Using a mobile app for guided imagery therapy to treat children's abdominal pain
Pilot Efficacy of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children
This study is testing if a mobile app that helps kids use their imagination can reduce stomach pain in children aged 7 to 12 who have ongoing abdominal issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 7 Years to 12 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06653647 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a mobile application that delivers guided imagery therapy to children suffering from functional abdominal pain disorders. Participants aged 7 to 12 will be randomly assigned to either an immediate treatment group, which receives access to the therapy app right away, or a delayed treatment group, which will start the therapy after an 8-week waiting period. The intervention involves listening to pre-recorded guided imagery sessions for 10-15 minutes, five days a week, over eight weeks, alongside their usual care. Data will be collected through surveys and diaries to assess pain levels and quality of life before, during, and after the intervention.
Who should consider this trial
Good fit: Ideal candidates are children aged 7 to 12 years with diagnosed functional abdominal pain disorders who can communicate in English.
Not a fit: Patients with significant developmental delays, autism, or other serious co-morbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive, accessible method for managing chronic abdominal pain in children.
How similar studies have performed: Other studies have shown promise in using psychological therapies for abdominal pain, but this specific mobile app approach is relatively novel.
Eligibility criteria
Show full inclusion / 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)
Where this trial is running
Houston, Texas
- Baylor College of Medicine / Texas Children's Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: John M Hollier, MD, MS, MPH — Baylor College of Medicine
- Study coordinator: Laurel Cavallo
- Email: GITgoStudy@bcm.edu
- Phone: 713-581-0370
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.