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

Baylor College of Medicine

Status: Not yet enrolling

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

Treatments: Behavioral: Guided Imagery Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07222943

H-58306

Details and patient eligibility

About

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.

Full 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)

Enrollment: 36 estimated patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Treatment

Experimental group

Description:

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

Treatment:

Behavioral: Guided Imagery Therapy