Experience Sampling Method for Symptom Assessment in Irritable Bowel Syndrome
CompletedNCT02880722
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Reliable patient reported outcome measures (PROM's) for symptom assessment in irritable bowel syndrome are essential in order to investigate natural disease course and potential treatment options aimed at symptom improvement, since biological markers are currently unavailable. Currently used symptom assessment methods, i.e. end-of-day or end-of-week questionnaires, have considerable limitations. The Experience Sampling Method (ESM), an electronic questioning method characterized by random and repeated, momentary assessments in the subject's current state and environment, might overcome these limitations. Aim of this study is to validate an IBS-specific electronic patient-reported outcome measure, based on the Experience Sampling Method-principle, for symptom assessment in IBS.
Study details
- Official title
- Development and Validation of a Real-time Patient-Reported Outcome Measure for Chronic Abdominal Pain: The Experience Sampling Method (ESM)
- Conditions
- Sponsor
- Maastricht University Medical Center
- Collaborators
- Grünenthal GmbH
- Start date
- 2016-10
- Primary completion
- 2022-05
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Netherlands
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Diagnosis of irritable bowel syndrome according to Rome IV criteria. * Ability to understand and speak the national language of the concerning center. * Ability to understand how to utilize the ESM-tool. 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02880722