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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality can help manage pain for individuals with sickle cell disease during painful episodes known as vaso-occlusive crises. Participants will try various virtual reality setups, including passive (just watching) and active (interacting) experiences, to determine if these devices can reduce pain alongside standard treatments. Individuals with sickle cell disease who frequently visit the emergency room for severe pain might be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques.

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 prior data suggests that virtual reality devices are safe for patients with sickle cell disease?

Research has shown that using virtual reality (VR) to manage pain in sickle cell disease is generally safe and well-tolerated. Studies have found that VR can reduce pain during the painful episodes common in sickle cell patients. When patients used VR alongside their regular treatments, they often experienced less pain.

Other research has demonstrated that VR is a practical option for patients hospitalized due to these painful episodes. It did not cause major side effects, and patients used it without problems. Both types of VR experiences, whether watching or interacting, have been tested and have not been linked to serious side effects.

While these studies do not list every possible side effect, the evidence suggests that VR is a safe way to help manage pain in sickle cell disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) for managing sickle cell disease because it offers a non-drug approach to pain management during acute vaso-occlusive crises. Unlike traditional treatments that rely on pain medications like opioids, VR provides a distraction technique that can potentially reduce pain perception without the side effects of drugs. The passive immersive VR experience allows patients to be visually and audibly engaged in a soothing environment, while the active immersive VR adds an interactive element, potentially enhancing the distraction effect. This innovative use of technology could offer a novel, side-effect-free option for patients looking for alternative pain management strategies.

What evidence suggests that virtual reality devices are effective for sickle cell disease?

Research has shown that virtual reality (VR) can help manage pain for people with sickle cell disease during painful episodes. This trial will randomize participants into different arms to test VR therapy's effectiveness. One arm will involve a passive immersive VR experience, where participants watch without interaction, while another will involve an active immersive VR experience, allowing interaction with the virtual environment. Studies have found that using VR alongside regular treatments might reduce pain, and patients have reported feeling less pain with both types of VR experiences. VR therapy is considered a promising tool for managing sickle cell pain and could be a useful addition to current care methods. ^{1 3 4 6 7}

Who Is on the Research Team?

R. Gentry Wilklerson, MD

Principal Investigator

U of Maryland, Baltimore

Are You a Good Fit for This Trial?

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

Medical history of seizures or known intolerance to virtual reality

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06773715

Virtual Reality As Adjunct Therapy for Vaso-Occlusive Pain

The goal of this randomized control clinical trial is to learn if virtual reality can be used to treat sickle cell pain in children.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30362236/

Virtual reality as complementary pain therapy in ...

VR therapy was feasible in a cohort of patients with SCD admitted for VOE. In addition to standard therapies, VR may help reduce the pain experience with SCD ...

3.

withpower.com

withpower.com/trial/virtual-reality-therapy-for-sickle-cell-crisis-86033

Virtual Reality Therapy for Sickle Cell Crisis

PRIMARY OBJECTIVE: To assess the efficacy of virtual reality (VR) technology in reducing pain at 30 minutes after intervention during an acute vaso-occlusive ...

4.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT03353584/effect-of-virtual-reality-technology-for-pain-management-of-vaso-occlusive-crisis-in-patients-with-sickle-cell-disease

Effect of Virtual Reality Technology for Pain Management ...

Effect of Virtual Reality Technology for Pain Management of Vaso-Occlusive Crisis in Patients With Sickle Cell Disease. Last updated ...

5.

link.springer.com

link.springer.com/article/10.1007/s11606-025-09812-z

Relief Exploration for Sickle Pain Through Interventions ...

The present study identifies that people with SCD regard VR as a promising intervention for pain management. Future studies include designing ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05864092

Virtual Reality as an Adjuvant Therapy for Sickle Cell Vaso ...

The study aims to add VR to standard of care medical treatment for pediatric patients with sickle cell disease who present to the pediatric emergency department ...

7.

hematologyadvisor.com

hematologyadvisor.com/news/home-virtual-reality-chronic-pain-scd-sickle-cell-disease/

In-Home Virtual Reality Application Potentially Useful ...

A novel in-home virtual reality application for the self-management of chronic pain in adult patients with sickle cell disease (SCD) has ...