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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Functional Dyspepsia; Irritable Bowel Syndrome (IBS); Gastrointestinal and Digestive Disorder; Abdominal Pain/ Discomfort; Functional Abdominal Pain Disorders; Functional Gastrointestinal Disorders (FGIDs)
• Intervention / Treatment: Behavioral: Guided Imagery Therapy

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hollier, MD; Phone Number: 832-824-3814; Email: GITgoStudy@bcm.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78759
      • Baylor College of Medicine/Texas Children's Hospital
      • Contact: Hollier, MD; Phone Number: 832-824-3814; Email: jmhollie@bcm.edu
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine / Texas Children's Hospital
      • Contact: Hollier, MD; Phone Number: 832-824-3814; Email: jmhollie@bcm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Participants randomized to the Immediate Treatment arm will receive immediate access to the guided imagery therapy mobile application intervention.	Behavioral: Guided Imagery Therapy; Participants will be asked to listen to a pre-recorded, 10 to 15 minute guided imagery therapy (GIT) sessions via mobile application 5 out of 7 days per week for 8 weeks in addition to their usual care for their abdominal pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal Pain Intensity	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	Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: October 26, 2025
• First Submitted That Met QC Criteria: October 28, 2025
• First Posted (Estimated): October 30, 2025

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 28, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: abdominal pain; irritable bowel syndrome
• Additional Relevant MeSH Terms: Neurologic Manifestations; Signs and Symptoms, Digestive; Intestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Irritable Bowel Syndrome; Gastrointestinal Diseases; Digestive System Diseases; Abdominal Pain
• Other Study ID Numbers: H-58306

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No