Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2025-12-24 @ 3:24 PM
NCT ID:
NCT07216092
Eligibility Criteria:
Inclusion Criteria:
* English speaking
* ages 8 to 18 years
* met Rome IV criteria for FAP-NOS or IBS
* abdominal pain severity \>3/10 in the past 2 weeks
* minimum of 1 day of pain in the past 2 weeks
* mild SRI and/or SD as determined by the PROMIS 4- question short-form questionnaires
* stable medication regimen or dietary therapy for \>2 weeks prior to enrollment
Exclusion Criteria:
* disability that could hinder their understanding of the audio material
* previous experience with guided imagery for treatment of abdominal pain
* psychiatric disorder with psychotic elements such as dissociative symptoms
* other chronic gastrointestinal disease including inflammatory bowel disease, celiac disease, or eosinophilic esophagitis
* other chronic inflammatory conditions
* previous gastrointestinal surgery
* a diagnosis of a sleep disorder such as narcolepsy or sleep apnea.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
18 Years
Study:
NCT07216092
Study Brief:
Protocol Section:
NCT07216092