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

February 20, 2024 updated by: Richard Gentry Wilkerson, University of Maryland, Baltimore

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Systems

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Immersive Virtual Reality
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
Study Group-Virtual reality headset and hand-held controllers will be used as an adjuvant to pain management care.
Other Names:
  • Meta Quest 2
Experimental: Passive Immersive Virtual Reality
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
Study Group-Virtual reality headset and hand-held controllers will be used as an adjuvant to pain management care.
Other Names:
  • Meta Quest 2
Placebo Comparator: Blindfold and Ear Plugs
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
Control group-Blindfold and noise cancelling headphones will be a placebo comparator group to the experimental interventions of virtual reality devices.

What is the study measuring?

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.
Time Frame: A single time point 1 hour after the study intervention ends.
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
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
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.
Time Frame: Day of enrollment
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.
Time Frame: Day of enrollment
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.
Time Frame: Day of enrollment
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.
Time Frame: A single time point 1 hour after the 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.
Time Frame: A single time point at the completion of the study intervention.
Patient reported on 0-10 scale
A single time point at the completion of the study intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Investigators

  • Principal Investigator: R. Gentry Wilklerson, MD, U of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

December 14, 2023

First Posted (Actual)

December 28, 2023

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00106992

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan on sharing any individual participant data with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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