About this trial
This pilot study will evaluate the feasibility, tolerability, and preliminary analgesic effect of headset-based virtual reality interventions for adults with sickle cell disease experiencing vaso-occlusive crisis treated in an infusion center. Participants will be enrolled during routine outpatient sickle cell clinic visits and may receive study interventions during future qualifying infusion center visits for vaso-occlusive pain. Using a randomized, two-period crossover design, each participant will be assigned to receive two of three headset-based conditions across separate visits: sham 2D headset control, passive immersive 3D virtual reality, or active immersive interactive 3D virtual reality. The primary outcome is pain burden during the first 60 minutes after intervention start, measured as 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 use, and participant-reported immersion and acceptability.
Eligibility criteria
Qualifiers
Adult (age ≥ 18 years) patients
History of sickle cell disease
Treatment plan by clinical care team includes the use of intravenous opioids to -treat acute pain.
Receiving treatment from the Stoler Infusion center
Disqualifiers
Prior enrollment in this study
Presenting with a chief complaint suggestive of a complicated crisis (such as concern for acute chest syndrome, splenic sequestration, hepatic sequestration, pulmonary embolism) as determined by the clinical care provider
Not being treated with intravenous opioids for the vaso-occlusive crisis
Patients who lack the capacity to provide informed consent
Trial design
Treatments tested in this trial
- Sham 2D Headset Control
- Passive Immersive 3D Virtual Reality
- Active Immersive Interactive 3D Virtual Reality
Treatment groups
6
Treatment groupsSee each treatment group below.