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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
First received
Last updated
Start date July 1, 2024
Est. completion date March 31, 2026

Study information

Verified date May 2024
Source University of Alabama at Birmingham
Contact Byron Lai, PhD
Phone 205.638.9790
Email blai@uabmc.edu
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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