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Virtual Reality for Sickle Cell Disease

N/A

Recruiting

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

Must not have

Patients who lack the capacity to provide informed consent

Over the age of 89 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up a single time point 1 hour after the study intervention begins.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand or sign the consent form by myself.

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I am over 89 years old.

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I am not currently receiving IV opioids for pain crises.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ a single time point 1 hour after the study intervention ends.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparison of the change in pain scores between the 3 groups at one hour after completion of the study intervention.

Secondary study objectives

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.

0 / 6Eligibility criteria met