Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children

Not Applicable

Not yet recruiting

• Conditions: Functional Abdominal Pain Disorders; Pain; Irritable Bowel Syndrome (IBS); Abdominal Pain/ Discomfort; Functional Gastrointestinal Disorders (FGIDs); Gastrointestinal and Digestive Disorder; Functional Dyspepsia

• Registration Number: NCT07222943
• Lead Sponsor: Baylor College of Medicine

Brief Summary

Chronic abdominal pain is common among children, and the majority of cases are attributed to functional abdominal pain disorders. One approach to treating these disorders is by using psychological therapies. This clinical trial aims to see how well pre-recorded guided imagery therapy sessions help children's abdominal pain when delivered via a mobile application (app) on a smartphone or tablet.

Participants will complete a baseline abdominal pain and stooling diary to determine eligibility, as well as other surveys. Eligible participants will be given access to the guided imagery therapy mobile application.

This intervention asks participants to listen to a 10- to 15-minute GIT session 5 out of 7 days per week for 8 weeks, in addition to their usual care for their abdominal pain. Then, participants will complete another abdominal pain and stooling diary, along with other psychometric surveys, at the end of this intervention period. Participants will also collect another diary and surveys 3 months post-treatment.

Detailed Description

After fully disclosing the study design, intervention options, randomization scheme, and potential side effects of the interventions, caregivers and their children will document their respective informed consent and assent electronically. REDCap is a secure web application designed for surveys and databases. All data captured through REDCap will be encrypted and transmitted securely to HIPAA-compliant institutional servers for storage.

Participants and their caregivers will complete the following surveys at baseline, immediately post-therapy (8 weeks after baseline), and 3 months post-treatment through REDCap:

* 2-week Abdominal Pain and Stooling Diary

* Children's Somatic Symptoms Inventory (child self-report and parent proxy-report)

* Pain Catastrophizing Scale - Child Version

* Pain Catastrophizing Scale - Parent Version

* Pediatric Quality of Life Inventory 4.0 Generic Core (child self-report and parent proxy-report)

* Behavior Assessment System for Children 3rd Ed (child self-report and parent proxy-report)

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-26
• Study First Submitted QC: 2025-10-28
• Last Update Submitted: 2025-10-28
• Study First Posted: 2025-10-30
• Last Update Posted: 2025-10-30
• Study Start: 2025-12-01
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Texas Children's Pediatrics patients 7 to 12 years old at enrollment
• A Rome IV Functional Abdominal Pain Disorder as defined by a 2-week abdominal pain and stooling diary
• Both children and their primary caregivers must be able to read and communicate in English proficiently to understand the intervention's audio therapy sessions and psychometric instruments.

Exclusion Criteria

• Previous abdominal surgeries
• Co-morbid conditions associated with abdominal pain (e.g., cystic fibrosis)
• Autism
• Significant development delay
• Psychosis
• Prior experience with cognitive behavioral therapy or guided imagery therapy to treat chronic abdominal pain
• Alarm symptoms that warrant further medical evaluation (e.g., blood in stool)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Abdominal Pain Intensity	Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment	Average daily abdominal pain severity measured on a 0-10 (10 is most severe) ordinal scale from a self-report 2-week abdominal pain diary

Secondary Outcome Measures

Name	Time	Method
Abdominal Pain Frequency	Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment	Average number of abdominal pain episodes per day from a self-report 2-week abdominal pain diary
Anxiety	Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment	Behavior Assessment System for Children, third edition, parent proxy-report Anxiety Scale, t score ranges from 20 to 120, higher scores are worse
Health-Related Quality of Life	Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment	Pediatric Quality of Life Inventory Generic Core Scales 4.0 parent-proxy report, raw score ranges from 0 to 100, higher scores are better
Depression	Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment	Behavior Assessment System for Children, third edition, parent-proxy report Depression scale, t scores ranges from 20 to 120, higher scores are worse
Somatization	Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment	Children's Somatic Symptoms Inventory parent-proxy report, raw score ranges from 0 to 96, higher scores are worse
Pain Catastrophizing Thoughts	Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment	Pain Catastrophizing Scale - Parent Version, raw score range from 0 to 52, higher scores are worse

Trial Locations

Locations (2)

Baylor College of Medicine/Texas Children's Hospital; 🇺🇸 Austin, Texas, United States

Baylor College of Medicine / Texas Children's Hospital; 🇺🇸 Houston, Texas, United States