Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation Patients: Pilot Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Physical activity
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>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
排除标准
- •complete blindness or deafness
- •inability to operate the hand-held controllers
- •susceptible to motion sickness in virtual reality
- •inability to communicate in English
研究组 & 干预措施
Immediate Start
Program starts in the hospital and lasts for 8 weeks after hospital discharge.
干预措施: Immediate Start - Virtual Reality (Behavioral)
Waitlist Control
After 8 weeks after hospital discharge, these participants start the 8 week intervention.
干预措施: Delayed Start - Virtual Reality (Behavioral)
结局指标
主要结局
Physical activity
时间窗: 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).
次要结局
- Minutes of gameplay(Hospital discharge (approximately week 4), Intervention week 4, and Intervention Week 8.)
- Global Health(Week 0, ~Week 2 (Post-Transplant), ~Week 4 (hospital discharge), Intervention or Wait Period Week 4, Intervention or Wait Period Week 8.)
- Forced Expiratory Volume in the first second (FEV1)(Week 0, ~Week 2 (Post-Transplant), ~Week 4 (hospital discharge), Intervention or Wait Period Week 4, Intervention or Wait Period Week 8.)
研究者
Byron Lai
Assistant Professor
University of Alabama at Birmingham