NCT07674277Recruiting
Virtual Reality for SCD VOC
Randomized EvaLuation of ImmErsive Virtual Experiences in Sickle Cell Disease (RELIEVE-SCD)
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 13 Jun 2026
- Start date
- Nov 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- University of Maryland, Baltimore
- Diseases
- Sickle cell disease
- NCT number
- NCT07674277
What you commit to
- Study type: Interventional
- Planned participants: 50
- From Nov 2026 to the primary completion date, Dec 2027
- 1 site 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.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to 88 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Maryland Medical Center, Stoler Infusion Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.