The Experience Sampling Method (ESM): Validation of a newly developed real-time Patient-Reported Outcome Measure (PROM) and its Evaluation of triggers for Chronic Abdominal Pai
Completed
- Conditions
- Irritable Bowel Syndrome10017977
- Registration Number
- NL-OMON42980
- Lead Sponsor
- Maastricht Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 73
Inclusion Criteria
Diagnosis of IBS according to Rome IV criteria, age 18-70, ability to understand and speak the concerning language, ability to understand how to use the ESM.
Exclusion Criteria
Any organic explanation for the abdominal complaints, a history of abdominal surgery (except for uncomplicated appendectomy, laparoscopic cholecystectomy and hysterectomy), start up of regularly used medication from one month before inclusion until the end of study participation.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study outcome comprehends the psychometric properties (i.e. content<br /><br>validity, cross-cultural adaptation, concurrent validity, internal consistency<br /><br>and test-retest reliability) of the PROM for symptom assessment of abdominal<br /><br>pain. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes are associations between the presence of psychosocial and<br /><br>environmental factors (e.g. as measured by the PROM) and an increase in ESM<br /><br>score for gastrointestinal symptoms from one time point (t-1) to the next (t).</p><br>