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Recruiting
NCT07222943
Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children
Conditions: Functional Abdominal Pain Disorders, Irritable Bowel Syndrome (IBS), Functional Gastrointestinal Disorders (FGIDs), Gastrointestinal and Digestive Disorder, Abdominal Pain/ Discomfort, Pain, Functional Dyspepsia
Sex: All
Ages: 7 Years – 12 Years
Healthy volunteers: No
Phase: NA
Enrollment: 63
Sponsor: Baylor College of Medicine
Location: Baylor College of Medicine/Texas Children's Hospital Austin Texas
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, 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.
Eligibility Criteria
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)
Source: ClinicalTrials.gov (NCT07222943). StuddyBuddy aggregates publicly available trial information.