DysmenorrheaMPISNCT07155291
Menstrual Pain Intervention Among Students
A study testing Abdominal Self-Massage in people with Dysmenorrhea and Dysmenorrhea Primary, run by University of Potsdam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Dysmenorrhea, Dysmenorrhea Primary, Dysmenorrhea Secondary
- What is being tested?
- Abdominal Self-Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Substance abuse (e.g., alcohol, drugs)
- Planned surgery within the next four to five months
- Doctor's advice against proceeding with the intervention
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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)
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.
Read more
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.
- Being tested
- Abdominal Self-Massage
- Keywords
- Abdominal Self-Massage, Massage Physiotherapy, Menstrual Health, N-of-1 Trial
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal Self-MassageBehavioural
Also called Visceral 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Abdominal Self-Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days
Secondary outcomes (4)
Pain Medication Intake
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.
Measured: Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days
Additional Menstrual Symptoms
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
Measured: Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days
Mood Impact
Participants rate how symptoms affected mood on a scale from 0 (no impact at all) to 4 (very strongly negatively).
Measured: Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days
Symptom Narrative
Participants provide a daily free-text narrative describing their overall well-being, symptoms, and physical and emotional state.
Measured: Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Potsdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Konigorski, University of Potsdam
- Investigators
- Stefan Konigorski, Dr. rer. nat., Principal investigator, Hasso-Plattner-InstitutValeria Tisch, Master's Student, Principal investigator, Hasso-Plattner-Institut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155291
- Sponsor's protocol ID
- 8/2025
- Acronym
- MPIS
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan to make anonymized data publicly available, either fully or partially, in a recognized research data repository to support further scientific research. Data obtained through the StudyU application will be published in its designated publicly available repository (https://designer.studyu.health).
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07155291
- Acronym / sponsor ID
- MPIS / 8/2025
- Keywords
- Abdominal Self-Massage, Massage Physiotherapy, Menstrual Health, N-of-1 Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of PotsdamUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Abdominal Self-Massage | Experimental | Behavioral: Abdominal Self-MassageAll 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal Self-MassageAlso: Visceral Abdominal Self-MassageDaily 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. | Behavioural | Abdominal Self-Massage |
Primary outcome
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).
4 secondary outcomes
Pain Medication Intake
Time frame: Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days
Additional Menstrual Symptoms
Time frame: Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days
Mood Impact
Time frame: Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days
Symptom Narrative
Time frame: Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: Yes. The investigators plan to make anonymized data publicly available, either fully or partially, in a recognized research data repository to support further scientific research. Data obtained through the StudyU application will be published in its designated publicly available repository (https://designer.studyu.health).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefan Konigorski, Dr. rer. nat. principal investigator
Hasso-Plattner-Institut
Valeria Tisch, Master's Student principal investigator
Hasso-Plattner-Institut
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Self-Massage in people with Dysmenorrhea and Dysmenorrhea Primary, run by University of Potsdam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valeria Tisch (+49 176 75890213, valeria.tisch@uni-potsdam.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Perceived Menstrual Pain (time frame: Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.