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.
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
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
Parallel
Manual Lymphatic Drainage (MLD)
Other interventionManual lymphatic drainage will be administered by an experienced physiotherapist using classical MLD techniques. The intervention will include the basic regions and the upper and lower extremities using gentle, rhythmic maneuvers that support lymphatic circulation. Each session will last approximately 45-60 minutes. The intervention will be performed during the luteal phase of the menstrual cycle for 2 weeks, three sessions per week, for a total of six sessions.
Self-Manual Lymphatic Drainage (Self-MLD)
Other interventionParticipants will be taught simple and safe self-manual lymphatic drainage techniques under the supervision of a physiotherapist. They will perform the techniques at home according to the predetermined protocol. The frequency, duration, and application procedure will be explained in detail, and correct performance will be supported through online or face-to-face follow-up when necessary. The intervention will be performed during the luteal phase for 2 weeks, three sessions per week, for a total of six sessions.
Sham Manual Lymphatic Drainage (Sham MLD)
Other interventionParticipants will be positioned in the same manner as for classical MLD. Very light and irregular rhythmic touches that are not intended to increase lymphatic flow and are expected to have minimal therapeutic effect will be applied solely to provide tactile contact. The duration and schedule of the sham intervention will be matched to the study intervention protocol.
Premenstrual Syndrome Symptoms Assessed by the Premenstrual Syndrome Scale (PMSS)
Premenstrual symptoms will be assessed using the Premenstrual Syndrome Scale (PMSS). The PMSS consists of 44 items across nine subdimensions: depressive affect, anxiety, fatigue, irritability, depressive thoughts, pain, appetite changes, sleep changes, and bloating. Each item is scored from 1 to 5. The total score ranges from 44 to 220, with higher scores indicating greater severity of premenstrual symptoms.
Heart Rate Variability - High-Frequency (HF) Power
Heart rate variability (HRV) will be assessed using a Polar H10 heart rate sensor. RR intervals will be recorded for 5 minutes using the Elite HRV smartphone application. High-frequency (HF) power will be analyzed as a frequency-domain measure of HRV and autonomic nervous system activity.
Heart Rate Variability - Standard Deviation of NN Intervals (SDNN)
SDNN will be assessed as a time-domain parameter of heart rate variability. RR intervals will be recorded for 5 minutes using a Polar H10 heart rate sensor and the Elite HRV smartphone application. SDNN will be expressed in milliseconds (ms).
Heart Rate Variability - Root Mean Square of Successive Differences (RMSSD)
RMSSD will be assessed as a time-domain parameter of heart rate variability. RR intervals will be recorded for 5 minutes using a Polar H10 heart rate sensor and the Elite HRV smartphone application. RMSSD will be expressed in milliseconds (ms).
Heart Rate Variability - pNN50
pNN50 will be assessed as a time-domain parameter of heart rate variability based on 5-minute RR interval recordings obtained using a Polar H10 heart rate sensor and the Elite HRV smartphone application. pNN50 will be expressed as a percentage (%).
Mean RR Interval
Mean RR interval will be determined from 5-minute RR interval recordings obtained using a Polar H10 heart rate sensor and the Elite HRV smartphone application.
Adherence to Self-Manual Lymphatic Drainage
Adherence to self-manual lymphatic drainage will be assessed using a Self-MLD Diary. Participants will record the date, time, duration, body regions treated, and comments after each home session. Adherence will be calculated as the number of completed sessions divided by the number of planned sessions.
Satisfaction With the Assigned Lymphatic Drainage Intervention
Satisfaction with the assigned lymphatic drainage intervention will be assessed at the end of the study using a 5-item Likert-type satisfaction questionnaire. Participants will evaluate their satisfaction with the intervention to which they were assigned. Questionnaire results will be analyzed quantitatively.
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