Menstrual Complaints in Adolescents and Adults

NCT06921629 | Active Not Recruiting

• 1 other identifier: MEK-app
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Impact of menstrual complaints (registred in the MEK-app)

  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."

  1 month

• Prevalence of menstrual complaints

  Prevalence of dysmenorrhea and heavy menstrual bleeding

  1 month

Secondary Outcomes (2)

• Risk of clotting disorder (self-BAT questionnaire)

  1 month

• Knowledge about menstruation and management, measured with the Menstrual Health Literacy survey.

  1 month

Study Arms (2)

Adolescents

postmenarchal adolescents between 12 and 18 years old, (according to the WHO's definition of adolescents) with monthly menstruation

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

Adults

Postmenarchal adults between 19 and 60 years with monthly menstruation

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

Interventions

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

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

Adolescents; Adults

Questionnaires OTHER

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.

Adolescents; Adults

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• amenorrhea
• incompleted questionnaires
• not using the MEK-app for at least one period

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 38437753 BACKGROUND

MeSH Terms

Conditions

Dysmenorrhea; Menorrhagia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Robert de Leeuw, MD, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD. Principal Investigator

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 10, 2025
• Study Start: May 11, 2023
• Primary Completion: May 11, 2026
• Study Completion: May 11, 2026
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

NL (1)