Virtual reality options to help with VOC pain in adults with SCD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized pilot study will compare three headset-based interventions—sham 2D, passive immersive 3D, and active interactive 3D VR—as an adjunct to usual care for adults with sickle cell disease experiencing VOC in an infusion center. Each participant receives two of the three interventions in a two-period crossover design during separate VOC treatment visits, with each session lasting 45 minutes. The study aims to assess feasibility, tolerability, and preliminary analgesic effects in up to 50 participants. Enrollment occurs when patients are clinically stable for outpatient screening, with randomization conducted during qualifying VOC visits. The approach explores non-pharmacologic pain management to potentially complement opioid therapy for VOC.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Maryland Medical Center, Stoler Infusion Center
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Richard G Wilkerson, MD — Unversity of Maryland School of Medicine
• Study coordinator: Soowon Lee, MSPH
• Email: Soowon.Lee@som.umaryland.edu
• Phone: 254-400-4894

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.