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โ† Trials
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Virtual Reality for SCD VOC

RecruitingNAAges 18 Years - 88 YearsAllUniversity of Maryland, Baltimore
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In plain words

What the trial is, and whether it could suit you

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 adjunc

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Participants will be identified, screened, and consented during routine outpatient sickle cell disease clinic visits when they are clinically stable and not experiencing an acute vaso-occlusive crisis (VOC). Following enrollment, eligibility for each study intervention session will be confirmed during a qualifying VOC visit to the Stoler Infusion Center. Participants must meet the applicable clinical eligibility criteria and be receiving intravenous opioid treatment for acute vaso-occlusive pain at the time of the intervention visit. \*\*Inclusion Criteria:\*\* * Adult patients aged 18 years or older. * History of sickle cell disease. * Treatment plan by the clinical care team includes intravenous opioids for acute pain. * Receiving treatment through the Stoler Infusion Center. \*\*Exclusion Criteria:\*\* * Prior enrollment in this study. * Presentation with a chief complaint suggestive of a complicated vaso-occlusive crisis, including concern for acute chest syndrome, splenic sequestration, hepatic sequestration, or pulmonary embolism, as determined by the treating clinician. * Not receiving intravenous opioids for the vaso-occlusive crisis. * Inability to provide informed consent. * Medical history of seizures or known intolerance to virtual reality devices. * Preexisting visual or hearing impairments that, in the investigator's judgment, preclude use of a head-mounted virtual reality device. * Known pregnancy. * Incarceration at the time of evaluation. * Age greater than 88 years.
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What it tests

  • Sham 2D Headset Control
  • Passive Immersive 3D Virtual Reality
  • Active Immersive Interactive 3D Virtual Reality
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Where

1 site
University of Maryland Medical Center, Stoler Infusion Center
Baltimore, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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