Virtual Reality Gaming for Pediatric Cancer

Overseen By Raven Young, BS

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Alabama at Birmingham

Disqualifiers: Blindness, Deafness, Motion sickness, others

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

Compensation: Varies

Number of Visits: Unknown

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a virtual reality gaming program, called Virtual Reality Exercise and Mindfulness Gaming, can aid children with cancer during recovery. The program, which combines mindfulness and exercise activities, lasts for 8 weeks and begins either in the hospital or after the child returns home. The goal is to determine if this approach supports rehabilitation. Children over 7 who stay in the hospital for at least two weeks and have a caregiver to assist them may be eligible to participate. As a Phase 1 trial, the research focuses on understanding how this new treatment works in people, offering participants the chance to be among the first to experience its potential benefits.

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 prior data suggests that this virtual reality gaming program is safe for pediatric cancer patients?

Research has shown that virtual reality (VR) games for exercise and mindfulness are generally easy for kids to use. These games have improved both physical and mental health in children with cancer. So far, studies on similar VR programs have not reported any serious side effects, indicating that most kids can play these VR games without major issues. As this is a Phase 1 trial, the researchers are primarily testing the program with a small group to ensure its safety and to identify any unexpected problems. If the VR program proves safe and helpful, it could offer a fun way to support kids during cancer recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) gaming for pediatric cancer patients because it offers a unique, engaging way to support recovery and mental well-being. Unlike traditional treatment options that focus solely on medical interventions like chemotherapy and radiation, VR gaming combines exercise with mindfulness in an immersive experience. This innovative approach could improve physical activity and mental health during and after hospital stays, offering a fun and interactive way to manage stress and anxiety. The immediacy and engaging nature of VR could make it appealing to young patients, potentially enhancing their overall treatment experience.

What evidence suggests that virtual reality exercise and mindfulness gaming is effective for pediatric cancer rehabilitation?

Research has shown that virtual reality games can improve the physical and mental health of children with cancer. In this trial, participants in the "Immediate Start" arm will begin the Virtual Reality Exercise and Mindfulness Gaming program in the hospital and continue for 8 weeks after discharge. Meanwhile, those in the "Waitlist Control" arm will start the same 8-week intervention after an 8-week delay post-discharge. Studies have found that these games, which focus on exercise and relaxation, can increase activity levels and reduce stress in children. The games are designed to encourage movement and teach relaxation techniques. Early results suggest that this approach can make exercise more enjoyable and aid in recovery. While researchers continue to explore this idea, initial findings are promising for helping young patients manage cancer treatment. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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

I am older than 7 years.

Exclusion Criteria

Complete blindness or deafness

Susceptible to motion sickness in virtual reality

I cannot use hand-held controllers.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Exercise and Mindfulness Gaming

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

Virtual reality (VR) technologies are evolving in clinical settings, showing promise in creating engaging environments for various health conditions, particularly through interactive digital games and exergaming.

Current exergames can increase energy expenditure significantly compared to sedentary activities, but they do not yet provide the intensity needed to match actual sports or meet recommended exercise levels for children, suggesting they should complement rather than replace traditional exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality and interactive digital game technology: new tools to address obesity and diabetes. Skip Rizzo, A., Lange, B., Suma, EA., et al.[2021]

Active video gaming (AVG) was found to be a feasible and enjoyable way to promote regular physical exercise in children aged 7-17 who are survivors of brain tumors, with participants engaging in AVG for an average of 47 minutes on 72% of days.

The study showed a significant improvement in Body Coordination scores by 15% after 10-12 weeks of AVG, indicating that this intervention can enhance physical functioning in childhood brain tumor survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active video gaming improves body coordination in survivors of childhood brain tumours. Sabel, M., Sjölund, A., Broeren, J., et al.[2022]

Using a VirZoom VR exercise bike (vBike) led to significantly higher physical activity levels, measured by pedal revolution counts, compared to both an exergaming bike (eBike) and a traditional stationary bike (tBike) in a study with 48 college students.

Participants reported lower perceived exertion while using the vBike compared to the tBike, suggesting that VR exercise may provide a more enjoyable and less intense workout experience, which could encourage more people to engage in physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute Effects of Virtual Reality Exercise Biking on College Students' Physical Responses. Zeng, N., Liu, W., Pope, ZC., et al.[2023]

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]

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]

Exergames, which combine physical activity with gaming, are emerging as a promising tool for improving cognitive skills and motor abilities in children, particularly in the context of addressing childhood obesity.

The review highlights the potential of virtual technologies, like Nintendo Wii and X-Box 360, to create engaging and low-cost solutions for promoting physical activity and enhancing physiotherapy practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exergames: the role of ergonomics and design in helping to control childhood obesity through physical and functional exercise program. Barros, M., Neves, A., Correia, W., et al.[2017]

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]

Virtual reality (VR) interventions have been shown to significantly reduce symptoms of anxiety, depression, pain, and fatigue in cancer patients, based on a meta-analysis of 6 studies.

The findings suggest that while VR is effective for managing acute symptoms during cancer treatment, further research is needed to explore its benefits for long-term side effects in cancer survivorship care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-Analysis of the Efficacy of Virtual Reality-Based Interventions in Cancer-Related Symptom Management. Zeng, Y., Zhang, JE., Cheng, ASK., et al.[2020]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39714090/

Extended Reality Gaming for Exercise and Mindfulness ...

This trial tests an accessible remote program for improving both physical and mental health among pediatric patients with cancer.

2.

researchprotocols.org

researchprotocols.org/2024/1/e64879

Extended Reality Gaming for Exercise and Mindfulness ...

This trial tests an accessible remote program for improving both physical and mental health among pediatric patients with cancer.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06298357

Virtual Reality Gaming for Exercise and Mindfulness ...

This study will explore the potential benefits of a virtual reality gaming program that focuses on mindfulness and exercise among pediatric cancer ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11704644/

Extended Reality Gaming for Exercise and Mindfulness ...

This phase I, pilot, feasibility randomized controlled trial aims to investigate the potential effects of a 14-week ER program on physical activity ...

5.

researchgate.net

researchgate.net/publication/384436770_Extended_reality_gaming_for_exercise_and_mindfulness_throughout_pediatric_cancer_rehabilitation_randomized_controlled_trial_protocol_Preprint

(PDF) Extended reality gaming for exercise and ...

Extended reality gaming for exercise and mindfulness throughout pediatric cancer rehabilitation: randomized controlled trial protocol (Preprint). July 2024 ...