Using a mobile app for guided imagery therapy to treat children's abdominal pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.