- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07932483
Manual Lymphatic Drainage Versus Classical Massage on Heart Responses and Mood in Hemodialysis
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Melike Davarci, BSN
- Telefonnummer: +905326515093
- E-post: d.melike_2002@icloud.com
Studiesteder
-
-
Mersin
-
Mersin, Mersin, Tyrkia (Türkiye), 33343
- Mersin University, Institute of Health Sciences
-
Ta kontakt med:
- Melike Davarci
- Telefonnummer: +905326515093
- E-post: d.melike_2002@icloud.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Standard Deviation of Normal-to-Normal Intervals (SDNN)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Fatigue Subscale Score of the Profile of Mood States - Short Form
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Before and immediately after the 20-minute intervention, in each intervention period
|
Before and immediately after the 20-minute intervention, in each intervention period
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Patologiske prosesser
- Mannlige urogenitale sykdommer
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Kronisk sykdom
- Sykdomsattributter
- Nyreinsuffisiens
- Patologiske tilstander, tegn og symptomer
- Nyresvikt, kronisk
- Terapeutikk
- Komplementære terapier
- Fysioterapi -modaliteter
- Rehabilitering
- Terapi, bløtvev
- Muskel- og skjelettmanipulasjoner
- Massasje
- Drenering
- Manuell lymfedrenasje
Andre studie-ID-numre
- 3715103
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .