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

Abdominal Pain Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100487
• Other study ID #: H-39390
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: September 2018

Study information

• Verified date: September 2023
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Pain
• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Somatoform Disorders

Intervention

Device:
• Apple iPod Shuffle
One session at least 5 days a week for a total of 8 weeks

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in abdominal pain symptoms	Abdominal Pain Index	Change from Baseline to 8 weeks post-treatment
Secondary	Improvement in health-related quality of life	Pediatric Quality of Life Inventory (Peds QL) Questionnaire	Change from Baseline to 8 weeks post-treatment
Secondary	Change in Psychosocial Distress	Behavior Assessment System for Children (BASC 3) Questionnaire	Change from Baseline to 8 weeks post-treatment
Secondary	Adherence to Intervention	Count of Number of Sessions Played	8 weeks after treatment