Menstrual Pain Intervention Among Students

NCT ID: NCT07155291

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-01-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Abdominal Self-Massage

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.

Group Type: EXPERIMENTAL

Abdominal Self-Massage

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Visceral Abdominal Self-Massage

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Potsdam

OTHER

Sponsor Role: lead

Responsible Party

Stefan Konigorski

Dr. rer. nat.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan Konigorski, Dr. rer. nat.

Role: PRINCIPAL_INVESTIGATOR

Hasso-Plattner-Institut

Valeria Tisch, Master's Student

Role: PRINCIPAL_INVESTIGATOR

Hasso-Plattner-Institut

Central Contacts

Valeria Tisch

Role: CONTACT

valeria.tisch@uni-potsdam.de

+49 176 75890213

Stefan Konigorski

Role: CONTACT

stefan.konigorski@hpi.de

+49 331 55094858

Other Identifiers

8/2025

Identifier Type: -

Identifier Source: org_study_id