Menstrual Complaints in Adolescents and Adults
NCT06921629 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000
Last updated 2025-04-10
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.
Conditions
- Dysmenorrhea
- Heavy Menstrual Bleeding
- Daily Activities
- Menstrual Cramps
- Menstrual Cycle
- Menstrual Distress (Dysmenorrhea)
- Menstrual Health Intervention
- Menstrual Pain
- Mobile Health
- Mobile Health Technology (mHealth)
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.
Sponsors & Collaborators
-
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
lead OTHER
Principal Investigators
-
Robert de Leeuw, MD, PhD · Amsterdam UMC
Eligibility
- Min Age
- 12 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-11
- Primary Completion
- 2026-05-11
- Completion
- 2026-05-11
Countries
- Netherlands
Study Locations
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