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NCT Number: NCT07457957

Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents

The aim of this study is to improve menstrual health-related quality of life in adolescents by using a mobile menstrual health tracker. We will perform a randomized controlled trial to evaluate the (cost)-effectiveness of this mHealth intervention.

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Key information

Conditions

Dysmenorrhea Adolescent Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Heavy Menstrual Bleeding Hemorrhage Menorrhagia Menstrual Bleeding, Heavy Menstrual Cramps Menstrual Cycle Abnormal Menstrual Discomfort Menstrual Disorder Menstrual Health Menstrual Health Intervention Menstruation Disturbances Mobile Application Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage mHealth

Age range

12 year–21 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Studies have shown that menstrual health-related quality of life is influenced mainly by pain, blood loss and school/work/leisure absenteeism. We hypothesize that using a mHealth intervention designed for adolescents will increase the self-awareness of an adolescent's menstrual health, including adequate healthcare-seeking. As a result, the intervention will increase menstrual health-related quality of life.

Postmenarchal adolescents aged between 12 and 22 years can be included in this study and will be randomised using 1:1 stratified randomisation in the intervention arm or control arm. Stratification factors are: age (<16 of ≥ 16 years old), use of hormonal anticonception (yes or no) and menstrual disturbance score (Period ImPact and Pain Assessment score <3 or ≥3).

Participants in the intervention arm will be asked to track their menstrual complaints in the mobile menstrual tracker and education application daily for at least three months. Participants in the control arm will not use the mobile menstrual tracker and education application for six months. Participants in the control arm also get access to the mobile menstrual tracker and education application six months after enrollment and after the primary outcome measurement at 6-months after enrollment.

The primary outcome measure is quality of life, using the PedsQL measured six months after enrollment. Secondary outcomes are school, work and leisure absenteeism, menstrual careseeking behavior, knowledge about menstrual complaints, the prevalence of suspected bleeding disorders, the prevalence of menstrual disturbance, the amount of menstrual blood loss, and societal costs.

All outcomes will be measured using online questionnaires send at 6, 12 and 24 months after enrollment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Dutch, English, Turkish or Moroccan-Arabic speaking
  • Post menarche
  • Access to a smartphone or tablet with iOS or Android operating system

Exclusion criteria

  • Amenorrhea
  • Pregnancy
  • No menstrual bleeding or withdrawel bleeding in the 3 months prior to inclusion.
  • Previously or currently under treatment by a health care provider for menstrual complaints

Treatment and study plan

Menstrual Tracker and Education Application

Other

The intervention is a mobile menstrual tracker and education application developed by Amsterdam UMC researchers. The app is developed to provide insight into the users' menstrual health and contains 11 trackable domains (menstrual bleeding, pain, impact, general health, mood, urine/stool, sleep, exercise, diet, sex, notes). It is connected to an online environment where the user gets educated about normal and abnormal menstrual health.

Primary outcomes

  1. Quality of Life Score

    Time frame: 6 months after enrollment

    Quality of life measured at baseline and 6 months after enrollment using the validated Pediatric Quality of Life 4.0 questionnaire.

Secondary outcomes

  1. Menstrual bleeding related quality of life

    Time frame: 6, 12, 24 months after enrollment

    The menstrual bleeding related quality of life assessed with the (adolescent) Menstrual Bleeding Questionnaire. The adolescent (<18) or adult version of the questionnaire will be used as appropriate.

  2. Knowledge about menstrual health

    Time frame: 6, 12 and 24 months after enrollment

    The knowledge about menstrual health will be assessed with the Menstrual Health Literacy survey.

  3. School-, work-, and leisure absences

    Time frame: 6, 12 and 24 months after enrollment

    The impact of menstrual complaints on school, work and leisure activities will be measured using the iMTA Productivity Cost Questionnaire (iPCQ). Impact of menstrual complaints is also reported in the mobile menstrual tracker and education app.

  4. Societal costs

    Time frame: 6, 12 and 24 months after enrollment

    Societal costs including healthcare use and prodictivity loss will be assessed using the iMTA Productivity Cost Questionnaire (iPCQ) and the iMTA Medical Consumption Questionnaire (iMCQ).

  5. Quality of Life for cost-effectiveness calculation

    Time frame: 6, 12 and 24 months after enrollment

    To calculate the cost-effectiveness of the intervention, the quality of life assessed with the 5-level EQ-5D (EQ-5D-5L) and EQ-5D-Y-5L as appropriate as a measure for effectiveness.

  6. Participants' experience of effectiveness

    Time frame: 6, 12 and 24 months after enrollment

    The effectiveness experienced by the participant is measured using the 1-item questionnaire Patient Global Impression of Change.

  7. Dose of mobile menstrual tracking and education application

    Time frame: 6, 12 and 24 months

    Logdata of the mobile menstrual tracking and education application will be used to calculate the dose of the intervention received.

  8. Menstrual disturbance

    Time frame: 6, 12 and 24 months after enrollment

    The menstrual disturbance score assessed with the Period ImPact and Pain Assessment tool (PIPPA)

Study contacts

Contact information is provided by the study sponsor or research team.

Esther Domenie, MSc

CONTACT

[email protected]

+31 6 23997219

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

The Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents - A Randomised Controlled Trial

Acronym: MGA

Important dates

Study start
2026
Primary completion
2027
Study completion
2029
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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