Menstrual Complaints in Adolescents and Adults (MEK app)

April 3, 2025 updated by: Dr. Robert A. de Leeuw, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study was an online prospective cohort study and consisted of using the Menstruatie Educatie Kalender (Menstruation Education Calendar) application (MEK app) daily for at least one cycle with a questionnaire before and after the use of this application. Participants consisted of postmenarchal adolescents and adults with a menstrual cycle with monthly bleeding. The study involved minimal effort for participants: a baseline questionnaire at the start of the study, requiring approximately 10 minutes; daily app use for at least one cycle, taking around 20 seconds each day; and a final questionnaire at the end of the study, lasting about 10 minutes. Participants received no compensation for participating and the use of the MEK app was free.

Previous research on menstrual complaints in adolescents has considered sample sizes of approximately 1,000 participants to be representative of the population. Since this prospective cohort study about adolescent's menstrual complaints involved repeated measurements, and the literature suggested that repeated measurements of outcome variables increase study power and reduce the required sample size, this study aimed to include a total of 900 adolescents and 900 adults.

The study results were reported using descriptive statistical analyses. To compare dichotomous outcomes the chi-square test or the Fishers' exact test was used. Depending on the data distribution, the Student's t-test or Mann-Whitney U test was used to compare continuous outcomes. Mixed effects logistic regression was used for the association between menstrual complaints and the impact on daily life activities. The statistical analysis was performed in IBM SPSS Statistics version 28 using a two-sided p-values. P-values under 0.05 were considered statistically significant.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105AZ
        • Amsterdam UMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants were recruited from social media channels Facebook (@Uterine Repair Center), Instagram (@MenstruatieApp) and Tiktok (@MenstruatieEducatieApp), schools during biology class and from outpatient clinics, including pediatrics and adolescent medicine and gynecology, regardless of their reason for coming.

Description

The inclusion criteria were

  • post-menarcheal adolescents and adults aged 12-60 years,
  • having a menstrual cycle with monthly bleeding (also with an intra-uterine device or use of contraceptive pills),
  • speaking Dutch (MEK-app is available in Dutch only);
  • having a smartphone with the operating system Android or iOS and
  • obtaining informed consent from the participant and the parents of the participants aged 12-16 years.

The exclusion criteria were

  • amenorrhea
  • incompleted questionnaires
  • not using the MEK-app for at least one period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adolescents
postmenarchal adolescents between 12 and 18 years old, (according to the WHO's definition of adolescents) with monthly menstruation
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.
Adults
Postmenarchal adults between 19 and 60 years with monthly menstruation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of menstrual complaints (registred in the MEK-app)
Time Frame: 1 month
The impact of menstrual complaints (bleeding and pain) on daily activities in adolescents and adults registered in the MEK-app. Impact on daily life was assessed in the MEK app with the question: "Has your menstruation affected your daily activities?" Participants could respond with "yes" or "no."
1 month
Prevalence of menstrual complaints
Time Frame: 1 month
Prevalence of dysmenorrhea and heavy menstrual bleeding
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk of clotting disorder (self-BAT questionnaire)
Time Frame: 1 month
The risk of a clotting disorder, specifically in the groups with normal and heavy blood loss assessed with the self-BAT questionnaire. The results will be expressed as percentages of participants with increased self-BAT scores.
1 month
Knowledge about menstruation and management, measured with the Menstrual Health Literacy survey.
Time Frame: 1 month
The Menstrual Health Literacy Survey consisted of questions about among other things current management options for dysmenorrhea, impact of dysmenorrhea and/or pelvic pain on daily or social activities, impact of dysmenorrhea on academic performance or engagement, school and/or university support, health literacy around menstruation, sources of knowledge, what they consider normal regarding dysmenorrhea, which additional symptoms during menstruation they perceive as normal, and how they manage the pain. The questionnaire was as a mixture of closed, multiple-choice, and open-ended questions. The answers to the questions in this questionnaire will be shown in numbers and percentages
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Robert de Leeuw, MD, PhD, Amsterdam UMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2023

Primary Completion (Estimated)

May 11, 2026

Study Completion (Estimated)

May 11, 2026

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEK-app

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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