N94.4
Conditions
Interventions
Group 1: Pilates training twice weekly
Group 2: Placebo capsules twice daily
Group 3: No treatment
Sponsors
Hochschule für angewandte Wissenschaften Coburg
Eligibility
Sex/Gender
Female
Age
18 Years to 30 Years
Inclusion criteria
Inclusion criteria: Self-reported regular menstrual cycle (approximately 26-34 days), dysmenorrhea during the last 3 periods = 6 on an 11-level NRS, primary dysmenorrhea and/or no known medical cause for the dysmenorrhea, sufficient knowledge of German to answer the questionnaires, written informed consent for study participation and data collection, no practice of Pilates training within the last year, refraining from new physical activities and of taking placebos for the duration of the study, apart from the study interventions.
Exclusion criteria
Exclusion criteria: Use of psychotropic drugs and/or manifest mental illness (e.g., recurrent depression, generalized anxiety disorder, addictive disorder), use of hormonal contraceptives (during the last three periods), pregnancy or lactation, intensive physical training.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group differences (both Pilates and open-label placebos vs. no treatment) of the pre-post change in menstrual pain (composite score of minimum, maximum, and average pain assessed on 11-point numeric rating scales, NRS) on the first 3 days of menstrual cycle. | — |
Secondary
| Measure | Time frame |
|---|---|
| Group differences of pre-post changes in salivary prostaglandin concentration (PGE2, PGF2alpha), depression, anxiety, and stress levels (DASS), physical and psychological quality of life (SF-12). In addition, the role of treatment expectations (TEX-Q, 11-point NRS) as well as differences in outcomes between the Pilates and the open-label placebo groups will be explored. | — |
Countries
Germany
Contacts
Public ContactSandra Ort
Hochschule für angewandte Wissenschaften Coburg
Outcome results
None listed