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OpenTrials
Completed

NCT Number: NCT06298357

Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation

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).

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Key information

Conditions

Pediatric Cancer Neoplasms

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate Start - Virtual Reality

Behavioral

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.

Delayed Start - Virtual Reality

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Minutes of gameplay

    Time frame: Hospital discharge (approximately week 4), Intervention week 4, and Intervention Week 8.

    Minutes of gameplay measured by the Meta Quest headset.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation Patients: Pilot Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 7, 2024
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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