The Utility of Virtual Reality in the Management of Pediatric Functional Constipation With Pelvic Floor Dysfunction.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction.
研究概览
简要总结
- To determine if the adjunctive use of a Virtual Reality (VR) module on diaphragmatic breathing (DB) can improve the quality of life (QOL) and symptoms of children with functional constipation (FC) with pelvic floor dysfunction (PFD) who are receiving standard of care treatment.
- To assess if a VR module on DB can decrease healthcare utilization for children with FC with PFD.
详细描述
The investigators will assess if the use a Virtual Reality (VR) module on diaphragmatic breathing (DB) can improve quality of life, constipation symptoms, and decrease healthcare utilization for children with functional constipation (FC) with pelvic floor dysfunction (PFD). FC is a common pediatric condition with a high prevalence and $4.25 billion yearly in healthcare expenditures. FC is often complicated with PFD as seen through stool withholding behaviors. Children with FC with PFD are referred to occupational therapy for biofeedback and DB training as standard of care. Occupational therapy uses to teach children with FC with PFD to relax their abdominal muscles, and subsequently their pelvic floor muscles, facilitating a more complete bowel evacuation. VR is a technology currently employed in rehabilitation services, anesthesiology and surgery. VR can provide a fun, immersive environment with a feedback component for children with FC to learn DB effectively and build a positive association with toileting.
The purpose of this study is to examine if a virtual reality module that teaches children diaphragmatic breathing through an immersive game can improve the quality of life and decrease health care utilization for children with functional constipation and pelvic floor dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
Care provider will be blinded to the intervention.
入排标准
- 年龄范围
- 7 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 7 to 21 years old
- •Meets Rome IV criteria for functional constipation and pelvic floor dysfunction
- •Developmentally appropriate to understand verbal instructions
排除标准
- •Co-existing medical conditions that include inflammatory bowel disease, Hirschsprung's Disease, cystic fibrosis, tethered cord, anal stenosis, sacral agenesis, spinal cord anomalies, untreated thyroid disease, untreated celiac disease, neurogenic bowel, cerebral palsy, major bowel surgery.
- •Non-English speaking
研究组 & 干预措施
Virtual reality arm
This arm will receive diaphragmatic breathing teaching by a medical professional and virtual reality module that teaches diaphragmatic breathing. This arm will be sent home with the virtual reality equipment and practice this breathing technique through the virtual reality module for 8 weeks.
干预措施: Oculus go headset/virtual reality headset (Device)
Virtual reality arm
This arm will receive diaphragmatic breathing teaching by a medical professional and virtual reality module that teaches diaphragmatic breathing. This arm will be sent home with the virtual reality equipment and practice this breathing technique through the virtual reality module for 8 weeks.
干预措施: Diaphragmatic breathing (Behavioral)
Control
This arm will receive diaphragmatic breathing teaching by a medical professional only. They will practice this breathing technique with a paper handout of diaphragmatic breathing technique instructions for 8 weeks.
干预措施: Diaphragmatic breathing (Behavioral)
结局指标
主要结局
Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction.
时间窗: Baseline, week 8
This outcome will assess cure of functional constipation and pelvic floor dysfunction.
Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction.
时间窗: Baseline, 1 visit between week 2
This outcome will assess cure of functional constipation and pelvic floor dysfunction.
Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction.
时间窗: Baseline, week 4
This outcome will assess cure of functional constipation and pelvic floor dysfunction.
次要结局
- Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module(Baseline, week 8)
- Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire(Baseline, week 8)
- Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module(Baseline, 1 visit between week 2)
- Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module(Baseline, week 4)
- Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire(Baseline, 1 visit between week 2)
- Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire(Baseline, week 4)
研究者
Ann Ming Yeh
Clinical Associate Professor
Stanford University