ClinicalTrials.gg
Not yet recruitingNCT07932483Updated Nov 12, 2026

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

An interventional study of Manual Lymphatic Drainage and Classical Massage in Renal Dialysis, Renal Insufficiency, Chronic and Manual Lymphatic Drainage, sponsored by Mersin University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Mersin University · Not applicable, Interventional, and Supportive care

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 112 studies in Renal Insufficiency, Chronic with a site in Turkey — 20 open to participants now, 30 under way, 14 of them phase 3. Renal Insufficiency, Chronic · Turkey.

Planned enrollment
63rd of 81
60 · median 121
Started
2026
with 4 others
No phase
37 of 112
2 open now
Primary completion
2026-11
later than 12 of 29 live
Registered
111th of 112
by date

Among the 112 studies in Renal Insufficiency, Chronic with a site in Turkey, this one is the 63rd largest by planned enrollment of the 81 interventional ones that give a count, is one of 5 that started in 2026, is one of 37 with no phase, reaches primary completion later than 12 of the 29 other live ones, and was the 111th registered.

Renal Insufficiency, Chronic

3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.

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Open to participants now

20 of the 112 studies in Renal Insufficiency, Chronic with a site in Turkey are open now. Recruiting first, the newest first:

14 more — sign in →

All 20 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 435 Renal Insufficiency, Chronic studies recruiting now, 245 (56%) set no upper age limit and 111 (26%) stop at 75 or younger; 45 take children under 18; 80 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

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02

Study summary

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.
Read the detailed description

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.

03

Conditions studied

  • Renal Dialysis
  • Renal Insufficiency, Chronic
  • Manual Lymphatic Drainage
  • Massage
  • Affect (Mental Function)
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    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.

    Other: Manual Lymphatic Drainage · Other: Classical Massage

  • Experimental
    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.

    Other: Manual Lymphatic Drainage · Other: Classical Massage

Interventions

  • OtherManual Lymphatic Drainage

    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.

  • OtherClassical Massage

    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.

06

What researchers measure

Primary outcomes

  1. Standard Deviation of Normal-to-Normal Intervals (SDNN)

    Time frame: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period

  2. Root Mean Square of Successive Differences (RMSSD)

    Time frame: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period

  3. Low Frequency (LF) Power

    Time frame: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period

  4. High Frequency (HF) Power

    Time frame: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period

  5. Low Frequency to High Frequency Ratio (LF/HF)

    Time frame: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period

  6. Systolic Blood Pressure

    Time frame: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period

  7. Diastolic Blood Pressure

    Time frame: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period

  8. Heart Rate

    Time frame: Before the intervention, immediately after the 20-minute intervention, and 30 minutes after the post-intervention measurement, in each period

Secondary outcomes

  1. Fatigue Subscale Score of the Profile of Mood States - Short Form

    Time frame: Before and immediately after the 20-minute intervention, in each intervention period

  2. Vigor Subscale Score of the Profile of Mood States - Short Form

    Time frame: Before and immediately after the 20-minute intervention, in each intervention period

  3. Tension Subscale Score of the Profile of Mood States - Short Form

    Time frame: Before and immediately after the 20-minute intervention, in each intervention period

  4. Confusion Subscale Score of the Profile of Mood States - Short Form

    Time frame: Before and immediately after the 20-minute intervention, in each intervention period

07

Study locations

1 site
  • Mersin University, Institute of Health Sciences
    Mersin, Mersin 33343, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2026, 0 months later.

Of 576 non-industry interventional studies with no phase under Renal Insufficiency, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 0 months is below that.

Counting every sponsor, half of 616 studies reached it within 23 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2026
First posted
Nov 12, 2026
StartEst.
Nov 24, 2026
Primary completionEst.
Nov 24, 2026
CompletionEst.
Sep 30, 2027
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07932483
Lead sponsor
Mersin University
Responsible party
Melike Davarcı (Nurse, Mersin University) — Principal investigator
First posted
Nov 12, 2026
Start date
Nov 24, 2026 (estimated)
Primary completion
Nov 24, 2026 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Nov 12, 2026

Study contacts

Melike Davarci, BSN
Contact
d.melike_2002@icloud.com
+905326515093

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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