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

NCT ID: NCT07222943

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-11-30

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)

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Guided Imagery Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

John M Hollier

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Baylor College of Medicine/Texas Children's Hospital

Austin, Texas, United States

Baylor College of Medicine / Texas Children's Hospital

Houston, Texas, United States

Countries

United States

Central Contacts

Hollier, MD

Role: CONTACT

GITgoStudy@bcm.edu

832-824-3814

Facility Contacts

Hollier, MD

Role: primary

jmhollie@bcm.edu

832-824-3814

Hollier, MD

Role: primary

jmhollie@bcm.edu

832-824-3814

Other Identifiers

H-58306

Identifier Type: -

Identifier Source: org_study_id