Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06298357
• Other study ID #: 300012601
• Secondary ID: LAIKPRI02012024
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 1, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: Byron Lai, PhD
• Phone: 205.638.9790
• Email: blai[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• >7 years of age
• medical diagnosis of malignancy or non-malignant condition requiring hematopoietic stem cell transplant
• 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

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Behavioral:
• Immediate Start - Virtual Reality
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
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.

Locations

Country	Name	City	State
United States	Children's Hospital of Alabama	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity	Steps per day measured by a tri-axial accelerometer (Fitbit Flex).	Daily, starting after consent in the hospital (week 0) and ending after the intervention (intervention week 9)
Secondary	Minutes of gameplay	Minutes of gameplay measured by the Meta Quest headset.	Hospital discharge (approximately week 4), Intervention week 4, and Intervention Week 8.
Secondary	Global Health	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.	Week 0, ~Week 2 (Post-Transplant), ~Week 4 (hospital discharge), Intervention or Wait Period Week 4, Intervention or Wait Period Week 8.
Secondary	Forced Expiratory Volume in the first second (FEV1)	FEV1 (Liters) by a Spirometer	Week 0, ~Week 2 (Post-Transplant), ~Week 4 (hospital discharge), Intervention or Wait Period Week 4, Intervention or Wait Period Week 8.