NCT03353584Recruiting
Effect of Virtual Reality Technology for Pain Management of Vaso-Occlusive Crisis in Patients With Sickle Cell Disease
Pain Management of Vaso-Occlusive Crisis in Children and Young Adults With Sickle Cell Disease-Effect of Virtual Reality Technology
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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 the outcomes of discharge from clinic versus admission to the inpatient unit. PRIMARY OBJECTIVE: To assess the efficacy of virtual reality (VR) technology in reducing pain at 30 minutes after intervention during an acute vaso-occlusive crisis in patients with sickle cell disease. Primary endpoint will be change in pain scores in Standard versus VR arms, between the first pain assessment at the time of presentation and the subsequent pain assessments up to 30 minutes after intervention. Secondary Objectives: * To compare total opioid consumption from the time of presentation to the time of discharge from acute care setting in Standard versus VR arms. * To assess the efficacy of virtual reality (VR) technology in reducing pain at 60 minutes after the first IV medication administered or 60 minutes after completion VR during an acute vaso-occlusive crisis in patients with sickle cell disease.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- First submitted
- 21 Nov 2017
- Start date
- 5 Feb 2018
- Primary completion date
- Nov 2026
- Lead sponsor
- St. Jude Children's Research Hospital
- Diseases
- Sickle cell disease
- NCT number
- NCT03353584
What you commit to
- Study type: Interventional
- Planned participants: 76
- From 5 Feb 2018 to the primary completion date, Nov 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior randomization in this study.
- Mild pain (score \<4), or pain for which treatment with opioid is not indicated.
Other illness
- 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.
Other
- Patients are currently enrolled on another pain management interventional trial for the presenting pain crisis.
- Inability or unwillingness of research participant or legal guardian/ representative to give written informed consent.
Who the study is looking for
- 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
Age in the registry: 6 years to 25 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Methodist Comprehensive Sickle Cell Center Coordinator of this site? Confirm its status | Memphis | United States | Completed |
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.