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Virtual Reality for SCD VOC

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 88 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "Vaso-occlusive crisis (VOC) is a common and debilitating complication of sickle cell disease (SCD) and is a frequent reason for treatment in acute care settings, including infusion centers and emergency departments."
  • "This study is designed to evaluate the feasibility, tolerability, and preliminary analgesic effect of headset-based visual and audio interventions during infusion center treatment of VOC."
  • "Following enrollment, participants will be eligible to receive study interventions during qualifying infusion center visits for vaso-occlusive pain occurring within six months of enrollment."
  • "Each participant will be randomized to receive two of three headset-based intervention conditions across two separate qualifying infusion center visits."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests whether virtual reality headsets are practical to use, comfortable, and helpful for pain relief. It is for adults with sickle cell disease who have pain crises, when sickle cells block blood flow, and get care at an infusion center. Each person will try two of three headset options at separate visits: a 2D display, 3D virtual reality to watch, or interactive 3D virtual reality.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have sickle cell disease.
  • Have a care plan that includes opioid pain medicine given through a vein for sudden pain.
  • Get treatment at the Stoler Infusion Center.

Who can't join

  • Have already enrolled in this study.
  • Have symptoms that your care provider thinks may mean a complicated crisis, such as serious chest problems, blood trapped in the spleen or liver, or a blood clot in the lungs.
  • Are not getting opioid pain medicine through a vein for the pain crisis.
  • Cannot understand and give consent to join the study.
  • Have a history of seizures or known trouble tolerating virtual reality devices.
  • Have an existing disability, such as vision or hearing problems, that the study doctor believes prevents headset use.
  • Are known to be pregnant.
  • Are in jail or prison when checked for the study, or are older than 89.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

MD