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NCT06921629

Menstrual Complaints in Adolescents and Adults

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

View on ClinicalTrials.gov

Summary

The aim of this study is to investigate the prevalence of menstrual complaints and their impact on daily life activities (school/work absence, absence from social activities, sports) in adults and adolescents.

Official title: The Prevalence and Impact of Menstrual Complaints in Adolescents and Adults - a Prospective Cohort

Key Details

Gender

All

Age Range

12 Years - 60 Years

Study Type

OBSERVATIONAL

Enrollment

2000

Start Date

2023-05-11

Completion Date

2026-05-11

Last Updated

2025-04-10

Healthy Volunteers

No

Interventions

OTHER

Menstruatie Educatie Kalender (Menstrution Education Calendar) application (MEK-app)

The MEK-APP is a mHealth application to evaluate menstrual complaints like heavy menstrual blood loss and dysmenorrhea. The MEK-APP is a calendar and facilitates daily monitoring of pain intensity using a Visual Analogue Scale (VAS), the amount of blood loss through a pictorial blood loss assessment chart (PBAC), and the impact of these complaints on daily life. The MEK-APP followed the waterfall methodology for software development and the usability was evaluated by both adults and adolescents(4). Furthermore, the MEK app has been approved by the privacy and security officers of Amsterdam UMC

OTHER

Questionnaires

After registration for this study via www.mijnmenstruatie.nl (which has also been approved by the privacy and security officers of Amsterdam UMC), participants received the first digital questionnaire. This questionnaire consisted of a baseline questionnaire, the electronic self bleeding assessment tool (e-self-BATH) and the Menstrual Health Literacy questionnaire. After using the MEK-app for at least one month, participants received an e-mail with the second questionnaire. This questionnaire consisted of the Menstrual Bleeding Questionnaire; Period ImPact and Pain Assesment; Pelvic Pain Impact Questionnaire; ENDOPAIN-4D; Endometriosis Health Profile 5 and iMTA Productivity Cost Questionnaire.

Locations (1)

Amsterdam UMC

Amsterdam, North Holland, Netherlands