| NCT ID | NCT07674277 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Maryland, Baltimore |
| Condition | Sickle Cell Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-11-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-11-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Richard G Wilkerson, MD
PRINCIPAL INVESTIGATOR
Unversity of Maryland School of Medicine
Frequently Asked Questions
Who can join the NCT07674277 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 88 Years, studying Sickle Cell Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07674277 currently recruiting?
Yes, NCT07674277 is actively recruiting participants. Contact the research team at Soowon.Lee@som.umaryland.edu for enrollment information.
Where is the NCT07674277 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT07674277 clinical trial?
NCT07674277 is sponsored by University of Maryland, Baltimore. The principal investigator is Richard G Wilkerson, MD at Unversity of Maryland School of Medicine. The trial plans to enroll 50 participants.
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