Efficacy of Guided Imagery Therapy Mobile Application for Functional Abdominal Pain

Pilot Efficacy 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 and other surveys. Participants who qualify will be placed in one of two groups by chance:

• Immediate Treatment Group
• Delayed Treatment Group

After randomization, the Immediate Treatment Group will get immediate access to the guided imagery therapy (GIT) mobile app intervention. This intervention asks participants to listen to a 10- to 15-minute GIT session 5 out 7 days weekly for 8 weeks in addition to their usual care for their abdominal pain. Then, participants will complete another abdominal pain and stooling diary and other psychometric surveys at the end of this intervention period.

After randomization, the Delayed Treatment group will be observed as they wait 8 weeks without app access. During this phase, these participants will continue to treat their abdominal pain in their usual fashion. After the end of this waiting period, participants will complete another abdominal pain and stooling diary and psychometric surveys again before gaining access to the GIT mobile app intervention. As noted previously, the mobile app intervention will ask participants to listen to a 10- to 15-minute GIT session 5 out of 7 days weekly for 8 weeks in addition to their usual care for their abdominal pain. Another abdominal pain and stooling diary and other psychometric surveys will be collected at the end of this app intervention.

Study Overview

• Status: Completed
• Conditions: Digestive System Diseases; Pain; Signs and Symptoms, Digestive; Functional Gastrointestinal Disorders; Gastrointestinal Disease; Irritable Bowel Syndrome (IBS); Neurological Manifestations; Functional Colonic Disease; Abdominal Pain/ Discomfort; Functional Abdominal Pain Disorders
• 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, second baseline phase (delayed treatment group only 8 weeks after baseline), and immediately post-therapy (delayed treatment group 16 weeks after baseline and immediate treatment group 8 weeks after baseline) 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 (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine / Texas Children's Hospital

Participation Criteria

Eligibility Criteria

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

Description

Study staff will enroll children with functional abdominal pain disorders and their primary caregiver for this study.

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:

• Prior participation in principal investigator's related feasibility or usability study
• 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: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Immediate 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) session via mobile application 5 out of 7 days per week for 8 weeks in addition to their usual care for their abdominal pain.
Other: Delayed Treatment; Participants randomized to the Delayed Treatment arm will be placed on waitlist status and will not have any intervention from weeks 3 to 10. Participants will continue their usual care for their abdominal pain during this time. Then, this study arm will cross over to the guided imagery therapy mobile application intervention from weeks 11 to 18.	Behavioral: Guided Imagery Therapy; Participants will be asked to listen to a pre-recorded, 10 to 15 minute guided imagery therapy (GIT) session 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 Frequency	Average number of abdominal pain episodes per day from a self-report 2-week abdominal pain diary	Baseline (both groups), Second baseline (delayed treatment group only, 8 weeks after baseline), and Post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline)

Secondary 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 (both groups), Second baseline (delayed treatment group only, 8 weeks after baseline), and Post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline)
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 (both groups), Second baseline (delayed treatment group only, 8 weeks after baseline), and Post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline)
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 (both groups), Second baseline (delayed treatment group only, 8 weeks after baseline), and Post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline)
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 (both groups), Second baseline (delayed treatment group only, 8 weeks after baseline), and Post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline)
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 (both groups), Second baseline (delayed treatment group only, 8 weeks after baseline), and Post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline)
Somatization	Children's Somatic Symptoms Inventory child self-report, raw score ranges from 0 to 96, higher scores are worse	Baseline (both groups), Second baseline (delayed treatment group only, 8 weeks after baseline), and Post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline)
Somatization	Children's Somatic Symptoms Inventory parent-proxy report, raw score ranges from 0 to 96, higher scores are worse	Baseline (both groups), Second baseline (delayed treatment group only, 8 weeks after baseline), and Post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline)
Pain Catastrophizing Thoughts	Pain Catastrophizing Scale - Child Version, raw score ranges from 0 to 52, higher scores are worse	Baseline (both groups), Second baseline (delayed treatment group only, 8 weeks after baseline), and Post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline)
Pain Catastrophizing Thoughts	Pain Catastrophizing Scale - Parent Version, raw score range from 0 to 52, higher scores are worse	Baseline (both groups), Second baseline (delayed treatment group only, 8 weeks after baseline), and Post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline)
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 (both groups), Second baseline (delayed treatment group only, 8 weeks after baseline), and Post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline)
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 (both groups), Second baseline (delayed treatment group only, 8 weeks after baseline), and Post-intervention (delayed group 16 weeks after initial baseline, immediate group 8 weeks after baseline)

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: John M Hollier, MD, MS, MPH, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2025
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: abdominal pain; irritable bowel syndrome; recurrent abdominal pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Intestinal Diseases; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Irritable Bowel Syndrome; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases, Functional; Neurologic Manifestations; Abdominal Pain; Signs and Symptoms, Digestive
• Other Study ID Numbers: H-51406; K23DK120928 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No