Efficacy of Guided Imagery Therapy Mobile Application for Functional Abdominal Pain

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.

Conditions

• 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

Interventions

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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Baylor College of Medicine

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-18

Primary Completion

2025-11-30

Completion

2025-11-30

Countries

• United States

Study Locations