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Passive Immersive Virtual Reality for Sickle Cell Disease

N/A
Waitlist Available
Led By R. Gentry Wilklerson, MD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adult (age > 18 years) emergency department patient
Presenting to the emergency department due to acute pain related to sickle cell disease thought to be due to vaso-occlusive crisis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up a single time point 1 hour after the study intervention begins.
Awards & highlights

Study Summary

This trial is looking at whether virtual reality can help patients with sickle cell disease who are experiencing vaso-occlusive crises.

Who is the study for?
This trial is for patients with sickle cell disease who are currently experiencing a vaso-occlusive crisis. It's designed to see if virtual reality can help manage their pain alongside the usual treatments they receive.Check my eligibility
What is being tested?
The study tests whether using a virtual reality headset and hand-held controllers can reduce pain during a sickle cell crisis, compared to being blindfolded with noise cancellation as an alternative form of distraction.See study design
What are the potential side effects?
Since this trial involves non-invasive methods like virtual reality and sensory deprivation (blindfolding and noise cancelling), side effects may include dizziness or nausea from VR, but generally low risk of harm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 years old and currently in the emergency department.
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I am in the emergency department for severe pain from a sickle cell crisis.
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I have a history of sickle cell disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a single time point 1 hour after the study intervention ends.
This trial's timeline: 3 weeks for screening, Varies for treatment, and a single time point 1 hour after the study intervention ends. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparison of the change in pain scores between the 3 groups at one hour after completion of the study intervention.
Secondary outcome measures
Compare the total duration of Emergency Department treatment measured from the time of delivery of the first intervention to the time of disposition.
Comparison of the change in pain scores between the 3 groups at completion of the study intervention.
Comparison of the change in pain scores between the 3 groups at one hour after study intervention begins.
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Passive Immersive Virtual RealityExperimental Treatment1 Intervention
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.
Group II: Active Immersive Virtual RealityExperimental Treatment1 Intervention
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.
Group III: Blindfold and Ear PlugsPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
689 Previous Clinical Trials
374,656 Total Patients Enrolled
R. Gentry Wilklerson, MDPrincipal InvestigatorU of Maryland, Baltimore

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the process of enrolling participants still ongoing for this medical study?

"Based on the information available on clinicaltrials.gov, this particular study is currently not actively seeking participants. The trial was initially posted on January 1st, 2024 and had its most recent update on December 14th, 2023. However, it's important to note that there are currently a total of 317 other ongoing trials actively recruiting patients at this time."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Virtual Reality Devices as an Adjunct to Usual Care for Patients With Sickle Cell Disease Experiencing Vaso-Occlusive Crises
Richard Gentry Wilkerson 2024. "Virtual Reality Devices as an Adjunct to Usual Care for Patients With Sickle Cell Disease Experiencing Vaso-Occlusive Crises". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06184126.
All > Acute Pain
~20 spots leftby Sep 2024
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