NCT07457957

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 874 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: Female
• Age: 12 Years – 21 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Dysmenorrhea
• Heavy Menstrual Bleeding
• Menstrual Cramps
• Menstrual Bleeding, Heavy
• Menstrual Discomfort
• Menstrual Cycle Abnormal
• Menstrual Disorder
• Menstrual Health
• Mobile Application
• mHealth
• Menstrual Health Intervention
• Adolescent

Interventions

Type	Name	Description
OTHER	Menstrual Tracker and Education Application	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.

Timeline

• Start date: 2026-02-16
• Primary completion: 2027-11-30
• Completion: 2029-05-31
• First posted: 2026-03-09
• Last updated: 2026-03-09

Locations

1 site across 1 country: Netherlands