Virtual Reality for Sickle Cell Disease

Overseen By Casey M Treuting, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Louisiana State University Health Sciences Center in New Orleans

Disqualifiers: Acute chest syndrome, Splenic sequestration, Post-operative pain, Cerebrovascular accident, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3 days

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality, specifically the KindVR Aqua Program, can ease pain for children with sickle cell disease during a vaso-occlusive pain crisis. During such a crisis, red blood cells block blood flow, causing intense pain. Researchers aim to determine if virtual reality can reduce pain and decrease the need for opiates, compared to standard treatments alone. Children experiencing these intense pain episodes and hospitalized for treatment may be suitable participants. As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative research that could transform pain management for sickle cell disease.

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 to focus on adding virtual reality to standard therapy, so you may be able to continue your current treatment.

What prior data suggests that virtual reality is safe for treating sickle cell pain in children?

Research has shown that virtual reality (VR) treatments like the KindVR Aqua Program are generally manageable for patients with sickle cell disease. In past studies, patients who used VR alongside their usual pain treatments reported reduced pain. No major side effects were reported. Most participants found the VR experience easy to manage, and any mild discomfort was brief.

In these VR studies, patients often completed surveys to check for side effects, which did not reveal any major issues. This suggests that VR is a safe option to consider as an additional method for managing sickle cell pain. However, as with any treatment, experiences can vary, so it is important to inform the medical team about any discomfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the KindVR Aqua Program for treating vaso-occlusive pain in sickle cell disease because it offers an innovative, drug-free approach to pain management. Unlike the standard treatments that rely on IV fluids, NSAIDs, and opiates, this virtual reality experience aims to help patients manage pain through immersive distraction techniques. It provides a new way to potentially reduce pain perception without the side effects associated with medications, offering a unique and engaging pain relief option that could enhance patients' quality of life.

What evidence suggests that virtual reality is effective for treating sickle cell pain?

Research has shown that virtual reality (VR) can reduce pain and anxiety in people with various health conditions, including sickle cell disease. One study found that VR use lowered pain levels shortly after use during a sickle cell pain crisis, a painful blockage in blood vessels. In this trial, participants in the experimental arm will have the opportunity to use the KindVR Aqua Program alongside standard care. In other contexts, VR has provided a calming and distracting experience, making pain easier to manage. Although specific data for sickle cell pain is limited, these findings suggest that VR could be a useful tool for reducing pain during a crisis. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for children with sickle cell disease experiencing vaso-occlusive pain crises. Participants must be hospitalized for the pain crisis and able to complete surveys. Specific inclusion or exclusion criteria are not provided, but typically these would detail age range, severity of condition, and any other health requirements or restrictions.

Inclusion Criteria

No known cognitive or neurological deficits

I am between 8 and 21 years old.

I am admitted for severe pain management due to a sickle cell crisis.

Exclusion Criteria

Patient has previously participated in the study

My sickle cell disease needs more than usual pain treatment.

The study team cannot start the study treatment within 24 hours of my admission.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive standard therapy with or without daily virtual reality experience for up to 3 days

3 days

Daily in-hospital visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

Not applicable

What Are the Treatments Tested in This Trial?

Interventions

• KindVR Aqua Program

Trial Overview The study tests if virtual reality can reduce pain and opiate use in children with sickle cell disease during hospital stays for vaso-occlusive crises. It compares standard therapy alone to standard therapy plus a daily virtual reality program called KindVR Aqua Program.

How Is the Trial Designed?

Group I: Cases Experimental Treatment 1 Intervention

In addition to receiving the standard of care for their vaso-occlusive pain, the case patients will have the opportunity to participate in the immersive VR experience after completing their initial pain assessment simulator sickness survey. Following the intervention, their pain levels will be reassessed at the 1-hour and 4-hour mark from their baseline assessment. Additionally, they will be asked to fill out an additional simulator sickness survey upon completion of the VR experience. This same timeline will occur on days 2 and 3 of admission. Prior to discharge or discontinuation from the study, the case patients will be asked to fill out the post-study questionnaire.

Group II: Controls Active Control 1 Intervention

Control patients will continue to receive the standard of care for their vaso-occlusive pain (IV fluid hydration, scheduled IV NSAID, and opiate medication) and have repeat pain assessments at 1 hour and 4 hours from their baseline assessment. This same timeline will occur on days 2 and 3 of admission

Who Is Running the Clinical Trial?

Louisiana State University Health Sciences Center in New Orleans

Lead Sponsor

Trials

123

Recruited

42,400+

KindVR

Collaborator

Trials

3

Recruited

160+

Published Research Related to This Trial

An immersive virtual reality (VR) training program was implemented at 8 pediatric institutions to improve clinicians' skills in shared decision-making (SDM) for initiating hydroxyurea (HU) treatment in sickle cell anemia.

After the VR training, clinicians reported significant improvements in their confidence regarding communication skills necessary for SDM, such as asking open-ended questions and confirming patient understanding, indicating that VR could be an effective educational tool for enhancing clinician-patient interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Immersive Virtual Reality Curriculum for Pediatric Hematology Clinicians on Shared Decision-making for Hydroxyurea in Sickle Cell Anemia. Real, FJ., Hood, AM., Davis, D., et al.[2023]

A study involving 3,696 pediatric patients showed that virtual reality (VR) is safe for use, with very few adverse events reported, such as increased anxiety in 3.8% of cases and dizziness or nausea in less than 1%.

The use of VR significantly improved patient cooperation during medical procedures, with 99.5% of patients being cooperative after VR intervention compared to 96.7% before, indicating its efficacy in enhancing the patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Review of the Safety and Efficacy of Virtual Reality in a Pediatric Hospital. Caruso, TJ., O'Connell, C., Qian, JJ., et al.[2022]

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 study involving 206 children and young people showed that a virtual reality (VR) application effectively helped them understand ophthalmological complications, indicating its potential as a valuable educational tool in medicine.

The VR platform was well-received, with nearly half of the participants being new to VR, and it successfully increased their interest in science, suggesting that VR can enhance engagement and communication in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and tolerability of ophthalmic virtual reality as a medical communication tool in children and young people. Maloca, PM., Williams, EA., Mushtaq, F., et al.[2022]

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]

A study involving 46 children with sickle cell disease showed that cognitive-behavioral therapy (CBT) delivered via smartphones significantly improved active coping skills over an 8-week period.

Using CBT skills on days with higher pain levels was associated with reduced next-day pain intensity, indicating that this intervention can effectively help manage pain in pediatric patients with sickle cell disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in coping, pain, and activity after cognitive-behavioral training: a randomized clinical trial for pediatric sickle cell disease using smartphones. Schatz, J., Schlenz, AM., McClellan, CB., et al.[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]

Virtual reality (VR) shows potential benefits for children with cerebral palsy (CP), with positive outcomes reported in areas like motor capacity and social participation across 12 out of 13 studies analyzed.

Despite some promising results, the overall quality of evidence is low, and more rigorous studies are needed to better understand the efficacy of VR as an intervention for CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality as a therapeutic modality for children with cerebral palsy. Snider, L., Majnemer, A., Darsaklis, V.[2022]

The study enrolled 37 participants with sickle cell disease over 6 months, successfully using electronic patient-reported outcomes (ePRO) and actigraphy to monitor pain and activity, revealing significant changes in pain and functionality on days with vaso-occlusive crises (VOCs).

Biomarkers collected during VOCs showed significant alterations compared to baseline values, indicating that these biological changes could help in identifying and assessing VOCs more effectively in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS) by patient-reported outcomes, actigraphy, and biomarkers. Pittman, DD., Hines, PC., Beidler, D., et al.[2021]

A feasibility randomized controlled trial involving 67 adults with sickle cell disease (SCD) showed high recruitment (91%) and retention (75%) rates for a mobile health app designed to improve patient knowledge and potentially reduce hospitalizations.

All participants in the treatment group used the mHealth app, indicating strong adherence to the intervention, which suggests that mobile health tools can be effectively integrated into patient care for SCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility randomized controlled trial of an mHealth app vs booklets for patient-facing guidelines in adults with SCD. Cronin, RM., Quaye, N., Liu, X., et al.[2023]

A study involving 9 children aged 4 to 6 years with suspected developmental coordination disorder (DCD) showed that using a low-cost virtual reality game in 10 sessions significantly improved their motor function, as indicated by better scores on the Movement Assessment Battery for Children-2 (M-ABC-2).

The children not only demonstrated improved balance and overall movement skills but also appeared motivated and enjoyed the VR experience, suggesting that this intervention could be a fun and effective way to support motor development in young children with DCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-cost virtual reality intervention program for children with developmental coordination disorder: a pilot feasibility study. Ashkenazi, T., Weiss, PL., Orian, D., et al.[2015]

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. withpower.com withpower.com/trial/phase-anemia-sickle-cell-8-2024-58cc0

Virtual Reality for Sickle Cell Disease Research suggests that virtual reality (VR) can help reduce pain and anxiety in various conditions, including sickle cell disease and type 1 diabetes. A study ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03353584?draw=2&rank=1

Effect of Virtual Reality Technology for Pain Management ... 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. kindvr.com kindvr.com/news

News A program to provide patient's virtual and augmented reality experiences to distract them and create a calming environment during their procedures.

5. 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 ...

6. cayennewellness.org cayennewellness.org/wp-content/uploads/2019/09/Simon-Robertson.pdf

Virtual Reality as a Complementary Pain Therapy for Sickle ... To determine if a virtual reality immersive experience serves as an effective adjunctive therapy to traditional pain reduction treatments in.

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/570217

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.