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

Trial Summary

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 data supports the effectiveness of the treatment KindVR Aqua Program 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 on hospitalized sickle cell patients found that a single VR session could improve their pain experience during painful episodes. ^{1 2 3 4 5}

Is virtual reality safe for use in humans, particularly in pediatric settings?

A study reviewing the use of virtual reality in pediatric hospitals found it to be safe, with no significant adverse events reported when used under supervision. ^{1 2 6 7 8}

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

Virtual reality (VR) is unique for sickle cell disease as it offers a non-drug approach to help manage pain during vaso-occlusive episodes, which are painful blockages in blood vessels. Unlike traditional pain medications, VR provides an immersive experience that can distract patients from pain, potentially improving their overall pain experience without the side effects of drugs. ^{1 3 9 10 11}

What is the purpose of this trial?

The goal of this randomized control clinical trial is to learn if virtual reality can be used to treat sickle cell pain in children. The main questions it aims to answer are: Does virtual reality reduce pain severity during a child's hospital stay for a vaso-occlusive pain crisis? Does virtual reality decrease the daily use of opiates? Researchers will compare standard therapy to the use of standard therapy plus a daily virtual reality experience to see if virtual reality works to treat sickle cell pain. All patients will: - Be asked to fill out a pain assessment survey three times daily for up to 3 days If randomized to intervention arm, patients will: * Participate in an immersive virtual reality experience once daily for up to 3 days * Fill out a survey twice daily to monitor for side effects from virtual reality experience * Fill out a satisfaction survey once during the study period

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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 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]

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 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]

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 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 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]

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]

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]

References

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

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

2. United States 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. [2022]

3. 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]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS) by patient-reported outcomes, actigraphy, and biomarkers. [2021]

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

An Immersive Virtual Reality Curriculum for Pediatric Hematology Clinicians on Shared Decision-making for Hydroxyurea in Sickle Cell Anemia. [2023]

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

Retrospective Review of the Safety and Efficacy of Virtual Reality in a Pediatric Hospital. [2022]

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

A feasibility randomized controlled trial of an mHealth app vs booklets for patient-facing guidelines in adults with SCD. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Feasibility and tolerability of ophthalmic virtual reality as a medical communication tool in children and young people. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Virtual reality as a therapeutic modality for children with cerebral palsy. [2022]

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

Low-cost virtual reality intervention program for children with developmental coordination disorder: a pilot feasibility study. [2015]