Randomized EvaLuation of ImmErsive Virtual Experiences in Sickle Cell Disease (RELIEVE-SCD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Pain burden during the first 60 minutes after intervention start
Study Overview
Brief 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.
Detailed 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 management that may reduce pain through immersive distraction, modulation of attention, and enhanced patient engagement. Prior studies suggest that virtual reality may reduce acute and chronic pain in some clinical settings, but the effect may vary by population and condition. Limited data are available regarding the use of virtual reality for acute vaso-occlusive pain in adults with sickle cell disease. 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 vaso-occlusive crisis.
This is a randomized, controlled, two-period crossover pilot study using a balanced incomplete block design. Participants will be enrolled during routine outpatient sickle cell disease clinic visits when they are clinically stable and not experiencing an acute vaso-occlusive crisis. After enrollment, participants will be eligible to receive study interventions during future qualifying infusion center visits for vaso-occlusive pain occurring within the study follow-up window. At each qualifying visit, study staff will confirm continued eligibility, medical 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, consisting of non-interactive 2D visual content displayed on a fixed virtual screen with standardized audio; passive immersive 3D virtual reality, consisting of 360-degree or 3D immersive visual content with standardized audio without controller-based interaction; and active immersive interactive 3D virtual reality, consisting of immersive interactive virtual reality content with standardized audio and low-motion, seated controller-based interaction. Each intervention session is planned to last 45 minutes and will be delivered in addition to usual clinical care for vaso-occlusive crisis.
Randomization will assign each participant to one of three possible intervention pairs: sham 2D plus passive 3D virtual reality, sham 2D plus active interactive 3D virtual reality, or passive 3D virtual reality plus active interactive 3D virtual reality. Within each pair, the order of interventions will be randomized to balance period and sequence effects. Participants and study staff will not be blinded to the intervention condition because the interventions are perceptible; however, use of a headset-based control condition and standardized scripts is intended to reduce differences in attention and expectancy across conditions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •Patients who lack the capacity to provide informed consent
- •Medical history of seizures or known intolerance to virtual reality devices
- •In the opinion of the investigator and based on chart review and direct questioning of the patient, there are preexisting disabilities like vision and hearing defects that preclude the use of a head mounted virtual reality device.
- •Known to be pregnant
- •Incarcerated at the time of evaluation
- •Over the age of 89 years old
Arms & Interventions
Active 3D VR → Passive 3D VR
Participants randomized to this sequence will receive the active immersive interactive 3D virtual reality condition during the first qualifying vaso-occlusive crisis infusion center visit and the passive immersive 3D virtual reality condition during the second qualifying vaso-occlusive crisis infusion center visit. The active immersive interactive 3D virtual reality condition consists of immersive interactive virtual reality content with standardized audio, using low-motion, seated modules with controller-based interaction. The passive immersive 3D virtual reality condition consists of 360-degree or 3D immersive visual content with standardized audio, allowing participants to look around without controller-based interaction.
Intervention: Passive Immersive 3D Virtual Reality (Device)
Active 3D VR → Passive 3D VR
Participants randomized to this sequence will receive the active immersive interactive 3D virtual reality condition during the first qualifying vaso-occlusive crisis infusion center visit and the passive immersive 3D virtual reality condition during the second qualifying vaso-occlusive crisis infusion center visit. The active immersive interactive 3D virtual reality condition consists of immersive interactive virtual reality content with standardized audio, using low-motion, seated modules with controller-based interaction. The passive immersive 3D virtual reality condition consists of 360-degree or 3D immersive visual content with standardized audio, allowing participants to look around without controller-based interaction.
Intervention: Active Immersive Interactive 3D Virtual Reality (Device)
Sham 2D, then Passive 3D VR
Participants randomized to this sequence will receive the sham 2D headset control condition during the first qualifying vaso-occlusive crisis infusion center visit and the passive immersive 3D virtual reality condition during the second qualifying vaso-occlusive crisis infusion center visit. The sham 2D condition consists of non-interactive 2D visual content displayed on a fixed virtual screen with standardized audio. The passive immersive 3D virtual reality condition consists of 360-degree or 3D immersive visual content with standardized audio, allowing participants to look around without controller-based interaction.
Intervention: Sham 2D Headset Control (Device)
Sham 2D, then Passive 3D VR
Participants randomized to this sequence will receive the sham 2D headset control condition during the first qualifying vaso-occlusive crisis infusion center visit and the passive immersive 3D virtual reality condition during the second qualifying vaso-occlusive crisis infusion center visit. The sham 2D condition consists of non-interactive 2D visual content displayed on a fixed virtual screen with standardized audio. The passive immersive 3D virtual reality condition consists of 360-degree or 3D immersive visual content with standardized audio, allowing participants to look around without controller-based interaction.
Intervention: Passive Immersive 3D Virtual Reality (Device)
Passive 3D VR → Sham 2D
Participants randomized to this sequence will receive the passive immersive 3D virtual reality condition during the first qualifying vaso-occlusive crisis infusion center visit and the sham 2D headset control condition during the second qualifying vaso-occlusive crisis infusion center visit. The passive immersive 3D virtual reality condition consists of 360-degree or 3D immersive visual content with standardized audio, allowing participants to look around without controller-based interaction. The sham 2D condition consists of non-interactive 2D visual content displayed on a fixed virtual screen with standardized audio.
Intervention: Sham 2D Headset Control (Device)
Passive 3D VR → Sham 2D
Participants randomized to this sequence will receive the passive immersive 3D virtual reality condition during the first qualifying vaso-occlusive crisis infusion center visit and the sham 2D headset control condition during the second qualifying vaso-occlusive crisis infusion center visit. The passive immersive 3D virtual reality condition consists of 360-degree or 3D immersive visual content with standardized audio, allowing participants to look around without controller-based interaction. The sham 2D condition consists of non-interactive 2D visual content displayed on a fixed virtual screen with standardized audio.
Intervention: Passive Immersive 3D Virtual Reality (Device)
Sham 2D → Active 3D VR
Participants randomized to this sequence will receive the sham 2D headset control condition during the first qualifying vaso-occlusive crisis infusion center visit and the active immersive interactive 3D virtual reality condition during the second qualifying vaso-occlusive crisis infusion center visit. The sham 2D condition consists of non-interactive 2D visual content displayed on a fixed virtual screen with standardized audio. The active immersive interactive 3D virtual reality condition consists of immersive interactive virtual reality content with standardized audio, using low-motion, seated modules with controller-based interaction.
Intervention: Sham 2D Headset Control (Device)
Sham 2D → Active 3D VR
Participants randomized to this sequence will receive the sham 2D headset control condition during the first qualifying vaso-occlusive crisis infusion center visit and the active immersive interactive 3D virtual reality condition during the second qualifying vaso-occlusive crisis infusion center visit. The sham 2D condition consists of non-interactive 2D visual content displayed on a fixed virtual screen with standardized audio. The active immersive interactive 3D virtual reality condition consists of immersive interactive virtual reality content with standardized audio, using low-motion, seated modules with controller-based interaction.
Intervention: Active Immersive Interactive 3D Virtual Reality (Device)
Active 3D VR → Sham 2D
Participants randomized to this sequence will receive the active immersive interactive 3D virtual reality condition during the first qualifying vaso-occlusive crisis infusion center visit and the sham 2D headset control condition during the second qualifying vaso-occlusive crisis infusion center visit. The active immersive interactive 3D virtual reality condition consists of immersive interactive virtual reality content with standardized audio, using low-motion, seated modules with controller-based interaction. The sham 2D condition consists of non-interactive 2D visual content displayed on a fixed virtual screen with standardized audio.
Intervention: Sham 2D Headset Control (Device)
Active 3D VR → Sham 2D
Participants randomized to this sequence will receive the active immersive interactive 3D virtual reality condition during the first qualifying vaso-occlusive crisis infusion center visit and the sham 2D headset control condition during the second qualifying vaso-occlusive crisis infusion center visit. The active immersive interactive 3D virtual reality condition consists of immersive interactive virtual reality content with standardized audio, using low-motion, seated modules with controller-based interaction. The sham 2D condition consists of non-interactive 2D visual content displayed on a fixed virtual screen with standardized audio.
Intervention: Active Immersive Interactive 3D Virtual Reality (Device)
Passive 3D VR → Active 3D VR
Participants randomized to this sequence will receive the passive immersive 3D virtual reality condition during the first qualifying vaso-occlusive crisis infusion center visit and the active immersive interactive 3D virtual reality condition during the second qualifying vaso-occlusive crisis infusion center visit. The passive immersive 3D virtual reality condition consists of 360-degree or 3D immersive visual content with standardized audio, allowing participants to look around without controller-based interaction. The active immersive interactive 3D virtual reality condition consists of immersive interactive virtual reality content with standardized audio, using low-motion, seated modules with controller-based interaction.
Intervention: Passive Immersive 3D Virtual Reality (Device)
Passive 3D VR → Active 3D VR
Participants randomized to this sequence will receive the passive immersive 3D virtual reality condition during the first qualifying vaso-occlusive crisis infusion center visit and the active immersive interactive 3D virtual reality condition during the second qualifying vaso-occlusive crisis infusion center visit. The passive immersive 3D virtual reality condition consists of 360-degree or 3D immersive visual content with standardized audio, allowing participants to look around without controller-based interaction. The active immersive interactive 3D virtual reality condition consists of immersive interactive virtual reality content with standardized audio, using low-motion, seated modules with controller-based interaction.
Intervention: Active Immersive Interactive 3D Virtual Reality (Device)
Outcomes
Primary Outcomes
Pain burden during the first 60 minutes after intervention start
Time Frame: 60 minutes ± 10 minutes
Pain burden will be measured as the area under the curve from 0 to 60 minutes of participant-reported pain scores using an 11-point Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst possible pain. Pain scores will be collected at baseline before intervention start and at 15, 30, 45, and 60 minutes after intervention start. Area under the curve will be calculated using the trapezoidal rule with actual recorded assessment times.
Secondary Outcomes
- Pain at 120 minutes after intervention start (Durability of effect)(120 minutes)
- Participant-Reported Immersion Rating Immediately After Headset Session(Immediately after headset session completion or early discontinuation)
- Participant-Reported Likelihood of Future Use Rating Immediately After Headset Session(Immediately after headset session completion or early discontinuation)
- Opioid consumption during the first 60 minutes after intervention start(0 to 60 minutes after intervention start)
- Opioid consumption during the first 120 minutes after intervention start(0 to 120 minutes after intervention start)
- Headset session completion(During the 45-minute headset session)
- Number of Headset Sessions With Any Headset-Related Adverse Symptom(From intervention start through immediately after headset session completion or early discontinuation, up to 45 minutes after intervention start)
- Completion of both assigned intervention periods(From enrollment through 6 months after enrollment)
Investigators
Richard Gentry Wilkerson
Associate Professor, University of Maryland School of Medicine Department of Emergency Medicine Director of Clinical Research, University of Maryland School of Medicine Department of Emergency Medicine Assistant Residency Program Director
University of Maryland, Baltimore