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Not Yet Recruiting NCT07932483

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

Conditions: Renal Dialysis, Renal Insufficiency, Chronic, Manual Lymphatic Drainage, Massage, Affect (Mental Function)

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Mersin University

Location: Mersin University, Institute of Health Sciences Mersin Mersin

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07932483). StuddyBuddy aggregates publicly available trial information.