*The Experience Sampling Method (ESM): Validation of a newly developed real-time Patient-Reported Outcome Measure (PROM) and its Evaluation of triggers for Functional Dyspepsia*

Completed

• Conditions: Functional dyspepsia; unexplainable stomach complaints; 10017947

• Registration Number: NL-OMON48356
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

Inclusion criteria for patients with functional dyspepsia
* A diagnosis of functional dyspepsia according to Rome IV criteria (2):
- One or more of the following:
- Bothersome postprandial fullness
- Bothersome early satiation
- Bothersome epigastric pain
- Bothersome epigastric burning
AND
- No evidence of structural disease (including at upper endoscopy) that is
likely to explain the symptoms.
- Criteria fulfilled for the last 3 months with symptom onset at least 6
months before diagnosis.
* Age between 18 and 75 years;
* Ability to understand and speak the Dutch language;
* Ability to understand how to utilize the ESM tool.

Inclusion criteria for healthy volunteers
* Age between 18 and 75 years
* Ability to understand and speak the Dutch language
* Ability to understand how to utilize the ESM tool.

Exclusion Criteria

Exclusion criteria for patients with functional dyspepsia
* Any organic explanation for the gastrointestinal complaints;
* Initiation of regularly used medication from one month before inclusion until
the end of study participation;
* A history of upper digestive surgery influencing end points
* A history of radiation therapy of the abdomen
* Pregnancy
Exclusion criteria for healthy volunteers
* Current diagnosis of any gastrointestinal disorder
* Current gastrointestinal symptoms suiting the ROME IV criteria for FD
* Initiation of regularly used medication from one month before inclusion until
the end of study participation
* Pregnancy

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 of the PROM for<br /><br>symptom assessment in functional dyspepsia. </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>