An interventional study of Menstrual Tracker and Education Application in Dysmenorrhea, Heavy Menstrual Bleeding and Menstrual Cramps, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Not yet recruiting at 1 site in Netherlands. Open to female participants aged 12 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Other
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.
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.
430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.
This study's planned enrollment of 874 is above the median of 62 across 363 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Participants in the 'App group' arm will be asked to record their menstrual health complaints daily in the mobile menstrual tracker and education application.
Other: Menstrual Tracker and Education Application
Participants in the 'waitlist group' will not directly get access to the mobile menstrual tracker and education application. They will be put on a 'waitlist'. Six months after inclusion and after completing the 6-month questionnaire, participants will get access to the application and are free to install and use it if desired.
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.
Quality of Life Score
Quality of life measured at baseline and 6 months after enrollment using the validated Pediatric Quality of Life 4.0 questionnaire.
Time frame: 6 months after enrollment
Menstrual bleeding related quality of life
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.
Time frame: 6, 12, 24 months after enrollment
Knowledge about menstrual health
The knowledge about menstrual health will be assessed with the Menstrual Health Literacy survey.
Time frame: 6, 12 and 24 months after enrollment
School-, work-, and leisure absences
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.
Time frame: 6, 12 and 24 months after enrollment
Societal costs
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).
Time frame: 6, 12 and 24 months after enrollment
Quality of Life for cost-effectiveness calculation
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.
Time frame: 6, 12 and 24 months after enrollment
Participants' experience of effectiveness
The effectiveness experienced by the participant is measured using the 1-item questionnaire Patient Global Impression of Change.
Time frame: 6, 12 and 24 months after enrollment
Dose of mobile menstrual tracking and education application
Logdata of the mobile menstrual tracking and education application will be used to calculate the dose of the intervention received.
Time frame: 6, 12 and 24 months
Menstrual disturbance
The menstrual disturbance score assessed with the Period ImPact and Pain Assessment tool (PIPPA)
Time frame: 6, 12 and 24 months after enrollment
Start is estimated for Feb 2026; primary completion for Nov 2027, 21 months later.
Of 178 non-industry interventional studies with no phase under Dysmenorrhea, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's planned 21 months is above that.
Counting every sponsor, half of 188 studies reached it within 8 months; a quarter within 3 and three quarters within 16.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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