Virtual Reality Devices as an Adjunct to Usual Care for Patients With Sickle Cell Disease Experiencing Vaso-Occlusive Crises

Study Overview
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Brief Summary
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This study aims to evaluate the use of virtual reality as an adjunct to standard care for patients with sickle cell disease experiencing vaso-occlusive crises.

Detailed Description
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A prospective, non-blinded, non-randomized trial will be conducted at the Adult Emergency Department at the University of Maryland Medical Center and Adult Urgent Care Center, which is managed by the Department of Emergency Medicine, located in Baltimore, Maryland. Patients meeting eligibility criteria and who have signed the research informed consent will be enrolled in this study. Subject data collected will include demographic information, symptoms of the current illness and physical exam findings. Upon enrollment into the study, a study team member will interview the patient to collect data needed to complete the Case Report Form. Patients assigned to one of the two virtual reality study groups will be directed by research coordinators who can help with equipment as needed throughout the session. The virtual reality device will be limited to a maximum of 2 hours of use. Assessments will be made at 4 different timepoints: 1) Immediately before the intervention, 2) at the 1-hour mark of the intervention, 3) immediately after the intervention, and 4) 1 hour after the intervention. During these assessments, patients will rate their pain intensity using a 0-10 numerical scale. Additionally, at each assessment, patients will be asked to state the change in pain that has taken place since the last measurement. This measurement will be performed without informing the patient of their previously recorded pain scores. Data will also be recorded regarding the patient's 1) comfort of the device, 2) disposition (discharged home vs observation/admission status), 3) total length of treatment time in the ED (measured as time to initiation of any treatment to the time of final disposition), and 4) total amount of opioids administered while under the care of the emergency department clinicians, converted into morphine milligram equivalents. Each patient will complete a questionnaire at the conclusion of the session regarding their perceived impact of the intervention, ease of use, and likelihood to reuse the intervention.

Official Title
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Pilot Study to Investigate the Use of Virtual Reality Devices as an Adjunct to Usual Care for Patients With Sickle Cell Disease Experiencing Vaso-Occlusive Crises

Conditions
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Sickle Cell Disease, Vaso-occlusive Pain Episode in Sickle Cell Disease, Acute Pain

Intervention / Treatment
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* Device: Virtual Reality Headset and Hand-Held Controllers
* Other: Blindfolding and Noise Cancelling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (age > 18 years) emergency department patient History of sickle cell disease Presenting to the emergency department due to acute pain related to sickle cell disease thought to be due to vaso-occlusive crisis 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 Disabilities like vision and hearing defects etc. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective, non-blinded, randomized clinical control trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Immersive Virtual Reality<br>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 headset with hand-held controllers. The active immersive application will allow the user to interact directly with the application and move through the virtual environment .The patient will be able to use the active immersive application on the device for a maximum of two hours. | Device: Virtual Reality Headset and Hand-Held Controllers<br>* Study Group-Virtual reality headset and hand-held controllers will be used as an adjuvant to pain management care.<br>* Other names: Meta Quest 2;|
| Experimental: Passive Immersive Virtual Reality<br>Patient with sickle cell disease experiencing acute vaso-occlusive crisis randomized to this arm will participate in a passive immersive application on the virtual reality headset with hand-held controllers. The passive immersive application will not allow the user to interact directly with the application or move through the virtual environment .The patient will be able to use the passive immersive application on the device for a maximum of two hours. | Device: Virtual Reality Headset and Hand-Held Controllers<br>* Study Group-Virtual reality headset and hand-held controllers will be used as an adjuvant to pain management care.<br>* Other names: Meta Quest 2;|
| Placebo Comparator: Blindfold and Ear Plugs<br>Patient with sickle cell disease experiencing acute vaso-occlusive crisis randomized to this arm will wear a blindfold and ear plugs. The patient will be able to remain blindfolded and earplugs for a maximum of two hours. | Other: Blindfolding and Noise Cancelling<br>* Control group-Blindfold and noise cancelling headphones will be a placebo comparator group to the experimental interventions of virtual reality devices.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the change in pain scores between the 3 groups at one hour after completion of the study intervention. | Patient reported on 0-10 scale | A single time point 1 hour after the study intervention ends. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the subject's assessment of comfort of the study intervention between the 3 groups | Patient reported on 1-5 Likert scale | Immediately before intervention, at 1-hour mark of the intervention, immediately following the intervention, and 1 hour after the intervention ends. | 
| Comparison of the proportion of subjects within each group who are hospitalized. | Determine whether the patient is discharged home vs. placed in observation/admission status after completion of emergency department care. | Day of enrollment | 
| Compare the total duration of Emergency Department treatment measured from the time of delivery of the first intervention to the time of disposition. | Measured in hours/minutes | Day of enrollment | 
| Comparison of the quantity opioids, converted to morphine milligram equivalents, administered while under the care of the ED clinical team. | Measured in morphine milligram equivalents | Day of enrollment | 
| Comparison of the change in pain scores between the 3 groups at one hour after study intervention begins. | Patient reported on 0-10 scale | A single time point 1 hour after the study intervention begins. | 
| Comparison of the change in pain scores between the 3 groups at completion of the study intervention. | Patient reported on 0-10 scale | A single time point at the completion of the study intervention. |