Virtual Reality for SCD VOC (RELIEVE-SCD)
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Details and patient eligibility
About
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.
Full description
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. 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 (VR) is a promising non-pharmacologic approach to pain management that may reduce pain through immersive distraction, modulation of attention, and enhanced patient engagement. Prior studies suggest that VR may reduce acute and chronic pain in some clinical settings, but its effect may vary by population and condition. Limited data are available regarding the use of VR for acute vaso-occlusive pain in adults with SCD. 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.
This is a randomized, controlled, two-period crossover pilot study using a balanced incomplete block design. Up to 50 participants will be enrolled during routine outpatient sickle cell disease clinic visits when they are clinically stable and not experiencing an acute VOC. Written informed consent and randomization will occur during these outpatient visits and will not occur during an acute VOC infusion center encounter. 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. At each qualifying visit, study staff will confirm continued eligibility, clinical appropriateness, and the participant's willingness to proceed before delivering the assigned intervention.
Each participant will be randomized to receive two of three headset-based intervention conditions across two separate qualifying infusion center visits. The three conditions are:
- **Sham 2D headset control:** Non-interactive two-dimensional nature-related video content displayed on a fixed virtual screen with standardized audio.
- **Passive immersive 3D VR:** Immersive three-dimensional visual content delivered using the Nature Treks application with standardized audio, allowing participants to look around the virtual environment without controller-based interaction.
- **Active immersive interactive 3D VR:** Immersive interactive content delivered using the Nature Treks application with standardized audio, allowing participants to interact with the virtual environment using controllers while completing low-motion, seated activities.
All three intervention conditions will be delivered using the Meta Quest 2 headset platform. Each intervention session is planned to last 45 minutes and will be provided as an adjunct to usual clinical care for VOC. Participation will not alter clinical management, including opioid administration, rescue analgesia, fluid administration, monitoring, or disposition decisions.
Randomization will assign each participant to one of three possible intervention pairs: sham 2D plus passive immersive 3D VR, sham 2D plus active immersive interactive 3D VR, or passive immersive 3D VR plus active immersive interactive 3D VR. Within each pair, the order of interventions will be randomized to balance period and sequence effects, resulting in six possible intervention sequences. Participants and study staff will not be blinded to the intervention condition because the interventions are perceptible; however, the use of a headset-based control condition and standardized scripts is intended to reduce differences in attention and expectancy across conditions.
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. Pain scores will be collected before intervention and at 15, 30, 45, and 60 minutes after intervention start. Secondary and exploratory outcomes include pain at approximately 120 minutes, change in pain from baseline to 120 minutes, opioid administration summarized as morphine milligram equivalents, need for rescue analgesia, feasibility of intervention delivery, session completion, missing pain assessments, early discontinuation, headset-related adverse symptoms, perceived immersion, and participant-reported likelihood of using the intervention again during future VOC treatment.
The study will enroll a convenience sample of up to 50 participants based on the expected eligible infusion center population. Each participant may complete up to two intervention sessions during separate qualifying infusion center visits within six months of enrollment. The primary purpose of this pilot study is to estimate feasibility, tolerability, preliminary treatment effects, and variability to inform the design of a future larger efficacy trial.
Enrollment
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Volunteers
Inclusion and exclusion 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
50 participants in 6 patient groups
Trial contacts and locations
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Central trial contact
Rose Corcoran; Soowon Lee, MSPH
Data sourced from clinicaltrials.gov
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