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NCT Number: NCT07155291

Menstrual Pain Intervention Among Students

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Visceral Abdominal Self-Massage

Primary outcomes

  1. Daily Perceived Menstrual Pain

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

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

Secondary outcomes

  1. Pain Medication Intake

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

    Participants select which pain medication was used (if any) from a predefined list including: acetylsalicylic acid (Aspirin), butylscopolamine (Buscopan), butylscopolamine + paracetamol combinations, diclofenac (Voltaren), ibuprofen (Nurofen, Dolormin Extra), metamizole (Novalgin), naproxen (Dolormin for Women), paracetamol (Benuron), or other medications. Participants also report the number of tablets taken.

  2. Additional Menstrual Symptoms

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

    Participants indicate if any of the following additional symptoms are experienced (Yes/No for each):

    • Cramps
    • Lower back pain
    • Nausea, vomiting, or diarrhea
    • Painful urination
    • Dyschezia
    • Abdominal bloating
    • Painful intercourse
    • Fatigue or difficulty concentrating
    • Fainting
    • Headaches
  3. Mood Impact

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

    Participants rate how symptoms affected mood on a scale from 0 (no impact at all) to 4 (very strongly negatively).

  4. Symptom Narrative

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

    Participants provide a daily free-text narrative describing their overall well-being, symptoms, and physical and emotional state.

Study contacts

Contact information is provided by the study sponsor or research team.

Stefan Konigorski

CONTACT

[email protected]

+49 331 55094858

Valeria Tisch

CONTACT

[email protected]

+49 176 75890213

Sponsors and collaborators

Lead sponsor

University of Potsdam

Other

Registry information

Official study title

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)

Acronym: MPIS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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