Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation
March 16, 2026 updated by: Byron Lai, University of Alabama at Birmingham
Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation Patients: Pilot Randomized Controlled 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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- Children's Hospital of Alabama
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- >7 years of age
- medical diagnosis of malignancy or non-malignant condition requiring hematopoietic stem cell transplant or a hospital stay that is anticipated to last for at least 2 weeks
- a caregiver who can assist the child with the study procedures
Exclusion Criteria:
- complete blindness or deafness
- inability to operate the hand-held controllers
- susceptible to motion sickness in virtual reality
- inability to communicate in English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate Start
Program starts in the hospital and lasts for 8 weeks after hospital discharge.
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Participants will use a Meta Quest virtual reality headset and play video games for exercise and mindfulness.
They will start using the headsets in the hospital and then will continue to do so for 8 weeks after hospital discharge.
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Active Comparator: Waitlist Control
After 8 weeks after hospital discharge, these participants start the 8 week intervention.
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Participants will receive usual care in the hospital and outside of the hospital for 8 weeks.
After the 8 week post-discharge period, participants will use a Meta Quest virtual reality headset and play video games for exercise and mindfulness for an 8 week period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity
Time Frame: Daily, starting after consent in the hospital (week 0) and ending after the intervention (intervention week 9)
|
Steps per day measured by a tri-axial accelerometer (Fitbit Flex).
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Daily, starting after consent in the hospital (week 0) and ending after the intervention (intervention week 9)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Minutes of gameplay
Time Frame: Hospital discharge (approximately week 4), Intervention week 4, and Intervention Week 8.
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Minutes of gameplay measured by the Meta Quest headset.
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Hospital discharge (approximately week 4), Intervention week 4, and Intervention Week 8.
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Global Health
Time Frame: Week 0, ~Week 2 (Post-Transplant), ~Week 4 (hospital discharge), Intervention or Wait Period Week 4, Intervention or Wait Period Week 8.
|
National Institutes of Health (NIH) PROMIS Global Health Short Form 7+2 survey.
The scale consists of 7 items that are summarized into a single score of overall health.
Participants respond to items without a recall period on how they would rate their overall health, quality of life, and their physical, mental, and social health, using a 5-point Likert scale with varying response categories.
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Week 0, ~Week 2 (Post-Transplant), ~Week 4 (hospital discharge), Intervention or Wait Period Week 4, Intervention or Wait Period Week 8.
|
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Forced Expiratory Volume in the first second (FEV1)
Time Frame: Week 0, ~Week 2 (Post-Transplant), ~Week 4 (hospital discharge), Intervention or Wait Period Week 4, Intervention or Wait Period Week 8.
|
FEV1 (Liters) by a Spirometer
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Week 0, ~Week 2 (Post-Transplant), ~Week 4 (hospital discharge), Intervention or Wait Period Week 4, Intervention or Wait Period Week 8.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 27, 2024
Primary Completion (Actual)
December 1, 2025
Study Completion (Actual)
March 16, 2026
Study Registration Dates
First Submitted
February 29, 2024
First Submitted That Met QC Criteria
February 29, 2024
First Posted (Actual)
March 7, 2024
Study Record Updates
Last Update Posted (Actual)
March 18, 2026
Last Update Submitted That Met QC Criteria
March 16, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 300012601
- LAIKPRI02012024 (Other Grant/Funding Number: Kaul Pediatric Research Institute Pilot Grant)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.