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Trial Title:
Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation
NCT ID:
NCT06298357
Condition:
Pediatric Cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Intervention model description:
There will be 2 parallel groups, immediate start group and waitlist control group. Once
control participants finish the wait period (8 weeks), they will start the intervention
(8 weeks). Participants in the immediate start group will start exercise and mindfulness
in the hospital and continue the program for 8 weeks outside of the hospital.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Immediate Start - Virtual Reality
Description:
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.
Arm group label:
Immediate Start
Intervention type:
Behavioral
Intervention name:
Delayed Start - Virtual Reality
Description:
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.
Arm group label:
Waitlist Control
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).
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
8 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Children's Hospital of Alabama
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Status:
Recruiting
Contact:
Last name:
Byron Lai, PhD
Phone:
205-200-1724
Email:
byronlai@uab.edu
Start date:
June 27, 2024
Completion date:
March 31, 2026
Lead sponsor:
Agency:
University of Alabama at Birmingham
Agency class:
Other
Source:
University of Alabama at Birmingham
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06298357