Efficacy of Remote Audio Recorded Guided Imagery vs Deep Breathing Exercises on Primary Pediatric Care Patients With Functional Gastrointestinal Pain Disorders (TCH Pediatric Pilot Award)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in abdominal pain symptoms
研究概览
简要总结
The purpose of this study is to:
- Determine if audio recorded guided imagery vs deep breathing exercises delivered via a digital media player improves abdominal pain symptoms in children with functional gastrointestinal pain disorders managed in the primary care setting.
- Determine if audio recorded guided imagery and deep breathing exercises delivered via a digital media player improves psychosocial distress in children affected by functional gastrointestinal pain disorders managed in the primary care setting.
The possibility of treating functional gastrointestinal pain disorders using remotely delivered psychosocial therapies has the potential to treat many children affected by functional gastrointestinal pain disorders in a cost-effective manner. This study will provide insight into how well these patients in the primary care could benefit from such interventions.
详细描述
Children managed in primary care with a functional gastrointestinal pain disorder will be recruited and studied for this trial. After participants are deemed eligible, they will complete multiple questionnaires and then be randomly assigned (like a flip of a coin) to either guided imagery or deep breathing exercises delivered via a digital media player. Participants will be instructed to listen to the tracks at least 5 days per week for an 8 week intervention period.
At week 3 of the intervention period, the participant will complete another 2 week pain and stool diary.
At week 7 of the intervention period, the participant will complete another 2 week pain and stool dairy. After this diary is completed, the participant will again complete multiple questionnaires for their final visit.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who meet criteria for a functional gastrointestinal pain disorder.
- •Children who manage their abdominal pain in the primary care setting.
排除标准
- •Children who have other comorbidities that are associated with chronic abdominal pain including abdominal surgery and other medical diagnoses that can cause chronic abdominal pain.
- •Children with an intellectual disability which would hamper their ability to communicate with study staff about their pain and complete study questionnaires.
- •Children who have presented to a gastroenterologist for abdominal pain management
- •Children who have previously used deep breathing exercises or guided imagery to manage their abdominal pain.
结局指标
主要结局
Change in abdominal pain symptoms
时间窗: Change from Baseline to 8 weeks post-treatment
Abdominal Pain Index
次要结局
- Improvement in health-related quality of life(Change from Baseline to 8 weeks post-treatment)
- Change in Psychosocial Distress(Change from Baseline to 8 weeks post-treatment)
- Adherence to Intervention(8 weeks after treatment)
研究者
John Hollier
Assistant Professor, Pediatrics-Gastroenterology
Baylor College of Medicine