Randomized EvaLuation of ImmErsive Virtual Experiences in Sickle Cell Disease (RELIEVE-SCD)
University of Maryland, Baltimore
Summary
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.
Description
Vaso-occlusive crisis is a common and debilitating complication of sickle cell disease and is a frequent reason for treatment in acute care settings, including infusion centers and emergency departments. Opioid analgesics remain the mainstay of treatment for acute vaso-occlusive pain, but many patients continue to experience substantial pain, distress, and functional impairment despite standard therapy. Scalable, low-risk, non-pharmacologic adjuncts are needed to improve pain management during acute vaso-occlusive episodes. Virtual reality is a promising non-pharmacologic approach to pain man…
Eligibility
- Age range
- 18–89 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * P…
Interventions
- DeviceSham 2D Headset Control
The sham 2D headset control condition consists of non-interactive two-dimensional visual content displayed on a fixed virtual screen using the Meta Quest headset platform. Standardized audio will be provided during the session. Participants will wear the headset for a planned 45-minute session during a qualifying vaso-occlusive crisis infusion center visit. This condition is intended to serve as a headset-based control while maintaining similar attention and device exposure across study conditions.
- DevicePassive Immersive 3D Virtual Reality
The passive immersive 3D virtual reality condition consists of 360-degree or three-dimensional immersive visual content delivered using the Meta Quest headset platform with standardized audio. Participants may look around within the virtual environment but will not interact with the content using controllers. Participants will wear the headset for a planned 45-minute session during a qualifying vaso-occlusive crisis infusion center visit.
- DeviceActive Immersive Interactive 3D Virtual Reality
The active immersive interactive 3D virtual reality condition consists of immersive interactive virtual reality content delivered using the Meta Quest headset platform with standardized audio. Participants will interact with the virtual environment using controllers while completing low-motion, seated modules. Participants will wear the headset for a planned 45-minute session during a qualifying vaso-occlusive crisis infusion center visit.
Location
- University of Maryland Medical Center, Stoler Infusion CenterBaltimore, Maryland