Clinical trial NCT06921629: Menstrual Complaints in Adolescents and Adults
Official title: The Prevalence and Impact of Menstrual Complaints in Adolescents and Adults - a Prospective Cohort
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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)
Keywords: Dysmenorrhea
Heavy Menstrual Bleeding
Menstrual complaints
Impact of menstrual complaints
daily activities
Adolescents
Adults
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 2000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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 outcomes:
measure: Impact of menstrual complaints (registred in the MEK-app)
timeFrame: 1 month
measure: Prevalence of menstrual complaints
timeFrame: 1 month
Secondary outcomes:
measure: Risk of clotting disorder (self-BAT questionnaire)
timeFrame: 1 month
measure: Knowledge about menstruation and management, measured with the Menstrual Health Literacy survey.
timeFrame: 1 month
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC
name: Robert de Leeuw, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ozcan H, Burger NB, Derksen ME, Peute LW, Huirne JAF, De Leeuw RA. The differences between adults and adolescents using a mobile health application for menstrual complaints: A usability and qualitative study. Int J Med Inform. 2024 May;185:105382. doi: 10.1016/j.ijmedinf.2024.105382. Epub 2024 Feb 23.