Virtual Reality Therapy for Sickle Cell Crisis
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: St. Jude Children's Research Hospital
Disqualifiers: Developmental disorders, Psychiatric disorders, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
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.
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.
12345Is virtual reality therapy safe for humans?
Virtual reality therapy has been used safely in many studies for managing pain in both adults and children, with few reports of adverse events (unwanted side effects). However, more research is needed to fully understand its safety, especially in different populations and conditions.
12678How 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.
12789Eligibility 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
I am between 6 and 25 years old.
Must be English speaking
I have sickle cell disease, as recorded in my St. Jude medical record.
+1 more
Exclusion Criteria
I am unable or unwilling to give my consent to participate.
Prior randomization in this study
I experience pain along with fever, chest issues, injuries, or spleen problems needing extra care.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive standard care therapy for VOC or standard care plus a 15-minute virtual reality session
1 day
1 visit (in-person)
Follow-up
Participants are monitored for changes in pain scores and opioid consumption after treatment
1 day
1 visit (in-person)
Participant Groups
The study tests if virtual reality therapy can improve pain management during a vaso-occlusive crisis when added to standard treatment. Patients will be randomly assigned to receive either the usual care or usual care plus VR therapy and their pain levels and opioid use will be compared.
2Treatment groups
Active Control
Group I: Standard CareActive Control1 Intervention
Participants receive standard care treatment for their vaso-occlusive crisis. Participants will be randomized by age.
Group II: Virtual RealityActive Control1 Intervention
Participants receive standard care treatment for their vaso-occlusive crisis. In addition, they will have a 15-minute Virtual Reality Therapy session. Participants will be randomized by age.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
St. Jude Children's Research HospitalMemphis, TN
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Who Is Running the Clinical Trial?
St. Jude Children's Research HospitalLead Sponsor
References
Virtual Reality as an Adjunct Home Therapy in Chronic Pain Management: An Exploratory Study. [2020]Virtual reality (VR) therapy has been successfully used as an adjunct therapy for the management of acute pain in adults and children, and evidence of potential efficacy in other health applications is growing. However, minimal research exists on the value of VR as an intervention for chronic pain.
Virtual reality as complementary pain therapy in hospitalized patients with sickle cell disease. [2019]Due to incomplete management of vaso-occlusive pain episodes (VOE) in patients with sickle cell disease (SCD), we sought to determine if immersive VR would be feasible for inpatients. Secondarily, we hypothesized that a single VR session would improve the VOE pain experience.
Effect modifiers of virtual reality in pain management: a systematic review and meta-regression analysis. [2023]There is a rapidly growing body of evidence for the application of virtual reality (VR) in pain management, however, with varying effectiveness. Little is known about patient-related and VR-related factors affecting efficacy of VR. A systematic review and meta-analysis was performed including 122 randomised controlled trials (9138 patients), reporting on subjectively reported pain scores comparing an immersive VR intervention to a non-VR control group. Virtual reality significantly reduced pain in the pooled analysis (standardized mean difference = -0.65, 95% CI -0.76 to -0.54, P
Virtual Reality and Medical Inpatients: A Systematic Review of Randomized, Controlled Trials. [2020]Objective: We evaluated the evidence supporting the use of virtual reality among patients in acute inpatient medical settings. Method: We conducted a systematic review of randomized controlled trials conducted that examined virtual reality applications in inpatient medical settings between 2005 and 2015. We used PsycINFO, PubMed, and Medline databases to identify studies using the keywords virtual reality, VR therapy, treatment, and inpatient.Results: We identified 2,024 citations, among which 11 met criteria for inclusion. Studies addressed three general areas: pain management, eating disorders, and cognitive and motor rehabilitation. Studies were small and heterogeneous and utilized different designs and measures. Virtual reality was generally well tolerated by patients, and a majority of studies demonstrated clinical efficacy. Studies varied in quality, as measured by an evaluation metric developed by Reisch, Tyson, and Mize (average quality score=0.87; range=0.78-0.96). Conclusion: Virtual reality is a promising intervention with several potential applications in the inpatient medical setting. Studies to date demonstrate some efficacy, but there is a need for larger, well-controlled studies to show clinical and cost-effectiveness.
Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. [2020]Improvements in software and design and reduction in cost have made virtual reality (VR) a practical tool for immersive, three-dimensional (3D), multisensory experiences that distract patients from painful stimuli.
The State of Science in the Use of Virtual Reality in the Treatment of Acute and Chronic Pain: A Systematic Scoping Review. [2023]Previous reviews have reported virtual reality (VR) to be an effective method to treat pain. This scoping review examines the state of the science for VR and pain both generally and by pain type (acute and chronic) related to types of mechanisms, dosage, effectiveness, and adverse events (AEs). We searched online databases PubMed, Web of Science, PsychInfo, and CINAHL from 2010 to 2020 and included studies from peer reviewed journals that examined people with pain, (excluding pain-free participants) with a primary outcome measuring pain. We assessed studies for risk of bias using PEDro criteria. We described data through counts and percentages. Significant results were determined through P-values. We found 70 studies representing 4105 people; 46 acute pain studies (65.7%), 22 chronic pain studies (31.4%), and 2 (2.9%) "both." The most common VR mechanism was distraction (78.6%) then embodiment (17.1%). However, distraction was the mechanism for 97.8% acute pain studies while embodiment was more common for chronic pain (54.5%). Dosage of VR was inconsistently reported and varied considerably. VR treatment groups showed significant improvements in pain, particularly for intensity of pain (72.1%) and quality of pain (75.0%). Few studies examined AEs. Limitations of this review include only examining last 10 years of articles and that many studies were missing data. VR appears to be an effective intervention to address both acute and chronic pain. Research evaluating VR mechanisms, dosage, and AEs is warranted, as is further work in under-served populations (children for chronic pain and older adults) as the current evidence is largely limited to adult populations with pain.
Virtual Reality Clinical Research: Promises and Challenges. [2023]Virtual reality (VR) therapy has been explored as a novel therapeutic approach for numerous health applications, in which three-dimensional virtual environments can be explored in real time. Studies have found positive outcomes for patients using VR for clinical conditions such as anxiety disorders, addictions, phobias, posttraumatic stress disorder, eating disorders, stroke rehabilitation, and for pain management.
A rapid evidence assessment of immersive virtual reality as an adjunct therapy in acute pain management in clinical practice. [2022]Immersive virtual reality (IVR) therapy has been explored as an adjunct therapy for the management of acute pain among children and adults for several conditions. Therapeutic approaches have traditionally involved medication and physiotherapy but such approaches are limited over time by their cost and side effects. This review seeks to critically evaluate the evidence for and against IVR as an adjunctive therapy for acute clinical pain applications.
The management of pain in sickle cell disease. [2019]The pain of vaso-occlusive crisis in patients with sickle cell disease is excruciating, incapacitating, and sometimes refractory to even the most advanced analgesic treatments. A comprehensive, multimodal approach to therapy that includes education, cognitive therapies, anti-inflammatory drugs, opioids, and psychostimulant adjuvant drugs has been presented. Until a cure for the underlying disease is found, these are the best approaches available. The authors hope that future research will find even better modalities of analgesic care.