Menstrual Complaints in Adolescents and Adults (MEK app)

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

Status

Active, not recruiting

Conditions

Menstrual Cramps

Mobile Health

Menstrual Pain

Menstrual Health Intervention

Menstrual Distress (Dysmenorrhea)

Daily Activities

Mobile Health Technology (mHealth)

Dysmenorrhea

Menstrual Cycle

Heavy Menstrual Bleeding

Treatments

Other: Questionnaires

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

Study type

Observational

Funder types

Other

Identifiers

NCT06921629

MEK-app

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Ages

12 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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