Menstrual Pain Intervention Among Students
- Conditions
- DysmenorrheaDysmenorrhea PrimaryDysmenorrhea SecondaryDysmenorrhea Symptom
- Registration Number
- NCT07155291
- Lead Sponsor
- University of Potsdam
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 46
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Daily Perceived Menstrual Pain 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 Outcome Measures
Name Time Method Pain Medication Intake 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.
Additional Menstrual Symptoms 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
* HeadachesMood Impact 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).
Symptom Narrative 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.