Menstrual Complaints in Adolescents and Adults

Active, not recruiting

• Conditions: Dysmenorrhea; Menstrual Cramps; Heavy Menstrual Bleeding; Menstrual Cycle; Menstrual Distress (Dysmenorrhea); Mobile Health Technology (mHealth); Daily Activities; Menstrual Health Intervention; Menstrual Pain; Mobile Health

• Registration Number: NCT06921629
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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.

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 Timeline

• Study Start: 2023-05-11
• Study First Submitted: 2025-03-26
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-10
• Last Update Posted: 2025-04-10
• Primary Completion: 2026-05-11
• Study Completion: 2026-05-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of menstrual complaints	1 month	Prevalence of dysmenorrhea and heavy menstrual bleeding
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."

Secondary Outcome Measures

Name	Time	Method
Risk of clotting disorder (self-BAT questionnaire)	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.
Knowledge about menstruation and management, measured with the Menstrual Health Literacy survey.	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

Trial Locations

Locations (1)

Amsterdam UMC; 🇳🇱 Amsterdam, Noord-Holland, Netherlands