Dysmenorrhea, Dysmenorrhea Primary, Dysmenorrhea Secondary, Dysmenorrhea Symptom
Conditions
Keywords
Abdominal Self-Massage, Massage Physiotherapy, Menstrual Health, N-of-1 Trial
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.
Interventions
BEHAVIORALAbdominal 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.
Sponsors
University of Potsdam
Study design
Allocation
NA
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 * Headaches |
| Mood 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. |
Contacts
Primary ContactValeria Tisch
Backup ContactStefan Konigorski
Outcome results
None listed