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NCT07814807
The Effects of Manual Lymphatic Drainage and Self-Manual Lymphatic Drainage
Conditions: Premenstrual Syndrome
Sex: Female
Ages: 18 Years – 40 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Izmir Democracy University
Location: Cappadocia University Cappadocia Vocational College, Physiotherapy Program Nevşehir
Summary
This randomized controlled study aims to compare the effects of manual lymphatic drainage (MLD), self-manual lymphatic drainage (self-MLD), and sham MLD on autonomic nervous system activity and premenstrual symptoms in women with premenstrual syndrome (PMS). A total of 60 women with PMS will be randomly assigned to three groups: MLD, self-MLD, or sham MLD. The intervention will be conducted during the luteal phase of the menstrual cycle for 2 weeks, with three sessions per week, for a total of six sessions. Outcomes will include premenstrual symptoms, heart rate and heart rate variability, blood pressure, pain, edema, quality of life, fatigue, depression, anxiety, and stress. Assessments will be performed at predetermined time points before, during, and after the intervention to compare the acute and overall effects of the three approaches.
Eligibility Criteria
Inclusion Criteria:
* Female participants aged 18-40 years
* Having a regular menstrual cycle every 24-32 days during the last 6 months
* Having symptom severity above the cut-off score determined according to the Premenstrual Syndrome Scale (PMSS) during the premenstrual period
* Having premenstrual syndrome symptoms for at least the last 3 menstrual cycles
* Being literate and having the cognitive ability to complete the questionnaires
* Providing voluntary informed consent after being informed about the study
Exclusion Criteria:
* Having an irregular menstrual cycle, amenorrhea, or being in the menopausal period
* Being pregnant or breastfeeding
* Having a history of significant cardiovascular, respiratory, neurological, orthopedic, or metabolic disease
* Regular use of medications that may affect the autonomic nervous system, pain, or sleep, such as antidepressants or beta-blockers
* Having a condition that constitutes a contraindication to manual lymphatic drainage, such as acute infection, deep vein thrombosis, or advanced heart failure
Source: ClinicalTrials.gov (NCT07814807). StuddyBuddy aggregates publicly available trial information.