Virtual Reality Gaming for Pediatric Cancer

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: University of Alabama at Birmingham

Disqualifiers: Blindness, Deafness, Motion sickness, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will explore the potential benefits of a virtual reality gaming program that focuses on mindfulness and exercise among pediatric cancer rehabilitation patients. The program will last 8 weeks outside of the hospital. Participants will start immediately in the hospital (immediate start group) or wait 8 weeks after hospital discharge to start the program (waitlist control group).

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Virtual Reality Exercise and Mindfulness Gaming for pediatric cancer?

Research shows that virtual reality (VR) can help reduce symptoms like anxiety, depression, and pain in cancer patients, and it has been used successfully in pediatric rehabilitation for conditions like cerebral palsy. This suggests that VR could be beneficial for children with cancer by making rehabilitation more engaging and effective. ^{1 2 3 4 5}

Is virtual reality gaming safe for children, including those with cancer?

Research on virtual reality gaming, including studies on children with various conditions, suggests it is generally safe. For example, a pilot trial in critically ill children found virtual reality exercise to be a feasible and safe rehabilitation intervention. ^{6 7 8 9 10}

How is the Virtual Reality Exercise and Mindfulness Gaming treatment different from other treatments for pediatric cancer?

This treatment is unique because it combines virtual reality gaming with exercise and mindfulness, providing an engaging way to improve physical coordination and reduce pain and anxiety in children with cancer. Unlike traditional treatments, it uses interactive simulations to create a motivating environment for active learning and rehabilitation. ^{1 2 6 10 11}

Research Team

Eligibility Criteria

This trial is for children undergoing cancer rehabilitation. They must be able to participate in virtual reality gaming and mindfulness exercises over an 8-week program, starting either immediately or after a wait period.

Inclusion Criteria

Presence of a caregiver who can assist the child with the study procedures

I am older than 7 years.

I need a stem cell transplant for my cancer or other serious illness.

Exclusion Criteria

Complete blindness or deafness

I cannot use hand-held controllers.

Susceptible to motion sickness in virtual reality

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate Start Treatment

Participants start the virtual reality gaming program in the hospital and continue for 8 weeks after hospital discharge

8 weeks

Hospital start, then home-based

Waitlist Control Treatment

Participants wait 8 weeks after hospital discharge before starting the 8-week virtual reality gaming program

8 weeks

Home-based

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Virtual Reality Exercise and Mindfulness Gaming (Behavioral Intervention)

Trial Overview The study tests if virtual reality games that focus on exercise and mindfulness can benefit kids recovering from cancer. It compares two groups: one starts the program right away, the other waits for 8 weeks before beginning.

Participant Groups

Group I: Immediate Start Experimental Treatment 1 Intervention

Program starts in the hospital and lasts for 8 weeks after hospital discharge.

Group II: Waitlist Control Active Control 1 Intervention

After 8 weeks after hospital discharge, these participants start the 8 week intervention.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

Findings from Research

A systematic review of six randomized controlled trials involving 379 pediatric cancer patients found that virtual reality (VR) significantly reduces pain, anxiety, and fear symptoms, indicating its efficacy as a supportive treatment.

The results showed a notable decrease in pain (mean difference of -4.82), anxiety (standardized mean difference of -1.47), and fear (mean difference of -1.25) when using VR, suggesting it can be a valuable tool in managing the psychological and physical discomfort of young cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality for pain and anxiety of pediatric oncology patients: A systematic review and meta-analysis. Cheng, Z., Yu, S., Zhang, W., et al.[2022]

Virtual reality (VR) and interactive computer play have been effectively used in pediatric rehabilitation for over 15 years, providing engaging and realistic environments that promote active learning and motor practice.

These technologies enhance neuroplasticity and learning in children with neurological disorders by allowing for repetitive motor and sensory practice, which is crucial for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of virtual reality for cerebral palsy management. Weiss, PL., Tirosh, E., Fehlings, D.[2015]

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 17 studies involving 799 cancer patients found that virtual reality (VR) significantly improved pain, anxiety, upper extremity function, and quality of life after intervention, indicating its efficacy in cancer rehabilitation.

VR not only alleviated physical and psychological symptoms but also showed positive effects on cognitive function, suggesting it can be a valuable addition to comprehensive cancer rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of virtual reality on physical, cognitive, and psychological outcomes in cancer rehabilitation: a systematic review and meta-analysis. Hao, J., Li, Y., Swanson, R., et al.[2023]

The Movement Rating Instrument for Virtual Reality Game Play (MRI-VRGP) was developed to quantify movements during virtual reality gaming, showing excellent reliability for many movement types, particularly for upper extremity far reach and jumping movements.

The study involved 176 gameplay sessions from 11 children (7 typically developing and 4 with cerebral palsy), and while the instrument showed strong reliability for some movements, issues like video quality and rater interpretation need to be addressed for improved accuracy in future assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Reliability Evaluation of the Movement Rating Instrument for Virtual Reality Video Game Play. Levac, D., Nawrotek, J., Deschenes, E., et al.[2020]

In a pilot study involving 12 critically ill children in a Pediatric Critical Care Unit, virtual reality exercise using Nintendo Wii™ Boxing was found to be safe, with no adverse events reported during the intervention.

While the VR exercise increased upper limb activity compared to daily activity, challenges in feasibility were noted, as only 8 participants completed the study, indicating potential barriers to implementation in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Wii-Hab" in critically ill children: a pilot trial. Abdulsatar, F., Walker, RG., Timmons, BW., et al.[2022]

References

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

Virtual reality for pain and anxiety of pediatric oncology patients: A systematic review and meta-analysis. [2022]

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

Role of virtual reality for cerebral palsy management. [2015]

3. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Meta-Analysis of the Efficacy of Virtual Reality-Based Interventions in Cancer-Related Symptom Management. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

Effects of virtual reality on physical, cognitive, and psychological outcomes in cancer rehabilitation: a systematic review and meta-analysis. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Development and Reliability Evaluation of the Movement Rating Instrument for Virtual Reality Video Game Play. [2020]

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

Virtual reality and interactive digital game technology: new tools to address obesity and diabetes. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

"Wii-Hab" in critically ill children: a pilot trial. [2022]

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

Acute Effects of Virtual Reality Exercise Biking on College Students' Physical Responses. [2023]

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

Active video gaming improves body coordination in survivors of childhood brain tumours. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Exergames: the role of ergonomics and design in helping to control childhood obesity through physical and functional exercise program. [2017]