CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
Behavioral therapy +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05232097
NCT05232097N/ACompleted

Behavioral Therapy in Patients With Rumination

Helsinki University Central Hospital·interventional·Posted Feb 9, 2022·Updated Nov 18, 2024

In Brief

A clinical study evaluating Behavioral therapy and Physiotherapy for Functional Gastrointestinal Disorders. Completed, enrolled 11 participants across 2 sites.

Detailed Summary

The study aim is to diagnose patients with the rumination syndrome defined by the Rome IV criteria and to treat them with behavioral therapy consisting of diaphragmatic breathing exercises and physiotherapy to relax tensed abdominal and thoracic muscles. Before referral to the study, gastroscopy, esophageal hgh-resolution manometry and 24-hour esophageal pH and impedance monitoring are required to rule out other esophageal conditions. Twenty Finnish speaking, 15-70 years old patients will be enrolled in this open study. All patients will visit the gastroenterologist at onset of the study and at 6 months. All patients will be referred to the speech therapist for five one-hour sessions consisting of diaphragmatic belching exercises and to the physiotherapist for two one-hour sessions consisting of exercises to relax tensed thoracic and abdominal muscles. All patients will also visit once the psychologist and dietician. Symptoms will be evaluated by the Rome IV questionnaire for adult functional gastrointestinal diseases at onset and at the 6-month control. Health-related quality of life, depression, anxiety, functional capacity will be evaluated by specific questionnaires at onset of the study and at the 6-month control. Esophageal high-resolution manometry will be performed at the 6-month control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFinland
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedFeb 9, 2022
Enrollment StartJan 1, 2022
Primary CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 4.4 years ago

Interventions

Behavioral therapybehavioral

Diaphragmatic breathing exercises

Physiotherapybehavioral

Body awareness aiming at the patient becoming aware of the tensed thoracic and abdominal muscles and to reduce the tension by relaxation exercises taught by the psychophysical physiotherapist