Virtual Reality for Sickle Cell Disease

Overseen By R. Gentry Wilkerson, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must be taking: Intravenous opioids

Disqualifiers: Seizures, Pregnancy, Incarceration, others

Stay on Your Current Meds You can continue your current medications while participating

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using virtual reality alongside standard care, so you may not need to stop your medications, but it's best to confirm with the trial organizers.

What data supports the effectiveness of the treatment Virtual Reality Devices, VR Therapy, Virtual Reality Technology, Immersive VR for Sickle Cell Disease?

Research suggests that virtual reality (VR) can be a helpful complementary therapy for managing pain in hospitalized patients with sickle cell disease, as it may improve the pain experience during vaso-occlusive episodes. ^{1 2 3 4 5}

How does virtual reality treatment differ from other treatments for sickle cell disease?

Virtual reality (VR) treatment for sickle cell disease is unique because it uses immersive technology to help manage pain during vaso-occlusive episodes, which are painful events common in this condition. Unlike traditional pain management methods that rely on medication, VR offers a non-drug approach by providing a distraction and potentially reducing the perception of pain. ^{1 3 5 6 7}

Research Team

R. Gentry Wilklerson, MD

Principal Investigator

U of Maryland, Baltimore

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 years old and currently in the emergency department.

I am in the emergency department for severe pain from a sickle cell crisis.

I have a history of sickle cell disease.

Exclusion Criteria

Prior enrollment in this study

Incarcerated at the time of evaluation

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants use virtual reality devices or placebo for a maximum of 2 hours during a single session in the emergency department

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain scores and other outcomes immediately after the intervention and 1 hour post-intervention

1 day

Multiple assessments during the visit

Treatment Details

Interventions

• Virtual Reality Devices

Trial Overview 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.

Participant Groups

Group I: Passive Immersive Virtual Reality Experimental Treatment 1 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 Reality Experimental Treatment 1 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 Plugs Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Findings from Research

A study involving 30 patients with sickle cell disease showed that a 15-minute immersive virtual reality (VR) session was safe and well-accepted, with no reported side effects and all patients wanting to use VR again.

The VR session significantly reduced pain intensity and the number of affected body areas, suggesting that VR could be a beneficial complementary therapy for managing vaso-occlusive pain episodes in sickle cell disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality as complementary pain therapy in hospitalized patients with sickle cell disease. Agrawal, AK., Robertson, S., Litwin, L., et al.[2019]

A scoping review of 21 studies on the use of Virtual Reality (VR) in intensive care patients indicates that VR interventions for relaxation and delirium are well-tolerated, with completion rates of 73.6% and 52.7%, respectively.

While VR shows potential benefits for relaxation, delirium, and sleep improvement in ICU settings, it is still in the early stages of research and requires further robust studies before being recommended for routine clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scoping review of the use of virtual reality in intensive care units. Hill, JE., Twamley, J., Breed, H., et al.[2022]

Virtual reality (VR) is increasingly being integrated into complementary and alternative medicine (CAM), showing promising results in clinical applications over the past 20 years.

The review suggests that while more research is needed, VR is expected to become a crucial tool for CAM practitioners and researchers, enhancing the effectiveness and appeal of digital health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Virtual Reality Technology in Clinical Practice, Teaching, and Research in Complementary and Alternative Medicine. Guan, H., Xu, Y., Zhao, D.[2022]

The mobile game-based VR rehabilitation program (MoU-Rehab) significantly improved upper extremity function in stroke patients compared to conventional therapy, as measured by the Fugl-Meyer Assessment and other metrics.

The program was well-tolerated with no adverse effects reported, and patients expressed high satisfaction, indicating its feasibility as a rehabilitation tool for upper limb recovery after ischemic stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile game-based virtual reality rehabilitation program for upper limb dysfunction after ischemic stroke. Choi, YH., Ku, J., Lim, H., et al.[2019]

A systematic review of 31 studies involving 2407 health professionals found that virtual reality (VR) significantly improves knowledge and cognitive skills compared to traditional education methods, with a moderate effect size for knowledge (SMD=0.44) and a large effect size for cognitive skills (SMD=1.12).

While VR shows promise in enhancing educational outcomes, the evidence for its impact on attitudes and satisfaction is mixed, and no studies reported on patient-related outcomes or adverse effects, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality for Health Professions Education: Systematic Review and Meta-Analysis by the Digital Health Education Collaboration. Kyaw, BM., Saxena, N., Posadzki, P., et al.[2023]

In a study involving 40 children with type 1 diabetes, virtual reality (VR) technology significantly reduced pain scores by 30% and anxiety scores by 14% compared to baseline, demonstrating its effectiveness in managing discomfort and stress associated with diabetes care.

VR also improved glycemic control measures and patient-reported satisfaction sixfold compared to traditional audio-guided techniques, suggesting that incorporating VR into diabetes management could enhance adherence and overall coping strategies for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality's impact on children with type 1 diabetes: a proof-of-concept randomized cross-over trial on anxiety, pain, adherence, and glycemic control. Gruber, N., Shemesh-Iron, M., Kraft, E., et al.[2023]

The study demonstrated that using an Apple Watch to remotely monitor physiological data is feasible for patients with sickle cell disease during hospitalization for vaso-occlusive crises and up to 30 days post-discharge.

A machine learning model, specifically a random forest model, achieved high accuracy (92%) in predicting pain scores based on data collected from the wearable device, indicating its potential for timely intervention in managing pain episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of consumer wearables to monitor and predict pain in patients with sickle cell disease. Vuong, C., Utkarsh, K., Stojancic, R., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Virtual reality as complementary pain therapy in hospitalized patients with sickle cell disease. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Scoping review of the use of virtual reality in intensive care units. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Application of Virtual Reality Technology in Clinical Practice, Teaching, and Research in Complementary and Alternative Medicine. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile game-based virtual reality rehabilitation program for upper limb dysfunction after ischemic stroke. [2019]

5. Canada pubmed.ncbi.nlm.nih.gov

Virtual Reality for Health Professions Education: Systematic Review and Meta-Analysis by the Digital Health Education Collaboration. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Virtual reality's impact on children with type 1 diabetes: a proof-of-concept randomized cross-over trial on anxiety, pain, adherence, and glycemic control. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Use of consumer wearables to monitor and predict pain in patients with sickle cell disease. [2023]