The Effects of Manual Lymphatic Drainage and Self-Manual Lymphatic Drainage (MLD-SMLD)
2026년 9월 7일 업데이트: Betül Taşpınar, Izmir Democracy University
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.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
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.
연구 유형
중재적
등록 (추정된)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Betül TAŞPINAR, Prof. Dr.
- 전화번호: +90 506 680 44 26
- 이메일: ptbetul@gmail.com
연구 연락처 백업
- 이름: Merve KOKU, MSc. PT.
- 전화번호: +90 534 524 54 36
- 이메일: kokumrve@gmail.com
연구 장소
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Nevşehir, 터키 (Türkiye)
- Cappadocia University Cappadocia Vocational College, Physiotherapy Program
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연락하다:
- Merve KOKU, MSc. PT
- 전화번호: +90 534 524 54 36
- 이메일: kokumrve@gmail.com
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-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Manual Lymphatic Drainage
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.
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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.
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실험적: Self-Manual Lymphatic Drainage
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.
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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.
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가짜 비교기: Sham Manual Lymphatic Drainage
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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Premenstrual Syndrome Symptoms Assessed by the Premenstrual Syndrome Scale (PMSS)
기간: Baseline, after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
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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.
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Baseline, after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
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Heart Rate Variability - High-Frequency (HF) Power
기간: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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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.
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Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Heart Rate Variability - Standard Deviation of NN Intervals (SDNN)
기간: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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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).
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Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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Heart Rate Variability - Root Mean Square of Successive Differences (RMSSD)
기간: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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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).
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Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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Heart Rate Variability - pNN50
기간: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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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 (%).
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Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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Mean RR Interval
기간: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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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.
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Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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Heart Rate Variability - Low-Frequency (LF) Power
기간: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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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.
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Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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Heart Rate Variability - LF/HF Ratio
기간: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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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.
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Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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Systolic Blood Pressure
기간: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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Systolic blood pressure (SBP) will be measured in the seated position using a digital blood pressure monitor and recorded in millimeters of mercury (mmHg).
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Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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Diastolic Blood Pressure
기간: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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Diastolic blood pressure (DBP) will be measured in the seated position using a digital blood pressure monitor and recorded in millimeters of mercury (mmHg).
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Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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Heart Rate
기간: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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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).
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Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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Pressure Pain Threshold
기간: 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)
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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.
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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)
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Pressure Pain Tolerance
기간: 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)
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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.
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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)
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Pain Assessed by the McGill-Melzack Pain Questionnaire
기간: Baseline, immediately after the third session (approximately 1 week), before the sixth session, and immediately after the sixth session (2 weeks)
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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.
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Baseline, immediately after the third session (approximately 1 week), before the sixth session, and immediately after the sixth session (2 weeks)
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Upper Extremity Volume as a Measure of Edema
기간: Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
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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.
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Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
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Lower Extremity Volume as a Measure of Edema
기간: Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
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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.
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Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
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Quality of Life Assessed by the Nottingham Health Profile
기간: Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
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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.
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Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
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Fatigue Severity Assessed by the Fatigue Severity Scale
기간: Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
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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.
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Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
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Depression Assessed by the Depression Anxiety Stress Scale-21
기간: Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
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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.
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Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
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Anxiety Assessed by the Depression Anxiety Stress Scale-21
기간: Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
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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.
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Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
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Stress Assessed by the Depression Anxiety Stress Scale-21
기간: Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
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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.
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Baseline, immediately after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
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Heart Rate Variability - Low-Frequency Peak (LF Peak)
기간: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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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.
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Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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Heart Rate Variability - High-Frequency Peak (HF Peak)
기간: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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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.
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Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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Heart Rate Variability - Total Power
기간: Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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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.
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Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adherence to Self-Manual Lymphatic Drainage
기간: Throughout the 2-week intervention period
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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.
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Throughout the 2-week intervention period
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Satisfaction With the Assigned Lymphatic Drainage Intervention
기간: Immediately after completion of the 2-week intervention period
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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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Immediately after completion of the 2-week intervention period
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Betül TAŞPINAR, Prof. Dr., Izmir Democracy University
- 연구 책임자: Merve KOKU, MSc PT, Cappadocia University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 5일
기본 완료 (추정된)
2027년 5월 5일
연구 완료 (추정된)
2027년 7월 5일
연구 등록 날짜
최초 제출
2026년 9월 7일
QC 기준을 충족하는 최초 제출
2026년 9월 7일
처음 게시됨 (실제)
2026년 9월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 7일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Lymphatic Drainage-35
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .