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

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03100487
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 75
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Pain; Functional Gastrointestinal Disorders	Device: Apple iPod Shuffle	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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)
• Actual Study Start Date: Aug 1, 2016
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Audio Record Guided Imagery (ARGI) The audio recorded guided imagery sessions (treatment) will be delivered through a digital audio player (Apple iPod Shuffle).	Device: Apple iPod Shuffle; One session at least 5 days a week for a total of 8 weeks
Experimental: Deep Breathing Exercises The deep breathing exercises (control) will be delivered through a digital audio player (Apple iPod Shuffle).	Device: Apple iPod Shuffle; One session at least 5 days a week for a total of 8 weeks

Outcome Measures

Primary Outcome Measures

1. Change in abdominal pain symptoms [Change from Baseline to 8 weeks post-treatment]

   Abdominal Pain Index

Secondary Outcome Measures

1. Improvement in health-related quality of life [Change from Baseline to 8 weeks post-treatment]

   Pediatric Quality of Life Inventory (Peds QL) Questionnaire

2. Change in Psychosocial Distress [Change from Baseline to 8 weeks post-treatment]

   Behavior Assessment System for Children (BASC 3) Questionnaire

3. Adherence to Intervention [8 weeks after treatment]

   Count of Number of Sessions Played

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Children's Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

• Baylor College of Medicine

Investigators

• Principal Investigator: John M Hollier, MD, Baylor College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John Hollier, Assistant Professor, Pediatrics-Gastroenterology, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT03100487
• Other Study ID Numbers: H-39390
• First Posted: Apr 4, 2017
• Last Update Posted: Apr 4, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Abdominal Pain; Somatoform Disorders

Study Results

No Results Posted as of Apr 4, 2022