CompletedNot Applicable

Efficacy of Guided Imagery Therapy Mobile Application for Functional Abdominal Pain

United States4 participantsStarted 2025-07-18

Plain-language 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 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.

Who can participate

Age range

7 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Abdominal Pain Frequency

Timeframe: 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)

Trial details

NCT IDNCT06653647

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-30

View on ClinicalTrials.gov More Functional Abdominal Pain Disorders trials