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

NCT07222943 | Not Yet Recruiting DMC

• 1 other identifier: H-58306
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

abdominal pain; irritable bowel syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Abdominal Pain Frequency

  Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment

• Anxiety

  Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment

• Anxiety

  Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment

• Depression

  Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment

• Depression

  Baseline, Post-intervention (immediately after 8-week intervention), and 3-months Post-Treatment

Study Arms (1)

Treatment

EXPERIMENTAL

Participants randomized to the Immediate Treatment arm will receive immediate access to the guided imagery therapy mobile application intervention.

Behavioral: Guided Imagery Therapy

Interventions

Guided Imagery Therapy BEHAVIORAL

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.

Treatment

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (2)

Baylor College of Medicine/Texas Children's Hospital

Austin, Texas, 78759, United States

Location

Baylor College of Medicine / Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Gastrointestinal Diseases; Digestive System Diseases; Pain; Abdominal Pain

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Central Study Contacts

Hollier, MD

CONTACT

832-824-3814; GITgoStudy@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Qualified participants will be given access to the mobile app intervention for eight weeks. At the end of the eight weeks, outcome measures will be reassessed through an abdominal pain and stooling diary and other surveys. we will also assess these same outcomes 3 months -post-treatment.

Study Record Dates

• First Submitted: October 26, 2025
• First Posted: October 30, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: October 30, 2025

Record last verified: 2025-10

Locations

US (2)