COMPLETED

Efficacy of Guided Imagery Therapy Mobile Application for Functional Abdominal Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot Efficacy of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children

Quick Facts

Study Start:2025-07-18
Study Completion:2025-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06653647

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Texas Children's Pediatrics patients 7 to 12 years old at enrollment
  2. * A Rome IV Functional Abdominal Pain Disorder as defined by a 2-week abdominal pain and stooling diary
  3. * 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.
  1. * Prior participation in principal investigator's related feasibility or usability study
  2. * Previous abdominal surgeries
  3. * Co-morbid conditions associated with abdominal pain (e.g., cystic fibrosis)
  4. * Autism
  5. * Significant development delay
  6. * Psychosis
  7. * Prior experience with cognitive behavioral therapy or guided imagery therapy to treat chronic abdominal pain
  8. * Alarm symptoms that warrant further medical evaluation (e.g., blood in stool)

Contacts and Locations

Principal Investigator

John M Hollier, MD, MS, MPH
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Baylor College of Medicine

  • John M Hollier, MD, MS, MPH, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-18
Study Completion Date2025-11-30

Study Record Updates

Study Start Date2025-07-18
Study Completion Date2025-11-30

Terms related to this study

Keywords Provided by Researchers

  • abdominal pain
  • irritable bowel syndrome
  • recurrent abdominal pain

Additional Relevant MeSH Terms

  • Functional Abdominal Pain Disorders
  • Irritable Bowel Syndrome (IBS)
  • Functional Gastrointestinal Disorders
  • Functional Colonic Disease
  • Gastrointestinal Disease
  • Digestive System Diseases
  • Neurological Manifestations
  • Signs and Symptoms, Digestive
  • Pain
  • Abdominal Pain/ Discomfort