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Manual Lymphatic Drainage Versus Classical Massage on Heart Responses and Mood in Hemodialysis

2026. november 6. frissítette: Melike Davarcı, Mersin University

Acute Effects of Manual Lymphatic Drainage and Classical Massage on Cardiovascular and Autonomic Responses and Mood in Patients Undergoing Hemodialysis: A Randomized Controlled Crossover Experimental Study

The goal of this randomized controlled crossover trial is to learn whether manual lymphatic drainage (MLD) and classical massage have different short-term effects on the heart, the nervous system, and mood in adults aged 18 to 65 receiving hemodialysis. A total of 60 patients from two hemodialysis centers in Tarsus, Mersin, Türkiye, are planned to take part.

The main questions it aims to answer are:

  • Do MLD and classical massage differ in their short-term effects on autonomic nervous system responses, measured by heart rate variability (SDNN, RMSSD, LF, HF, LF/HF)? (Primary hypothesis 1)
  • Do MLD and classical massage differ in their short-term effects on cardiovascular responses, measured by systolic and diastolic blood pressure and heart rate? (Primary hypothesis 2)
  • Do MLD and classical massage differ in their short-term effects on mood (fatigue, vigor, tension, and confusion), measured by the Profile of Mood States - Short Form? (Secondary hypothesis)

Researchers will compare MLD with classical massage (active comparator). Each participant will receive both massages in a randomly assigned order (MLD first or classical massage first), so each participant serves as their own control. In addition, a no-massage control measurement will be taken in the week before the massages to show the changes caused by the hemodialysis session alone.

Participants will:

  • In the first week (control period), have their blood pressure, heart rate, and heart rate variability measured three times during a hemodialysis session without any massage.
  • In the second week, receive a 20-minute MLD or classical massage on both legs (thigh, lower leg, and foot), starting one hour after the beginning of the hemodialysis session.
  • After a one-week break (washout period), receive the other type of massage in the same way.
  • Have their blood pressure, heart rate, and heart rate variability measured before each massage, right after it, and 30 minutes later. Heart rate variability will be recorded for 5 minutes with a chest strap.
  • Complete a short mood questionnaire.

A tanulmány áttekintése

Részletes leírás

Cardiovascular disease is the leading cause of death in patients receiving hemodialysis (HD), accounting for about half of all deaths in this group. Blood pressure variability during dialysis is closely linked to cardiovascular events, and autonomic imbalance contributes to complications such as intradialytic hypotension and hypertension, each affecting about 15% of patients. Heart rate variability (HRV) is a non-invasive indicator of cardiac autonomic regulation and is reduced in chronic kidney disease. In addition, anxiety and depressive symptoms are common in HD patients and are associated with lower quality of life. Therefore, cardiovascular, autonomic, and emotional responses should be considered together during HD.

Massage is a low-cost, easy-to-apply, non-invasive nursing intervention with a low risk of serious side effects. Mechanical stimulation of the skin, muscle, and fascia may influence autonomic nervous system activity. Manual lymphatic drainage (MLD) is a technique that uses light, slow, rhythmic pressure to support lymphatic flow and has been associated with parasympathetic activation and relaxation. However, evidence on the cardiovascular and autonomic effects of MLD is limited, and its acute effects when applied during HD have not been studied.

Aim

The aim of this study is to evaluate and compare the acute cardiovascular, autonomic, and mood effects of 20-minute MLD and 20-minute classical massage applied during hemodialysis. The study is expected to help identify manual techniques that support cardiovascular and autonomic balance and to contribute to the development of evidence-based, non-pharmacological nursing interventions for HD care.

Originality

Previous massage studies in HD patients have mainly focused on symptoms and quality of life, such as fatigue, restless legs syndrome, muscle cramps, and sleep quality. Studies on the autonomic effects of MLD have mostly been conducted in healthy or stressed individuals. To the investigators' knowledge, no study has directly compared MLD and classical massage in terms of acute cardiovascular and autonomic responses in HD patients. This study is original in that:

  • It evaluates HRV together with blood pressure and heart rate, allowing a multidimensional assessment of the acute physiological responses to two manual techniques during HD.
  • It assesses acute changes in mood within a single dialysis session, whereas previous studies have focused on long-term psychological outcomes.
  • It uses a crossover design in which each participant receives both interventions and serves as their own control, which reduces between-subject variability and increases statistical power.
  • The interventions are applied during the dialysis session and can be integrated into routine care without adding extra time burden for patients.

Hypotheses

In hemodialysis patients, the effects of 20-minute MLD and 20-minute classical massage:

  • Primary Hypothesis 1 (H1): differ in terms of acute autonomic responses (HRV).
  • Primary Hypothesis 2 (H2): differ in terms of acute cardiovascular responses (systolic and diastolic blood pressure, heart rate).
  • Secondary Hypothesis (H3): differ in terms of acute mood.

Methods

Design: Two-period, two-sequence (AB/BA), randomized controlled crossover study.

Participants: Patients aged 18 to 65 years who have received HD for at least three months, three times a week, about four hours per session. Main exclusion criteria are conditions preventing massage (e.g., foot ulcer, amputation, orthopedic problems), cancer, chronic respiratory failure, heart failure, rheumatoid arthritis, lupus, diagnosed psychiatric illness, use of sleeping pills or sedatives, atrial fibrillation, and pacemaker use.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

60

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

Inclusion Criteria:

  • Being between 18 and 65 years of age
  • Having received hemodialysis treatment for at least three months
  • Receiving hemodialysis treatment at least three times a week, each session lasting approximately four hours
  • Volunteering to participate in the study and providing written informed consent

Exclusion Criteria:

  • Having a medical condition that would prevent the intervention, such as a foot ulcer, amputation, or an orthopedic problem
  • Having a chronic disease such as cancer, chronic respiratory failure, heart failure, rheumatoid arthritis, or lupus erythematosus
  • Having been diagnosed with a psychiatric illness such as depression or bipolar disorder
  • Having a history of a pathological condition, injury, or surgical procedure that would prevent the intervention from being performed safely
  • Using sleeping pills or sedatives, as these may affect autonomic responses and HRV measurements
  • Having a history of atrial fibrillation or having a pacemaker

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Támogató gondoskodás
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Crossover kiosztás
  • Maszkolás: Egyetlen

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: MLD then Classical Massage (AB)

Participants will undergo a no-intervention control measurement (Z0), then receive 20 minutes of manual lymphatic drainage on both lower extremities during hemodialysis in Period 1, and after a one-week washout period, 20 minutes of classical massage in Period 2.

20-minute MLD applied to both lower extremities (thigh, lower leg, and foot) one hour after the start of the hemodialysis session, using light, slow, rhythmic, superficial stroking, pumping, circular, and rotary maneuvers directed toward the inguinal, popliteal, and medial malleolar lymphatic regions.

20-minute classical massage applied to both lower extremities (thigh, lower leg, and foot) one hour after the start of the hemodialysis session, using effleurage, petrissage, and friction, beginning and ending with effleurage.

Kísérleti: Classical Massage then MLD (BA)

Participants will undergo a no-intervention control measurement (Z0), then receive 20 minutes of classical massage on both lower extremities during hemodialysis in Period 1, and after a one-week washout period, 20 minutes of manual lymphatic drainage in Period 2.

20-minute MLD applied to both lower extremities (thigh, lower leg, and foot) one hour after the start of the hemodialysis session, using light, slow, rhythmic, superficial stroking, pumping, circular, and rotary maneuvers directed toward the inguinal, popliteal, and medial malleolar lymphatic regions.

20-minute classical massage applied to both lower extremities (thigh, lower leg, and foot) one hour after the start of the hemodialysis session, using effleurage, petrissage, and friction, beginning and ending with effleurage.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Időkeret
Standard Deviation of Normal-to-Normal Intervals (SDNN)
Időkeret: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Root Mean Square of Successive Differences (RMSSD)
Időkeret: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Low Frequency (LF) Power
Időkeret: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
High Frequency (HF) Power
Időkeret: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Low Frequency to High Frequency Ratio (LF/HF)
Időkeret: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Systolic Blood Pressure
Időkeret: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Diastolic Blood Pressure
Időkeret: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Heart Rate
Időkeret: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period
Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period

Másodlagos eredményintézkedések

Eredménymérő
Időkeret
Fatigue Subscale Score of the Profile of Mood States - Short Form
Időkeret: Before and immediately after the 20-minute intervention, in each intervention period
Before and immediately after the 20-minute intervention, in each intervention period
Vigor Subscale Score of the Profile of Mood States - Short Form
Időkeret: Before and immediately after the 20-minute intervention, in each intervention period
Before and immediately after the 20-minute intervention, in each intervention period
Tension Subscale Score of the Profile of Mood States - Short Form
Időkeret: Before and immediately after the 20-minute intervention, in each intervention period
Before and immediately after the 20-minute intervention, in each intervention period
Confusion Subscale Score of the Profile of Mood States - Short Form
Időkeret: Before and immediately after the 20-minute intervention, in each intervention period
Before and immediately after the 20-minute intervention, in each intervention period

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. november 24.

Elsődleges befejezés (Becsült)

2026. november 24.

A tanulmány befejezése (Becsült)

2027. szeptember 30.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. november 6.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. november 6.

Első közzététel (Tényleges)

2026. november 12.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. november 12.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. november 6.

Utolsó ellenőrzés

2026. november 1.

Több információ

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