Virtual Reality Therapy for Sickle Cell Crisis
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. It mentions that standard pain management will continue, so it's likely you can keep taking your usual pain medicines.
What data supports the effectiveness of the treatment Virtual Reality Therapy for Sickle Cell Crisis?
Research shows that virtual reality (VR) therapy can help reduce pain by providing an immersive experience that distracts patients from pain. Studies have found VR to be effective in managing pain in various medical settings, including for patients with sickle cell disease, suggesting it could be beneficial for sickle cell crisis pain management.12345
Is virtual reality therapy safe for humans?
How is virtual reality therapy different from other treatments for sickle cell crisis?
Virtual reality therapy is unique because it uses immersive, three-dimensional environments to help manage pain, offering a non-drug alternative that can be used alongside traditional pain medications. This approach is novel for sickle cell crisis as it provides a distraction and potentially reduces the perception of pain without the side effects associated with medications.12789
What is the purpose of this trial?
Acute vaso-occlusive crisis (VOC) is the most common complication in patients with sickle cell disease (SCD) and pain related to VOC is often inadequately treated. This is a phase II randomized controlled clinical trial evaluating the efficacy of virtual reality technology when added to standard pain management for patients with sickle cell disease who are experiencing acute pain crisis in the ambulatory care setting. Patients will be randomized to receive either standard management only or standard management in addition to virtual reality therapy. The remainder of care for the painful event will continue per institutional standards according to clinical indication, including reassessment and documentation of pain and additional doses of pain medicines by intravenous (IV) or oral route. Pain scores and opioid requirement will be measured and compared across treatment arms, along with the outcomes of discharge from clinic versus admission to the inpatient unit.PRIMARY OBJECTIVE: To assess the efficacy of virtual reality (VR) technology in reducing pain at 30 minutes after intervention during an acute vaso-occlusive crisis in patients with sickle cell disease. Primary endpoint will be change in pain scores in Standard versus VR arms, between the first pain assessment at the time of presentation and the subsequent pain assessments up to 30 minutes after intervention.Secondary Objectives:* To compare total opioid consumption from the time of presentation to the time of discharge from acute care setting in Standard versus VR arms.* To assess the efficacy of virtual reality (VR) technology in reducing pain at 60 minutes after the first IV medication administered or 60 minutes after completion VR during an acute vaso-occlusive crisis in patients with sickle cell disease.
Research Team
Michael Frett, MD
Principal Investigator
St. Jude Children's Research Hospital
Eligibility Criteria
This trial is for individuals aged 6-25 with sickle cell disease who are experiencing a severe pain crisis and seeking care at St. Jude Children's Research Hospital. It excludes those with developmental or psychiatric disorders, other acute symptoms, mild pain, or involvement in another pain management trial.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard care therapy for VOC or standard care plus a 15-minute virtual reality session
Follow-up
Participants are monitored for changes in pain scores and opioid consumption after treatment
Treatment Details
Interventions
- Virtual Reality Therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Jude Children's Research Hospital
Lead Sponsor