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Effect of Virtual Reality Technology for Pain Management of Vaso-Occlusive Crisis in Patients With Sickle Cell Disease

RecruitingNAAges 6 Years - 25 YearsAllSt. Jude Children's Research Hospital
NCT03353584 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Acute vaso-occlusive crisis (VOC) is the most common complication in patients with sickle cell disease (SCD) and pain related to VOC is often inadequately treated. This is a phase II randomized controlled clinical trial evaluating the efficacy of virtual reality technology when added to standard pain management for patients with sickle cell disease who are experiencing acute pain crisis in the ambulatory care setting. Patients will be randomized to receive either standard management only or standard management in addition to virtual reality therapy. The remainder of care for the painful event will continue per institutional standards according to clinical indication, including reassessment and documentation of pain and additional doses of pain medicines by intravenous (IV) or oral route. Pain scores and opioid requirement will be measured and compared across treatment arms, along with th

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📋 Eligibility rules (as published)
Inclusion Criteria: * Participant must have sickle cell disease (any genotype), documented in the St. Jude medical record. * Participant must be seeking care for acute VOC pain at St. Jude Children's Research Hospital. * Participant age must be ≥ 6 years and ≤ 25 years. * English speaking Exclusion Criteria: * Prior randomization in this study. * Patients are currently enrolled on another pain management interventional trial for the presenting pain crisis. * Mild pain (score \<4), or pain for which treatment with opioid is not indicated. * Pain in combination with other clinical symptoms that require additional interventions, including fever with focus, acute chest syndrome, acute injury, or splenic sequestration. * Developmental or psychiatric disorders like autism, claustrophobia or other disabilities like vision and hearing defects etc. that preclude the use of a head mounted device. * Inability or unwillingness of research participant or legal guardian/ representative to give written informed consent.
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What it tests

  • Virtual Reality Therapy
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Where

2 sites
Methodist Comprehensive Sickle Cell Center
Memphis, United States
St. Jude Children's Research Hospital
Memphis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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