NCT07155291

Menstrual Pain Intervention Among Students

Evaluation of Easy-to-Implement Intervention for Menstrual Pain in a Series of N-of-1 Trials: Study Protocol of the Menstrual Pain Intervention Among Students Study (MPIS)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: University of Potsdam · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Dysmenorrhea, or menstrual pain, is a prevalent issue among female students, which negatively influences students' productivity, academic performance, and quality of life. This study explores a non-pharmaceutical physiotherapy method that has shown potential to decrease menstrual cramping, but research on its efficacy remains limited. The intervention is a visceral abdominal self-massage. Because individuals tend to respond differently to physiotherapy methods, the investigators aim to assess the effect of performing the self-massage regularly on the self-reported perception of menstrual pain and related symptoms of female students in Germany, with a series of N-of-1 trials. N-of-1 trials lasting up to 60 days are conducted with participants who regularly experience dysmenorrhea. Participants undergo a control (A) and an intervention phase (B), with a probable second control phase (A) depending on the individual cycle lengths and study start. Daily symptoms are recorded via the StudyU smartphone application. The baseline questionnaire collects demographic, lifestyle, and menstrual history information to identify potential effect modifiers. The intervention's effects will be estimated across individual and population levels. Participants will receive access to an analysis of their data. The results may benefit individual well-being and contribute to the exploration of a more holistic approach to menstrual health.

Conditions

• Dysmenorrhea
• Dysmenorrhea Primary
• Dysmenorrhea Secondary
• Dysmenorrhea Symptom

Interventions

Type	Name	Description
BEHAVIORAL	Abdominal Self-Massage	Daily self-administered visceral abdominal massage consisting of circular motions and pressure point techniques, performed for 5-20 minutes in total based on participant preference. The massage includes two parts: belly exercises (10 exercises) and pelvic exercises (3 exercises), with each exercise repeated 5-10 times or until the area feels relaxed. The app provides instructional videos and written step-by-step guides with drawings in English and German. Participants are recommended to use oil/cream, find a comfortable position, and integrate the massage into a daily routine.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-09-04
• Last updated: 2025-09-04