Virtual Reality for SCD VOC

Study acronym: RELIEVE-SCD
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 3 months later Aug 2027 → Dec 2027
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Record History

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  1. Notable Recruitment opened Show 9 more changesShow less
    • Enrollment increased: 25 → 50 participants
    • Start date: Aug 1, 2026 to Nov 1, 2026
    • Primary completion pushed from Aug 2027 to Dec 2027
    • Study completion pushed from Dec 2027 to Mar 2028
    • Eligibility criteria expanded, about 56 words
    • Secondary endpoints: details revised at 5 of 8 entries
    • Study description expanded, about 96 words
    • Site details revised
    • Publications: details revised at 9 of 9 entries
  2. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07674277
Lead Sponsor University of Maryland, Baltimore
Conditions
(from sponsor)
Sickle Cell Disease
Related terms Anemia, Sickle Cell, Vaso-Occlusive Crises
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov