Premenstrual Syndrome
Conditions
Keywords
Premenstrual Syndrome, Manual Lymphatic Drainage, Self-Manual Lymphatic Drainage, Heart Rate Variability, Autonomic Nervous System, Edema, Pain
Brief 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.
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.
Interventions
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.
OTHERSelf-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.
OTHERSham 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.
Sponsors
Izmir Democracy University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Premenstrual Syndrome Symptoms Assessed by the Premenstrual Syndrome Scale (PMSS) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate Variability - Standard Deviation of NN Intervals (SDNN) | Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks) | 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) | Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks) | 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 | Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks) | 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 | Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks) | 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. |
| Heart Rate Variability - Low-Frequency (LF) Power | Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks) | 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. |
| Heart Rate Variability - LF/HF Ratio | Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks) | 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. |
| Systolic Blood Pressure | Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks) | Systolic blood pressure (SBP) will be measured in the seated position using a digital blood pressure monitor and recorded in millimeters of mercury (mmHg). |
| Diastolic Blood Pressure | Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks) | Diastolic blood pressure (DBP) will be measured in the seated position using a digital blood pressure monitor and recorded in millimeters of mercury (mmHg). |
| Heart Rate | Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks) | 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). |
| Pressure Pain Threshold | 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 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. |
| Pressure Pain Tolerance | 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 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. |
| Pain Assessed by the McGill-Melzack Pain Questionnaire | Baseline, immediately after the third session (approximately 1 week), before the sixth session, and immediately after the sixth session (2 weeks) | 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. |
| Upper Extremity Volume as a Measure of Edema | Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks) | 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. |
| Lower Extremity Volume as a Measure of Edema | Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks) | 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. |
| Quality of Life Assessed by the Nottingham Health Profile | Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks) | 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. |
| Fatigue Severity Assessed by the Fatigue Severity Scale | Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks) | 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. |
| Depression Assessed by the Depression Anxiety Stress Scale-21 | Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks) | 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. |
| Anxiety Assessed by the Depression Anxiety Stress Scale-21 | Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks) | 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. |
| Stress Assessed by the Depression Anxiety Stress Scale-21 | Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks) | 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. |
| Heart Rate Variability - Low-Frequency Peak (LF Peak) | Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks) | 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. |
| Heart Rate Variability - High-Frequency Peak (HF Peak) | Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks) | 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. |
| Heart Rate Variability - Total Power | Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks) | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTBetül TAŞPINAR, Prof. Dr.
CONTACTMerve KOKU, MSc. PT.
PRINCIPAL_INVESTIGATORBetül TAŞPINAR, Prof. Dr.
Izmir Democracy University
STUDY_DIRECTORMerve KOKU, MSc PT
Cappadocia University
Outcome results
None listed