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

Not Applicable

Completed

• Conditions: Functional Gastrointestinal Disorders; Abdominal Pain
• Interventions: Device: Apple iPod Shuffle

• Registration Number: NCT03100487
• Lead Sponsor: Baylor College of Medicine

Brief 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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2017-01-19
• Study First Submitted QC: 2017-03-29
• Study First Posted: 2017-04-04
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-17
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Children who meet criteria for a functional gastrointestinal pain disorder.
2. Children who manage their abdominal pain in the primary care setting.

Exclusion Criteria

1. 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.
2. Children with an intellectual disability which would hamper their ability to communicate with study staff about their pain and complete study questionnaires.
3. Children who have presented to a gastroenterologist for abdominal pain management
4. Children who have previously used deep breathing exercises or guided imagery to manage their abdominal pain.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Audio Record Guided Imagery (ARGI)	Apple iPod Shuffle	The audio recorded guided imagery sessions (treatment) will be delivered through a digital audio player (Apple iPod Shuffle).
Deep Breathing Exercises	Apple iPod Shuffle	The deep breathing exercises (control) will be delivered through a digital audio player (Apple iPod Shuffle).

Primary Outcome Measures

Name	Time	Method
Change in abdominal pain symptoms	Change from Baseline to 8 weeks post-treatment	Abdominal Pain Index

Secondary Outcome Measures

Name	Time	Method
Change in Psychosocial Distress	Change from Baseline to 8 weeks post-treatment	Behavior Assessment System for Children (BASC 3) Questionnaire
Improvement in health-related quality of life	Change from Baseline to 8 weeks post-treatment	Pediatric Quality of Life Inventory (Peds QL) Questionnaire
Adherence to Intervention	8 weeks after treatment	Count of Number of Sessions Played

Trial Locations

Locations (1)

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States