NCT03100487

Efficacy of Audio Recorded Guided Imagery vs Deep Breathing Exercises on Functional Gastrointestinal Pain Disorders

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to: 1. 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. 2. 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.

Detailed description

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.

Conditions

• Abdominal Pain
• Functional Gastrointestinal Disorders

Interventions

Type	Name	Description
DEVICE	Apple iPod Shuffle	One session at least 5 days a week for a total of 8 weeks

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2017-04-04
• Last updated: 2023-09-21

Locations

1 site across 1 country: United States