University of Maryland Medical Systems
Baltimore, Maryland, 21201, United States
Location status: Recruiting
NCT Number: NCT06184126
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Baltimore, Maryland, 21201, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Study Group-Virtual reality headset and hand-held controllers will be used as an adjuvant to pain management care.
Other names: Meta Quest 2
Control group-Blindfold and noise cancelling headphones will be a placebo comparator group to the experimental interventions of virtual reality devices.
Time frame: A single time point 1 hour after the study intervention ends.
Patient reported on 0-10 scale
Time frame: Immediately before intervention, at 1-hour mark of the intervention, immediately following the intervention, and 1 hour after the intervention ends.
Patient reported on 1-5 Likert scale
Time frame: Day of enrollment
Determine whether the patient is discharged home vs. placed in observation/admission status after completion of emergency department care.
Time frame: Day of enrollment
Measured in hours/minutes
Time frame: Day of enrollment
Measured in morphine milligram equivalents
Time frame: A single time point 1 hour after the study intervention begins.
Patient reported on 0-10 scale
Time frame: A single time point at the completion of the study intervention.
Patient reported on 0-10 scale
Contact information is provided by the study sponsor or research team.
University of Maryland, Baltimore
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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