Menstrual Pain Intervention Among Students (MPIS)

University of Potsdam

Status: Not yet enrolling

Conditions: Dysmenorrhea Secondary; Dysmenorrhea; Dysmenorrhea Symptom; Dysmenorrhea Primary

Treatments: Behavioral: Abdominal Self-Massage

Study type: Interventional

Funder types: Other

Identifiers

NCT07155291

8/2025

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female students living in Germany
• Have consistently experienced menstrual pain and other symptoms primarily during menstruation for at least the last three cycles
• Regular access to a smartphone on which the StudyU (https://www.studyu.health/) application can be installed
• Informed consent
• Proficiency in English or German

Exclusion criteria

• Age under 18 or over 45 years
• Participation in a different intervention study during the duration of this study
• Use of hormonal treatments affecting the menstrual cycle
• Confirmed or suspected pregnancy
• Presence of contraindicated disorders or diseases for massage
• Severe psychiatric conditions impairing informed consent or reliable participation
• Substance abuse (e.g., alcohol, drugs)
• Planned surgery within the next four to five months
• Doctor's advice against proceeding with the intervention

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Crossover Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Abdominal Self-Massage

Experimental group

Description:

All participants follow an ABA intervention sequence of 60 days, where A represents the control phase and B the intervention phase. The phase timing is adjusted to individual menstrual cycle lengths. During the intervention phase, participants are instructed to perform a self-administered abdominal massage. During the control phases, participants maintain usual care with no intervention. Daily symptoms are recorded throughout all phases.

Treatment:

Behavioral: Abdominal Self-Massage