Virtual Reality for Sickle Cell Crisis
(RELIEVE-SCD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether virtual reality (VR) headsets can reduce pain for adults with sickle cell disease during vaso-occlusive crises. Participants will experience various VR sessions, such as 3D immersive and interactive activities, to determine which most effectively eases pain. The study aims to evaluate how well these VR sessions complement standard pain treatments, like intravenous opioids. Individuals with sickle cell disease who receive opioid treatment for pain and visit the Stoler Infusion Center may qualify for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques that could enhance quality of life.
What prior data suggests that this virtual reality intervention is safe for adults with sickle cell disease?
Research has shown that virtual reality (VR) treatments are generally safe for people with sickle cell disease. One study found that 15-minute VR sessions were manageable and did not cause major side effects. Both active and passive types of 3D VR treatments are well-tolerated.
Other studies have found that VR therapy is practical and helps reduce pain during sickle cell pain episodes, which occur when blood flow is blocked. Participants typically had a positive experience with VR and did not report significant negative effects.
Overall, while more research is needed, current studies suggest that using VR to manage pain during sickle cell crises is safe and well-tolerated.12345Why are researchers excited about this trial?
Researchers are excited about using virtual reality (VR) to manage sickle cell crises because it offers a non-drug approach to pain relief, which is different from the usual reliance on medications like opioids. The unique aspect of this trial is testing both passive and active immersive 3D VR experiences. Passive VR allows participants to be immersed in a 360-degree environment without interaction, while active VR adds an interactive element, engaging users more deeply. This innovative approach could provide a much-needed alternative that reduces pain without side effects, while also offering a more engaging and potentially effective distraction during painful episodes.
What evidence suggests that this trial's virtual reality interventions could be effective for sickle cell crisis?
Research has shown that virtual reality (VR) can help manage pain for people with sickle cell disease during painful episodes known as vaso-occlusive crises. In this trial, participants will experience different VR conditions. Studies have found that both active and passive 3D VR sessions effectively reduce pain. Specifically, one study reported a noticeable drop in pain levels, highlighting VR's potential as an additional pain treatment. This method uses engaging sights and sounds to distract patients from their pain. Early results suggest that VR may provide relief and improve the pain experience during these crises.12456
Who Is on the Research Team?
Richard G Wilkerson, MD
Principal Investigator
Unversity of Maryland School of Medicine
Are You a Good Fit for This Trial?
This trial is for adults with sickle cell disease who are experiencing a pain crisis and are being treated at an infusion center. Participants must be able to use a headset device during their visit.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive two of three headset-based VR interventions during separate qualifying infusion center visits for vaso-occlusive pain.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pain assessments and opioid consumption.
What Are the Treatments Tested in This Trial?
Interventions
- Active Immersive Interactive 3D Virtual Reality
- Passive Immersive 3D Virtual Reality
Trial Overview
The study tests three types of headset experiences: a basic (sham) 2D video, passive immersive 3D virtual reality, and active interactive 3D virtual reality. Each participant tries two different options in random order across separate visits.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
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.
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.
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor
Citations
Virtual Reality for SCD VOC - ClinicalTrials.Veeva
This pilot study will evaluate the feasibility, tolerability, and preliminary analgesic effect of headset-based virtual reality ...
Virtual Reality Devices as an Adjunct to Usual Care for ...
Patient with sickle cell disease experiencing acute vaso-occlusive crisis randomized to this arm will participate in an active immersive application on the ...
Virtual Reality for SCD VOC
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 ...
Preliminary Benefits of In-Home Virtual Reality for Chronic ...
Results: Average intervention use was 19.1 and 12.1 min per day in VR and audio, respectively. Preliminary benefits of VR included decreased pain (p = 0.002), ...
Effect of Virtual Reality Technology for Pain Management ...
Effect of Virtual Reality Technology for Pain Management of Vaso-Occlusive Crisis in Patients With Sickle Cell Disease. Last updated: May 13 ...
Virtual Reality Therapy for Sickle Cell Crisis
The VR sessions, typically lasting about 15 minutes, were manageable and did not cause major side effects.
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