Impact of an App on the Quality of Life and Symptoms in Individuals With Premenstrual Syndrome

Endo Health

Status

Completed

Conditions

Premenstrual Syndrome

Premenstrual Syndrome-PMS

Treatments

Device: PMS App

Study type

Interventional

Funder types

Industry

Identifiers

NCT06991413

RCT_PilotPMS

Details and patient eligibility

About

This pilot study explored the effectiveness and acceptance of a digital app for the self-management of PMS. A total of 175 participants were randomized into an intervention and a control group. Findings indicate that the app offers beneficial effects on PMS-specific symptoms and broader health aspects such as fatigue and emotional well-being. The study also provided valuable insights for the design of future larger trials and highlights the promising potential of the app to enhance individualized care.

Enrollment

175 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Legal capacity
Residency in Germany
Female gender
Age ≥18 years
Diagnosed and medically confirmed current PMS (N94.3)
Ownership of a smartphone and ability to use it
Internet access for app usage and questionnaire completion
Email address for registration
Willingness to complete questionnaires online
Motivation for regular app usage
Sufficient proficiency in the German language

Exclusion criteria

Pregnancy, breastfeeding, or the onset of menopause during the study period
Changes in hormonal therapy and/or use of antidepressants within eight weeks prior to the study start and/or planned in the upcoming 12 weeks
Previous or current access to the Endo-App or other comparable digital health applications, or current active prescription
Current participation in other clinical studies
Failure to meet the inclusion criteria