Efficacy of Guided Imagery Therapy Mobile Application for Functional Abdominal Pain

Baylor College of Medicine

Status: Completed

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

Treatments: Behavioral: Guided Imagery Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06653647

K23DK120928 (U.S. NIH Grant/Contract)

H-51406

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 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.

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, 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)

Enrollment: 4 patients

Sex: All

Ages: 7 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Immediate Treatment

Active Comparator 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

Delayed Treatment

Other group

Description:

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.

Treatment:

Behavioral: Guided Imagery Therapy