Virtual Reality Therapy for Sickle Cell Crisis

Overseen By Michael Frett, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: Developmental disorders, Psychiatric disorders, others

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

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality (VR) can ease severe pain during a sickle cell crisis. Participants will receive either standard pain management or standard care plus a 15-minute VR session to determine which approach more effectively reduces pain. The goal is to discover if VR can lower pain levels within 30 minutes after treatment and decrease the need for opioid medications. This trial suits individuals with sickle cell disease experiencing an acute pain crisis and seeking care at St. Jude Children's Research Hospital. As an unphased trial, it offers a unique opportunity to explore innovative pain management techniques.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It mentions that standard pain management will continue, so it's likely you can keep taking your usual pain medicines.

What prior data suggests that virtual reality therapy is safe for patients with sickle cell disease?

Research has shown that virtual reality (VR) therapy is generally well-received by patients with sickle cell disease during a pain crisis. In one study, patients who used VR therapy alongside their usual treatments reported reduced pain. The VR sessions, typically lasting about 15 minutes, were manageable and did not cause major side effects. Although researchers continue to study VR therapy, these findings suggest it could be a safe and useful addition to traditional pain management methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtual Reality Therapy for sickle cell crises because it offers a non-invasive, drug-free option for pain management. Unlike traditional treatments, which typically involve medications like opioids for pain relief, Virtual Reality Therapy immerses patients in a digital environment, potentially distracting and reducing their perception of pain. This innovative approach could minimize the need for pain medications, reducing the risk of side effects and dependency. By providing an engaging and interactive experience, it may also improve patient comfort and overall quality of life during a vaso-occlusive crisis.

What evidence suggests that virtual reality therapy is effective for reducing pain in sickle cell crisis?

Research has shown that virtual reality (VR) therapy might help reduce pain for people with sickle cell disease during a vaso-occlusive crisis (VOC). In this trial, one group of participants will receive standard care for their VOC, while another group will receive standard care plus a 15-minute VR therapy session. Some studies have found that patients using VR therapy alongside their usual treatments reported less pain. VR can distract patients from their pain, increasing comfort. This might reduce their need for painkillers, such as opioids, to manage symptoms. Overall, early findings suggest VR could be a valuable addition to standard pain management for those experiencing a sickle cell crisis. ^{1 2 3 4 6}

Who Is on the Research Team?

Michael Frett, MD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

This trial is for individuals aged 6-25 with sickle cell disease who are experiencing a severe pain crisis and seeking care at St. Jude Children's Research Hospital. It excludes those with developmental or psychiatric disorders, other acute symptoms, mild pain, or involvement in another pain management trial.

Inclusion Criteria

Must be English speaking

I am between 6 and 25 years old.

I have sickle cell disease, as recorded in my St. Jude medical record.

Exclusion Criteria

I am unable or unwilling to give my consent to participate.

Prior randomization in this study

I experience pain along with fever, chest issues, injuries, or spleen problems needing extra care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive standard care therapy for VOC or standard care plus a 15-minute virtual reality session

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain scores and opioid consumption after treatment

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Therapy

Trial Overview The study tests if virtual reality therapy can improve pain management during a vaso-occlusive crisis when added to standard treatment. Patients will be randomly assigned to receive either the usual care or usual care plus VR therapy and their pain levels and opioid use will be compared.

How Is the Trial Designed?

Group I: Standard Care Active Control 1 Intervention

Participants receive standard care treatment for their vaso-occlusive crisis. Participants will be randomized by age.

Group II: Virtual Reality Active Control 1 Intervention

Participants receive standard care treatment for their vaso-occlusive crisis. In addition, they will have a 15-minute Virtual Reality Therapy session. Participants will be randomized by age.

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Published Research Related to This Trial

Virtual reality (VR) therapy has shown positive outcomes for various clinical conditions, including anxiety disorders and chronic pain, indicating its potential as a novel therapeutic approach.

Despite its successes, implementing VR in clinical research faces challenges such as theoretical immaturity and a lack of technical standards, which need to be addressed to enhance the rigor and clinical relevance of future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Clinical Research: Promises and Challenges. Garrett, B., Taverner, T., Gromala, D., et al.[2023]

A systematic review of 11 randomized controlled trials involving virtual reality (VR) in inpatient medical settings showed that VR is generally well tolerated and has demonstrated clinical efficacy in areas like pain management and cognitive rehabilitation.

Despite the promising results, the studies were small and varied in quality, indicating a need for larger, more controlled trials to better assess the clinical and cost-effectiveness of VR interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality and Medical Inpatients: A Systematic Review of Randomized, Controlled Trials. Dascal, J., Reid, M., IsHak, WW., et al.[2020]

Virtual reality (VR) has been found to be an effective method for reducing both acute and chronic pain, with significant improvements in pain intensity (72.1%) and quality (75.0%) observed across 70 studies involving 4105 participants.

The primary mechanism of pain relief through VR is distraction, especially for acute pain, while embodiment is more commonly associated with chronic pain, indicating that different types of pain may benefit from tailored VR approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The State of Science in the Use of Virtual Reality in the Treatment of Acute and Chronic Pain: A Systematic Scoping Review. Baker, NA., Polhemus, AH., Haan Ospina, E., et al.[2023]

Vaso-occlusive crisis in sickle cell disease causes severe pain that is often resistant to advanced pain treatments, highlighting the need for effective management strategies.

A multimodal approach combining education, cognitive therapies, anti-inflammatory drugs, opioids, and psychostimulants is currently the best available method for managing this pain, until a cure is discovered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The management of pain in sickle cell disease. Yaster, M., Kost-Byerly, S., Maxwell, LG.[2019]

Immersive virtual reality (IVR) therapy shows strong evidence for immediate and short-term pain reduction in acute pain management, based on a review of 17 studies involving 337 patients.

IVR therapy was found to be safe, with no serious adverse events reported, but more high-quality research is needed to confirm its long-term effectiveness and potential benefits for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A rapid evidence assessment of immersive virtual reality as an adjunct therapy in acute pain management in clinical practice. Garrett, B., Taverner, T., Masinde, W., 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]

In a case series involving 10 chronic pain patients, 5 reported reduced pain during virtual reality (VR) therapy sessions, suggesting potential short-term benefits of VR for pain management.

While VR therapy did not show significant overall changes in pain scores after treatment, it was safe with no serious adverse events, although 60% of participants experienced some cybersickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality as an Adjunct Home Therapy in Chronic Pain Management: An Exploratory Study. Garrett, B., Taverner, T., McDade, P.[2020]

A systematic review of 122 randomized controlled trials involving 9,138 patients found that virtual reality (VR) significantly reduces pain, with a standardized mean difference of -0.65, indicating a strong effect across various types of pain, including acute, chronic, and procedural.

The effectiveness of VR in pain management was particularly notable in younger patients and those experiencing moderate to severe pain, suggesting that VR could be a valuable tool for these groups, although the studies showed considerable variability and moderate to high risk of bias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect modifiers of virtual reality in pain management: a systematic review and meta-regression analysis. Lier, EJ., de Vries, M., Steggink, EM., et al.[2023]

A study involving 100 hospitalized patients showed that a one-time 3D virtual reality (VR) intervention significantly reduced pain more than a 2D distraction video, with an average pain reduction of -1.3 points compared to -0.6 points for the control group.

The VR intervention was not only effective, with 65% of patients experiencing a meaningful pain response, but it was also safe, as no adverse events were reported during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. Tashjian, VC., Mosadeghi, S., Howard, AR., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03353584

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. ClinicalTrials.gov ID NCT03353584.

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. 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.

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

Virtual Reality Therapy for Sickle Cell Crisis This is a phase II randomized controlled clinical trial evaluating the efficacy of virtual reality technology when added to standard pain management for ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11324415/

Feasibility of In-home Virtual Reality for Chronic Pain ... This study assessed the feasibility of an in-home virtual reality intervention for chronic pain in adults with sickle cell disease.

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/pbc.27525

Virtual reality as complementary pain therapy in ... Consecutive patients with SCD eight years and older admitted for VOE were offered one 15-minute VR session, utilizing a relaxing underwater ...