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Active, not recruiting Observational

Menstrual Complaints in Adolescents and Adults

NCT06921629 · tracked via the Priya Life Science Netherlands tracker
Phase
Observational
Started
2023-05-11
Last updated
2025-04-10

Condition(s) studied

DysmenorrheaHeavy Menstrual BleedingDaily ActivitiesMenstrual CrampsMenstrual CycleMenstrual Distress (Dysmenorrhea)Menstrual Health InterventionMenstrual PainMobile HealthMobile Health Technology (mHealth)

Investigational drug(s) / intervention(s)

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

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

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.

Study 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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
60 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Impact of menstrual complaints (registred in the MEK-app) — 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."
  • Prevalence of menstrual complaints — 1 month
    Prevalence of dysmenorrhea and heavy menstrual bleeding

Trial sites (1)

FacilityCityRegionStatus
Amsterdam UMC Amsterdam North Holland
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06921629 on ClinicalTrials.gov ↗ ← All trials in the Netherlands