Clinical trial NCT06184126: Virtual Reality Devices As an Adjunct to Usual Care for Patients with Sickle Cell Disease Experiencing Vaso-Occlusive Crises
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sickle Cell Disease
Vaso-occlusive Pain Episode in Sickle Cell Disease
Acute Pain
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, non-blinded, randomized clinical control trial.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the change in pain scores between the 3 groups at one hour after completion of the study intervention.
timeFrame: A single time point 1 hour after the study intervention ends.
Secondary outcomes:
measure: Comparison of the subject's assessment of comfort of the study intervention between the 3 groups
timeFrame: Immediately before intervention, at 1-hour mark of the intervention, immediately following the intervention, and 1 hour after the intervention ends.
measure: Comparison of the proportion of subjects within each group who are hospitalized.
timeFrame: Day of enrollment
measure: Compare the total duration of Emergency Department treatment measured from the time of delivery of the first intervention to the time of disposition.
timeFrame: Day of enrollment
measure: Comparison of the quantity opioids, converted to morphine milligram equivalents, administered while under the care of the ED clinical team.
timeFrame: Day of enrollment
measure: Comparison of the change in pain scores between the 3 groups at one hour after study intervention begins.
timeFrame: A single time point 1 hour after the study intervention begins.
measure: Comparison of the change in pain scores between the 3 groups at completion of the study intervention.
timeFrame: A single time point at the completion of the study intervention.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Systems
state: Maryland
Study officials:
affiliation: U of Maryland, Baltimore
name: R. Gentry Wilklerson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sundd P, Gladwin MT, Novelli EM. Pathophysiology of Sickle Cell Disease. Annu Rev Pathol. 2019 Jan 24;14:263-292. doi: 10.1146/annurev-pathmechdis-012418-012838. Epub 2018 Oct 17.
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citation: Duroseau Y, Beenhouwer D, Broder MS, Brown B, Brown T, Gibbs SN, Jackson K, Liang S, Malloy M, Romney ML, Shani D, Simon J, Yermilov I. Developing an emergency department order set to treat acute pain in sickle cell disease. J Am Coll Emerg Physicians Open. 2021 Aug 7;2(4):e12487. doi: 10.1002/emp2.12487. eCollection 2021 Aug.
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