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

September 17, 2023 updated by: John Hollier, Baylor College of Medicine

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)

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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).
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).
One session at least 5 days a week for a total of 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in abdominal pain symptoms
Time Frame: Change from Baseline to 8 weeks post-treatment
Abdominal Pain Index
Change from Baseline to 8 weeks post-treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

January 19, 2017

First Submitted That Met QC Criteria

March 29, 2017

First Posted (Actual)

April 4, 2017

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 17, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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