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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valeria Tisch | Contact | +49 176 75890213 | valeria.tisch@uni-potsdam.de | |
| Stefan Konigorski | Contact | +49 331 55094858 | stefan.konigorski@hpi.de |
| Name | Affiliation | Role |
|---|---|---|
| Stefan Konigorski, Dr. rer. nat. | Hasso-Plattner-Institut | Principal Investigator |
| Valeria Tisch, Master's Student | Hasso-Plattner-Institut | Principal Investigator |
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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).
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.
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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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.
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| 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):
| 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). | 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. | Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |