Premenstrual SyndromeMLD-SMLDNCT07814807
The Effects of Manual Lymphatic Drainage and Self-Manual Lymphatic Drainage
A study testing Manual Lymphatic Drainage (MLD) and Self-Manual Lymphatic Drainage (Self-MLD) in people with Premenstrual Syndrome, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- Manual Lymphatic Drainage (MLD) and Self-Manual Lymphatic Drainage (Self-MLD)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2026to 5 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Cappadocia University Cappadocia Vocational College, Physiotherapy Program
Nevşehir
Merve KOKU, MSc. PT, +90 534 524 54 36, kokumrve@gmail.com
About this study
Official title: Comparison of the Effects of Manual Lymphatic Drainage and Self-Manual Lymphatic Drainage on the Autonomic Nervous System and Premenstrual Symptoms in Women With Premenstrual Syndrome: A Sham-Controlled Study
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.
Read the detailed description
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.
- Conditions
- Premenstrual Syndrome
- Being tested
- Manual Lymphatic Drainage (MLD), Self-Manual Lymphatic Drainage (Self-MLD), Sham Manual Lymphatic Drainage (Sham MLD)
- Keywords
- Premenstrual Syndrome, Manual Lymphatic Drainage, Self-Manual Lymphatic Drainage, Heart Rate Variability, Autonomic Nervous System, Edema, Pain
- Medical subject headings
- Premenstrual Syndrome, Edema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Lymphatic Drainage (MLD)Other
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.
Self-Manual Lymphatic Drainage (Self-MLD)Other
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.
Sham Manual Lymphatic Drainage (Sham MLD)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Manual Lymphatic Drainage | Experimental | 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. Receives: Other: Manual Lymphatic Drainage (MLD) |
| Self-Manual Lymphatic Drainage | Experimental | 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. Receives: Other: Self-Manual Lymphatic Drainage (Self-MLD) |
| Sham Manual Lymphatic Drainage | Sham comparator | 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. Receives: Other: Sham Manual Lymphatic Drainage (Sham MLD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Secondary outcomes (22)
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).
Measured: 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).
Measured: 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 (%).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start5 Oct 2026 (estimated)
- Primary completion5 May 2027 (estimated)
- Study completion5 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Taşpınar, Izmir Democracy University
- Investigators
- Betül TAŞPINAR, Prof. Dr., Principal investigator, Izmir Democracy UniversityMerve KOKU, MSc PT, Study director, Cappadocia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814807
- Sponsor's protocol ID
- Lymphatic Drainage-35
- Acronym
- MLD-SMLD
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Manual Lymphatic Drainage and Self-Manual Lymphatic Drainage on the Autonomic Nervous System and Premenstrual Symptoms in Women With Premenstrual Syndrome: A Sham-Controlled Study
- ClinicalTrials.gov ID
- NCT07814807
- Acronym / sponsor ID
- MLD-SMLD / Lymphatic Drainage-35
- Conditions
- Premenstrual Syndrome
- Keywords
- Premenstrual Syndrome, Manual Lymphatic Drainage, Self-Manual Lymphatic Drainage, Heart Rate Variability, Autonomic Nervous System, Edema, Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- 5 May 2027 (estimated)
- Study completion
- 5 Jul 2027 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual Lymphatic Drainage | Experimental | Other: Manual Lymphatic Drainage (MLD)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. |
| Self-Manual Lymphatic Drainage | Experimental | Other: Self-Manual Lymphatic Drainage (Self-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. |
| Sham Manual Lymphatic Drainage | Sham comparator | Other: Sham Manual Lymphatic Drainage (Sham 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Lymphatic Drainage (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. | Other | Manual Lymphatic Drainage |
| Self-Manual Lymphatic Drainage (Self-MLD)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. | Other | Self-Manual Lymphatic Drainage |
| Sham Manual Lymphatic Drainage (Sham MLD)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. | Other | Sham Manual Lymphatic Drainage |
Primary outcome
Premenstrual Syndrome Symptoms Assessed by the Premenstrual Syndrome Scale (PMSS)
Time frame: Baseline, after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
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
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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.
22 secondary outcomes
Heart Rate Variability - Standard Deviation of NN Intervals (SDNN)
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)
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Heart Rate Variability - pNN50
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Mean RR Interval
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
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
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Systolic Blood Pressure
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Diastolic Blood Pressure
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Heart Rate
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Pressure Pain Threshold
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
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
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
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
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
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
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
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
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
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)
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)
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
Time frame: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Betül TAŞPINAR, Prof. Dr. principal investigator
Izmir Democracy University
Merve KOKU, MSc PT study director
Cappadocia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Lymphatic Drainage (MLD) and Self-Manual Lymphatic Drainage (Self-MLD) in people with Premenstrual Syndrome, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Betül TAŞPINAR, Prof. Dr. (+90 506 680 44 26, ptbetul@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premenstrual Syndrome Symptoms Assessed by the Premenstrual Syndrome Scale (PMSS) (time frame: Baseline, after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.