Menstrual Pain Intervention Among Students

NCT07155291 | Not Yet Recruiting

• 1 other identifier: 8/2025
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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

Keywords

Abdominal Self-Massage; Massage Physiotherapy; Menstrual Health; N-of-1 Trial

Outcome Measures

Primary Outcomes (1)

• Daily Perceived Menstrual Pain

  Participants assess the severity of menstrual pain on a visual analog scale from 0 to 10 (0=no pain, 10=worst pain imaginable).

  Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days

Secondary Outcomes (4)

• Pain Medication Intake

  Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days

• Additional Menstrual Symptoms

  Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days

• Mood Impact

  Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days

• Symptom Narrative

  Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days

Study Arms (1)

Abdominal Self-Massage

EXPERIMENTAL

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.

Behavioral: Abdominal Self-Massage

Interventions

Abdominal Self-Massage 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.

Also known as: Visceral Abdominal Self-Massage

Abdominal Self-Massage

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Potsdam: lead

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Stefan Konigorski, Dr. rer. nat.

  Hasso-Plattner-Institut

  PRINCIPAL INVESTIGATOR

• Valeria Tisch, Master's Student

  Hasso-Plattner-Institut

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valeria Tisch

CONTACT

+49 176 75890213; valeria.tisch@uni-potsdam.de

Stefan Konigorski

CONTACT

+49 331 55094858; stefan.konigorski@hpi.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. rer. nat.

Model Details: Series of N-of-1 trials: The study follows an A-B-A design where A represents control/baseline periods and B represents the intervention period, with timing adjusted to individual menstrual cycle lengths.

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 4, 2025
• Study Start: September 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The study protocol and the Statistical Analysis Plan will be made available before starting data analysis (approximately until end of November) and remain available throughout the duration of the study registration.