An interventional study of Manual Lymphatic Drainage (MLD) and Self-Manual Lymphatic Drainage (Self-MLD) in Premenstrual Syndrome, sponsored by Izmir Democracy University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Izmir Democracy University · Not applicable, Interventional, and Treatment
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.
Premenstrual syndrome (PMS) is characterized by physical, emotional, and behavioral symptoms occurring during the luteal phase of the menstrual cycle. Manual lymphatic drainage (MLD) is a physiotherapy technique involving gentle, slow, rhythmic, and repetitive manual movements designed to support lymphatic flow. This study will investigate whether MLD and self-MLD influence autonomic nervous system activity and PMS-related symptoms and will compare their effects with a sham intervention.
Participants meeting the eligibility criteria will be randomly assigned to one of three groups: MLD administered by a physiotherapist, self-MLD performed by participants after instruction, or sham MLD. The intervention period will last 2 weeks during the luteal phase, with three sessions per week and six sessions in total.
Assessments will include the Premenstrual Syndrome Scale, blood pressure, heart rate and heart rate variability, pain threshold and tolerance, pain intensity, edema, quality of life, fatigue, depression, anxiety, and stress. Measurements will be performed at predetermined time points to evaluate both acute responses to the interventions and changes over the intervention period.
177 studies on the registry are indexed under Premenstrual Syndrome; 32 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 154 interventional studies indexed under Premenstrual Syndrome.
Browse Premenstrual Syndrome studies →Izmir Democracy University is the lead sponsor of 78 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a standard manual lymphatic drainage (MLD) protocol administered by an experienced physiotherapist. The intervention will include the basic regions and the upper and lower extremities using gentle, rhythmic maneuvers consistent with classical MLD techniques. The intervention will be administered during the luteal phase for 2 weeks, three sessions per week, for a total of six sessions. Each session will last approximately 45-60 minutes.
Other: Manual Lymphatic Drainage (MLD)
Participants will be taught simple and safe self-manual lymphatic drainage (self-MLD) techniques under the supervision of a physiotherapist. They will perform the techniques at home according to the predetermined protocol, with 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.
Other: Self-Manual Lymphatic Drainage (Self-MLD)
Participants will be positioned in the same manner as in the classical MLD intervention. 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 to provide tactile contact. The duration and schedule will be matched to the intervention protocol.
Other: Sham Manual Lymphatic Drainage (Sham MLD)
Manual 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.
Participants 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.
Participants 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.
Time frame: Baseline, after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
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.
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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).
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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).
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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 (%).
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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.
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Heart Rate Variability - Low-Frequency (LF) Power
Low-frequency (LF) power will be assessed as a frequency-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.
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Heart Rate Variability - LF/HF Ratio
The LF/HF ratio will be calculated as a frequency-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.
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Systolic Blood Pressure
Systolic blood pressure (SBP) will be measured in the seated position using a digital blood pressure monitor and recorded in millimeters of mercury (mmHg).
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Diastolic Blood Pressure
Diastolic blood pressure (DBP) will be measured in the seated position using a digital blood pressure monitor and recorded in millimeters of mercury (mmHg).
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Heart Rate
Heart rate will be assessed using a Polar H10 heart rate sensor while the participant is in a seated position and will be recorded in beats per minute (beats/min).
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Pressure Pain Threshold
Pressure pain threshold will be assessed using an algometer. The first pressure value at which the participant begins to perceive pain will be recorded. Measurements will be performed three times with 10-second rest intervals, and the mean value will be recorded in Newtons. Measurements will be performed at the vastus medialis, pectoralis major, gluteus maximus, gluteus medius, iliopsoas, lumbar paraspinal, and trapezius muscles.
Time frame: Baseline, immediately after the first session, immediately after the third session (approximately 1 week), before the sixth session, and immediately after the sixth session (2 weeks)
Pressure Pain Tolerance
Pressure pain tolerance will be assessed using an algometer. The pressure value at which the applied pressure becomes unbearable will be recorded. Pressure will be applied perpendicular to the measurement area at approximately 1 kg/cm²/s. Measurements will be performed at the vastus medialis, pectoralis major, gluteus maximus, gluteus medius, iliopsoas, lumbar paraspinal, and trapezius muscles.
Time frame: Baseline, immediately after the first session, immediately after the third session (approximately 1 week), before the sixth session, and immediately after the sixth session (2 weeks)
Pain Assessed by the McGill-Melzack Pain Questionnaire
Pain will be assessed using the McGill-Melzack Pain Questionnaire. The questionnaire evaluates pain location, sensory and perceptual characteristics, temporal characteristics, factors that increase or decrease pain, and pain intensity. Pain intensity is evaluated using five verbal categories ranging from mild to unbearable pain.
Time frame: Baseline, immediately after the third session (approximately 1 week), before the sixth session, and immediately after the sixth session (2 weeks)
Upper Extremity Volume as a Measure of Edema
Upper extremity edema will be assessed using circumference measurements and volumetric calculation. Circumference measurements will be obtained at 5-cm intervals using a non-elastic tape measure, from the styloid process to the axillary fossa. Limb volume will be calculated from the circumference measurements using the Frustum model.
Time frame: Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
Lower Extremity Volume as a Measure of Edema
Lower extremity edema will be assessed using circumference measurements and volumetric calculation. Circumference measurements will be obtained at 5-cm intervals using a non-elastic tape measure, from the lateral malleolus to the inguinal fold. Limb volume will be calculated from the circumference measurements using the Frustum model.
Time frame: Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
Quality of Life Assessed by the Nottingham Health Profile
Quality of life will be assessed using the Nottingham Health Profile (NHP). The first part contains 38 items across six domains: pain, emotional reactions, sleep, social isolation, physical activity, and energy level. Each domain has a maximum score of 100, with a total score ranging from 0 to 600. The second part ranges from 0 to 7. Higher scores indicate poorer quality of life.
Time frame: Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
Fatigue Severity Assessed by the Fatigue Severity Scale
Fatigue will be assessed using the Fatigue Severity Scale (FSS), which consists of 9 items scored from 1 (strongly disagree) to 7 (strongly agree). The total score is calculated as the arithmetic mean of the nine item scores. Higher scores indicate greater fatigue severity, and a score of 4 or higher indicates pathological fatigue.
Time frame: Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
Depression Assessed by the Depression Anxiety Stress Scale-21
Depression will be assessed using the depression subscale of the Depression Anxiety Stress Scale-21 (DASS-21). The depression subscale consists of 7 items, each scored from 0 to 3. Higher subscale scores indicate greater severity of depressive symptoms.
Time frame: Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
Anxiety Assessed by the Depression Anxiety Stress Scale-21
Anxiety will be assessed using the anxiety subscale of the Depression Anxiety Stress Scale-21 (DASS-21). The anxiety subscale consists of 7 items, each scored from 0 to 3. Higher subscale scores indicate greater severity of anxiety symptoms.
Time frame: Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
Stress Assessed by the Depression Anxiety Stress Scale-21
Stress will be assessed using the stress subscale of the Depression Anxiety Stress Scale-21 (DASS-21). The stress subscale consists of 7 items, each scored from 0 to 3. Higher subscale scores indicate greater severity of stress symptoms.
Time frame: Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
Heart Rate Variability - Low-Frequency Peak (LF Peak)
Low-frequency peak (LF peak) will be assessed as a frequency-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.
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Heart Rate Variability - High-Frequency Peak (HF Peak)
High-frequency peak (HF peak) will be assessed as a frequency-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.
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Heart Rate Variability - Total Power
Total power will be assessed as a frequency-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.
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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.
Time frame: Throughout the 2-week intervention period
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.
Time frame: Immediately after completion of the 2-week intervention period
Plan to share: No
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Izmir Democracy University