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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 12
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
Baylor College of Medicine / Texas Children's Hospital
RECRUITING
Houston
Contact Information
Primary
Laurel Cavallo
GITgoStudy@bcm.edu
713-581-0370
Time Frame
Start Date: 2025-07-18
Estimated Completion Date: 2025-11
Participants
Target number of participants: 52
Treatments
Active_comparator: Immediate Treatment
Participants randomized to the Immediate Treatment arm will receive immediate access to the guided imagery therapy mobile application intervention.
Other: Delayed Treatment
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Baylor College of Medicine

This content was sourced from clinicaltrials.gov