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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Abdominal Pain, Functional Gastrointestinal Disorders

Intervention / Treatment
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* Device: Apple iPod Shuffle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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