Efficacy of Audio Recorded Guided Imagery vs Deep Breathing Exercises on Functional Gastrointestinal Pain Disorders
Primary Purpose
Abdominal Pain, Functional Gastrointestinal Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apple iPod Shuffle
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Pain
Eligibility Criteria
Inclusion Criteria:
- Children who meet criteria for a functional gastrointestinal pain disorder.
- Children who manage their abdominal pain in the primary care setting.
Exclusion Criteria:
- 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.
Sites / Locations
- Texas Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Audio Record Guided Imagery (ARGI)
Deep Breathing Exercises
Arm Description
The audio recorded guided imagery sessions (treatment) will be delivered through a digital audio player (Apple iPod Shuffle).
The deep breathing exercises (control) will be delivered through a digital audio player (Apple iPod Shuffle).
Outcomes
Primary Outcome Measures
Change in abdominal pain symptoms
Abdominal Pain Index
Secondary Outcome Measures
Improvement in health-related quality of life
Pediatric Quality of Life Inventory (Peds QL) Questionnaire
Change in Psychosocial Distress
Behavior Assessment System for Children (BASC 3) Questionnaire
Adherence to Intervention
Count of Number of Sessions Played
Full Information
NCT ID
NCT03100487
First Posted
January 19, 2017
Last Updated
September 17, 2023
Sponsor
Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03100487
Brief Title
Efficacy of Audio Recorded Guided Imagery vs Deep Breathing Exercises on Functional Gastrointestinal Pain Disorders
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain, Functional Gastrointestinal Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Audio Record Guided Imagery (ARGI)
Arm Type
Experimental
Arm Description
The audio recorded guided imagery sessions (treatment) will be delivered through a digital audio player (Apple iPod Shuffle).
Arm Title
Deep Breathing Exercises
Arm Type
Experimental
Arm Description
The deep breathing exercises (control) will be delivered through a digital audio player (Apple iPod Shuffle).
Intervention Type
Device
Intervention Name(s)
Apple iPod Shuffle
Intervention Description
One session at least 5 days a week for a total of 8 weeks
Primary Outcome Measure Information:
Title
Change in abdominal pain symptoms
Description
Abdominal Pain Index
Time Frame
Change from Baseline to 8 weeks post-treatment
Secondary Outcome Measure Information:
Title
Improvement in health-related quality of life
Description
Pediatric Quality of Life Inventory (Peds QL) Questionnaire
Time Frame
Change from Baseline to 8 weeks post-treatment
Title
Change in Psychosocial Distress
Description
Behavior Assessment System for Children (BASC 3) Questionnaire
Time Frame
Change from Baseline to 8 weeks post-treatment
Title
Adherence to Intervention
Description
Count of Number of Sessions Played
Time Frame
8 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children who meet criteria for a functional gastrointestinal pain disorder.
Children who manage their abdominal pain in the primary care setting.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John M Hollier, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Audio Recorded Guided Imagery vs Deep Breathing Exercises on Functional Gastrointestinal Pain Disorders
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