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Tests virtual reality headsets for pain crises in adults with sickle cell disease

Compares virtual reality headsets with a sham headset during sickle cell pain crises in adults.

Plain-language title generated from the registry record
Registry title: Virtual Reality for SCD VOC

Key facts

Where
Baltimore, United StatesSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 88 years old?

Source: NCT07674277, who can take part

Where in United States

  • University of Maryland Medical Center, Stoler Infusion CenterBaltimore, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
University of Maryland, Baltimore
Trial code
NCT07674277
Record updated
16 October 2026
Original description
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.Read full original descriptionShow less

Randomized EvaLuation of ImmErsive Virtual Experiences in Sickle Cell Disease (RELIEVE-SCD)

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.

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.

ClinicalTrials.gov NCT07674277