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 Pain

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 Pain - ESM in IBS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42980

Enrollment

Registered

2016-11-02

Start date

2017-03-24

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The main study outcome comprehends the psychometric properties (i.e. content validity, cross-cultural adaptation, concurrent validity, internal consistency and test-retest reliability) of the PROM for symptom assessment of abdominal pain.	—

Secondary

Measure	Time frame
Secondary outcomes are associations between the presence of psychosocial and environmental factors (e.g. as measured by the PROM) and an increase in ESM score for gastrointestinal symptoms from one time point (t-1) to the next (t).	—

Countries

Netherlands

Outcome results