Improving women's health with a digitally supported healthcare model for girls and young women with menstrual pain - nested randomized controlled trial

Improving women's health with a digitally supported healthcare model for girls and young women with menstrual pain - nested randomized controlled trial - MeMäF

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033614

Enrollment

220

Registered

2024-02-23

Start date

2024-06-08

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N94.4 N94.6

Interventions

Group 1: Intervention group: n= 165 girls and young women of the observational study (DRKS00033626) are offered specialized care in addition to using the project app "period.". This new care approach

Eligibility

Sex/Gender

Female

Age

16 Years to 24 Years

Inclusion criteria

Inclusion criteria: - at least two menstrual bleedings in the last three months; - most severe menstrual pain in the last three months is = 6 on the NRS (without pain medication); - most severe menstrual pain with pain medication in the last three months is = 4 on the NRS; - Currently no long-term hormonal treatment; - Informed consent; - own smartphone (iOS or Android) and consent to enter data via an app; - consent to participate in special care in accordance to §140a SGB V (contract with own statutory health insurance company: BARMER, DAK-Gesundheit, TK)

Exclusion criteria

Exclusion criteria: - Current pregnancy or pregnancy planned in the next 12 months; - irregular menstruation; - Existing gynecological diagnosis, which could be the cause of the menstrual pain

Design outcomes

Primary

Measure	Time frame
Number of days with menstrual pain in the past month after 6 months (week 21-24 of the RCT), measured with the app diary.	—

Secondary

Measure	Time frame
Characterization of the study population, pain intensity [VAS 0-10], number of associated symptoms, number of days with pain medication, pain medication consumption [tablets per day], pain-specific self-efficacy (FESS), quality of life (EQ-5D-5L), health state [NRS 0-100], performance [NRS 0-10], absenteeism [number of days], presenteeism [number of days] at baseline and every 3 months, health economic parameters/ICER, endometriosis risk, use of app functions, number of suspected side effects of the app and the multimodal treatment approach, number of serious adverse events	—

Measure

Time frame

Characterization of the study population, pain intensity [VAS 0-10], number of associated symptoms, number of days with pain medication, pain medication consumption [tablets per day], pain-specific self-efficacy (FESS), quality of life (EQ-5D-5L), health state [NRS 0-100], performance [NRS 0-10], absenteeism [number of days], presenteeism [number of days] at baseline and every 3 months, health economic parameters/ICER, endometriosis risk, use of app functions, number of suspected side effects of the app and the multimodal treatment approach, number of serious adverse events

—

Countries

Germany

Contacts

Public ContactDaniel Pach

Charité-Universitätsmedizin Berlin, Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie

daniel.pach@charite.de+49 30 450 529 068

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026