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NCT Number: NCT06184126

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland Medical Systems

Baltimore, Maryland, 21201, United States

Location status: Recruiting

Location contact

R. Gentry Wilkerson, MD

CONTACT

[email protected]

410-328-4237

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Headset and Hand-Held Controllers

Device

Study Group-Virtual reality headset and hand-held controllers will be used as an adjuvant to pain management care.

Other names: Meta Quest 2

Blindfolding and Noise Cancelling

Other

Control group-Blindfold and noise cancelling headphones will be a placebo comparator group to the experimental interventions of virtual reality devices.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

R. Gentry Wilkerson, MD

CONTACT

[email protected]

410-328-4237

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 28, 2023
Registry last updated
Dec 24, 2025

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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