Status:
COMPLETED
Audio-recorded Gut-Hypnotherapy for Sleep and Pain in Pediatric Abdominal Pain Disorders
Lead Sponsor:
Children's Hospital at Montefiore
Conditions:
Irritable Bowel Syndrome
Disorders of Gut-brain Interaction
Eligibility:
All Genders
8-18 years
Phase:
NA
Brief Summary
Children with irritable bowel syndrome (IBS) and functional abdominal pain- not otherwise specified (FAP-NOS) have higher rates of poor sleep quality. This can be associated with worse abdominal pain ...
Detailed Description
Children with pain-predominant disorders of gut-brain interaction (DGBI) including irritable bowel syndrome (IBS) and functional abdominal pain-not otherwise specified (FAP-NOS) frequently experience ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT07216092
Start Date
March 1 2023
End Date
November 25 2024
Last Update
October 14 2025
Active Locations (1)
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1
Children's Hospital at Montefiore
Mahwah, New Jersey, United States, 07430