Open-Labelled Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children
Baylor College of Medicine
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.
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-treatme…
Eligibility
- Age range
- 7–12 years
- Sex
- All
- Healthy volunteers
- No
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 cogn…
Interventions
- BehavioralGuided Imagery Therapy
Participants will be asked to listen to a pre-recorded, 10 to 15 minute guided imagery therapy (GIT) sessions via mobile application 5 out of 7 days per week for 8 weeks in addition to their usual care for their abdominal pain.
Locations (2)
- Baylor College of Medicine/Texas Children's HospitalAustin, Texas
- Baylor College of Medicine / Texas Children's HospitalHouston, Texas