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The Effects of Manual Lymphatic Drainage and Self-Manual Lymphatic Drainage (MLD-SMLD)

7 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Betül TAŞPINAR, Prof. Dr.
  • Numero di telefono: +90 506 680 44 26
  • Email: ptbetul@gmail.com

Backup dei contatti dello studio

  • Nome: Merve KOKU, MSc. PT.
  • Numero di telefono: +90 534 524 54 36
  • Email: kokumrve@gmail.com

Luoghi di studio

  • Turchia (Türkiye)
      • Nevşehir, Turchia (Türkiye)
        • Cappadocia University Cappadocia Vocational College, Physiotherapy Program
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: 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.
Sperimentale: 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.
Altro: 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.
Comparatore fittizio: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Premenstrual Syndrome Symptoms Assessed by the Premenstrual Syndrome Scale (PMSS)
Lasso di tempo: 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.
Baseline, after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)
Heart Rate Variability - High-Frequency (HF) Power
Lasso di tempo: 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.
Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Heart Rate Variability - Standard Deviation of NN Intervals (SDNN)
Lasso di tempo: 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).
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)
Lasso di tempo: 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).
Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Heart Rate Variability - pNN50
Lasso di tempo: 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 (%).
Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Mean RR Interval
Lasso di tempo: 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.
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
Lasso di tempo: 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.
Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Heart Rate Variability - LF/HF Ratio
Lasso di tempo: 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.
Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Systolic Blood Pressure
Lasso di tempo: 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).
Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Diastolic Blood Pressure
Lasso di tempo: 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).
Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Heart Rate
Lasso di tempo: 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).
Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Pressure Pain Threshold
Lasso di tempo: 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.
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
Lasso di tempo: 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.
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
Lasso di tempo: 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.
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
Lasso di tempo: 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.
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
Lasso di tempo: 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.
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
Lasso di tempo: 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.
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
Lasso di tempo: 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.
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
Lasso di tempo: 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.
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
Lasso di tempo: 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.
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
Lasso di tempo: 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.
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)
Lasso di tempo: 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.
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)
Lasso di tempo: 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.
Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)
Heart Rate Variability - Total Power
Lasso di tempo: 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.
Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Adherence to Self-Manual Lymphatic Drainage
Lasso di tempo: Throughout the 2-week intervention period
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.
Throughout the 2-week intervention period
Satisfaction With the Assigned Lymphatic Drainage Intervention
Lasso di tempo: Immediately after completion of the 2-week intervention period
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.
Immediately after completion of the 2-week intervention period

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Izmir Democracy University

Investigatori

  • Investigatore principale: Betül TAŞPINAR, Prof. Dr., Izmir Democracy University
  • Direttore dello studio: Merve KOKU, MSc PT, Cappadocia University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

5 ottobre 2026

Completamento primario (Stimato)

5 maggio 2027

Completamento dello studio (Stimato)

5 luglio 2027

Date di iscrizione allo studio

Primo inviato

7 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 settembre 2026

Primo Inserito (Effettivo)

11 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Lymphatic Drainage-35

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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