtual reality (VR) interventions for adults with sickle cell disease (SCD) experiencing vaso-occlusive crisis (VOC) treated in an infusion center. Up to 50 participants will be enrolled, provide informed consent, and undergo randomization during routine outpatient sickle cell clinic visits when they are clinically stable and not experiencing an acute VOC. Using a randomized, two-period crossover design, each participant will be assigned to receive two of three headset-based interventions during separate qualifying infusion center visits for vaso-occlusive pain occurring within six months of enrollment: sham 2D headset control, passive immersive 3D VR, or active immersive interactive 3D VR. Each intervention will be delivered during a 45-minute session as an adjunct to usual clinical care. The primary outcome is pain burden during the first 60 minutes after intervention start, measured as the area under the curve of 0-10 numeric rating scale pain scores. Secondary outcomes include feasibility of intervention delivery, headset tolerability, pain at 120 minutes, opioid consumption, and participant-reported immersion and acceptability. Findings will inform the design of future trials evaluating VR as an adjunctive treatment for acute vaso-occlusive pain.

Official title: Randomized EvaLuation of ImmErsive Virtual Experiences in Sickle Cell Disease (RELIEVE-SCD)

Key Details

Gender

All

Age Range

18 Years - 88 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-11-01

Completion Date

2028-03

Last Updated

2026-10-16

Healthy Volunteers

No

Interventions

DEVICE

Sham 2D Headset Control

The sham 2D headset control condition consists of non-interactive, two-dimensional nature-related video content displayed on a fixed virtual screen using the Meta Quest 2 headset platform. The content will be presented through the YouTube application and will depict natural environments similar to those used in the immersive VR conditions. Standardized audio will accompany the visual content. Participants will wear the headset for a planned 45-minute session during a qualifying vaso-occlusive crisis infusion center visit. This condition serves as a headset-based control to maintain similar device exposure and attention across intervention conditions while minimizing immersion and interactivity.

DEVICE

Passive Immersive 3D Virtual Reality

The passive immersive 3D virtual reality condition consists of immersive three-dimensional visual content delivered through the Nature Treks application using the Meta Quest 2 headset platform. Participants will experience immersive natural environments with standardized audio and may look around the virtual environment but will not interact with the content using controllers. Participants will wear the headset for a planned 45-minute session during a qualifying vaso-occlusive crisis infusion center visit. The intervention will be provided as an adjunct to usual clinical care.

DEVICE

Active Immersive Interactive 3D Virtual Reality

The active immersive interactive 3D virtual reality condition consists of immersive, interactive three-dimensional content delivered through the Nature Treks application using the Meta Quest 2 headset platform. Participants will experience immersive natural environments with standardized audio and interact with the virtual environment using handheld controllers while completing low-motion, seated activities. Participants will wear the headset for a planned 45-minute session during a qualifying vaso-occlusive crisis infusion center visit. The intervention will be provided as an adjunct to usual clinical care.

Locations (1)

University of Maryland Medical Center, Stoler Infusion Center

Baltimore, Maryland, United States