An interventional study of Virtual Reality Therapy in Sickle Cell Disease and Vaso-occlusive Crisis, sponsored by St. Jude Children's Research Hospital. Recruiting at 2 sites in United States. Open to participants aged 6 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by St. Jude Children's Research Hospital · Not applicable, Interventional, and Supportive care
Among 60 studies in Vaso-Occlusive Crises with a site in United States — 13 open to participants now, 15 under way, 5 of them phase 3. Vaso-Occlusive Crises · United States.
Among the 60 studies in Vaso-Occlusive Crises with a site in United States, this one is the 24th largest by planned enrollment of the 56 interventional ones, is one of 4 that started in 2018, is one of 9 with no phase, reaches primary completion later than 4 of the 14 other live ones, and was the 28th registered.
104 studies on the registry are indexed under Vaso-Occlusive Crises; 31 are open to participants now.
This study's planned enrollment of 76 is close to the median of 81 across 86 interventional studies indexed under Vaso-Occlusive Crises.
Browse Vaso-Occlusive Crises studies →13 of the 60 studies in Vaso-Occlusive Crises with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 17 Vaso-Occlusive Crises studies recruiting now, 7 (41%) set no upper age limit and 6 (35%) stop at 75 or younger; 10 take children under 18; 1 take healthy volunteers.
This study: 6 Years to 25 Years · all sexes · no healthy volunteers.
The full table on the hub →60 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 4 started in 2018.
Median enrollment 63 across the 56 interventional studies, 82 across the 4 observational. Of the 41 that completed or were terminated, 21 (51%) have results posted.
25 of 60 have an industry lead sponsor. The 10 most frequent:
St. Jude Children's Research Hospital is the lead sponsor of 440 studies on the registry; 102 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 37 (61%) have results posted.
St. Jude Children's Research Hospital has 2 studies filed under Vaso-Occlusive Crises — fewer than ten, so there is no comparison to draw.
3 of the studies in Vaso-Occlusive Crises with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06989567Phase 3Asklepion Pharmaceuticals, LLCA Study of Intravenous L-Citrulline in Patients Aged 6-21 Years Old With Sickle Cell Disease Presenting to Emergency Departments in Acute Vaso-Occlusive Crisis | 2027-06 |
| NCT03353584St. Jude Children's Research HospitalEffect of Virtual Reality Technology for Pain Management of Vaso-Occlusive Crisis in Patients With Sickle Cell Disease | 2026-11 |
| NCT06699849CSL BehringSafety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis | 2027-10-22 |
Among the 60 studies in Vaso-Occlusive Crises with a site in United States, from their registry updates:
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:
After consenting to participate in this study, patients will be randomized to receive either standard care therapy for VOC or to receive standard care therapy plus a 15-minute virtual reality (VR) session. They will be additionally randomized into strata by age: 6 to 11 years, 12 to 18 years, and 19 to 25 years. At the end of therapy or therapy plus the VR session, they will be asked to complete a 5-minute satisfaction survey. Information will also be collected from the medical record about the pain episode, including pain scores, medicines used, and time needed for pain to lessen.
Standard care for management of an acute VOC includes parenteral hydration and pain management with non-steroidal anti-inflammatory agents, such as Toradol or Ibuprofen, and opioids. Pain scores will be measured at three different time points: baseline at presentation, at 30±10 minutes after first intravenous (IV) analgesic medication, and at 60±10 minutes after first IV analgesic medication.
Use of VR will be included in addition to the standard care for management of patients randomized to VR arm. VR is an interactive technology that allows the user to interface with a three dimensional computer-generated environment by means of a lightweight head mounted display. The user is transported into a relaxing VR environment that diverts their attention away from pain. The duration of VR session is 15 minutes. Pain scores will be measured at three different time points: baseline at presentation, at 15±10 minutes after completion of VR therapy, and at 60±10 minutes after completion of VR therapy.
104 studies on the registry are indexed under Vaso-Occlusive Crises; 31 are open to participants now.
This study's planned enrollment of 76 is close to the median of 81 across 86 interventional studies indexed under Vaso-Occlusive Crises.
Browse Vaso-Occlusive Crises studies →St. Jude Children's Research Hospital is the lead sponsor of 440 studies on the registry; 102 are open to participants now.
Of its 61 completed or terminated interventional studies of FDA-regulated products, 37 (61%) have results posted.
Compared within Vaso-Occlusive Crises, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anemia, Sickle Cell. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive standard care treatment for their vaso-occlusive crisis. Participants will be randomized by age.
Participants receive standard care treatment for their vaso-occlusive crisis. In addition, they will have a 15-minute Virtual Reality Therapy session. Participants will be randomized by age.
Other: Virtual Reality Therapy
The VR intervention consists of an interactive audio and visual underwater experience designed to serve as a calming distraction activity. The VR software (Kind VR® Aqua) was developed by KindVR specifically for the purpose of pain distraction in a hospital setting.
Also known as: VR therapy
Change in pain scores
The highest pain score based on all scores at different body pain locations is used as the pain score. The changes in pain scores in two arms between baseline and 30 minutes post study intervention will be summarized and compared using Wilcoxon rank sum test at a significance level of 0.1.
Time frame: Baseline and up to 30 minutes after intervention
Not enrolling at this site.
Started Feb 2018 (actual). Primary completion is estimated for Nov 2026, 105 months after the start.
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St. Jude Children's Research Hospital →