The Effect of Lymphatic Drainage Massage on Interdialytic Weight Gain and Fatigue (MLD)

Mersin University

Status: Completed

Conditions: Interdialytic Weight Gain; Fatigue

Treatments: Other: lymphatic drainage massage; Other: classic massage

Study type: Interventional

Funder types: Other

Identifiers

NCT06156371

Eonenefecan001

Details and patient eligibility

About

The aim of this study is to evaluate the effect of lymphatic drainage massage on interdialytic weight gain and fatigue in patients undergoing hemodialysis.

Full description

Since there is no similar study in the literature, a preliminary application was made to determine the sample size. According to the inclusion criteria, after reaching a total of 36 people, namely Intervention I = 12, Intervention II = 12 and control group = 12, a power analysis was performed, and the minimum sample size to be taken with 5% type 1 error and 80% power was determined as 60 people. Considering that there might be a 25% loss in the sample, it was decided to include 25 people in the Intervention I group, 25 in the Intervention II group and 25 in the control group, making a total of 75 people, namely Intervention I = 25, Intervention II = 25, Control = 25.36 people. A patient in Intervention 1 (n=25) group will receive a lymphatic drainage massage for 20 minutes a day, 3 days a week, a total of 12 times for 4 weeks. The application will start 1 hour after the patient enters hemodialysis. Before the application, the patient will be placed in a supine position and the researcher will ensure that the feet are elevated to 45 degrees for the application to be effective. In practice, after the infraclavicular lymph node, which is located at the point where the veins in the neck area meet the thymus gland and called the "main terminal" lymph node, is stimulated with a pumping action, lymphatic drainage will be applied to the upper legs, lower legs and feet. A patient in Intervention 2 (n=25) group will receive classical massage on the upper legs, lower legs and feet for 15 minutes a day, 3 days a week, a total of 12 times for 4 weeks. The application will start 1 hour after the patient enters hemodialysis. No intervention other than the first and last evaluation will be applied to the control group. At the end of the study, participants will be given full information, stating that they were not informed about the specific purpose of the study for scientific reasons. The effect of lymphatic drainage massage on interdialysis weight gain and fatigue are the primary outcomes of the study. The effect of lymphatic drainage massage on blood pressure and laboratory findings are secondary outcomes of the study. The results will be collected before and after intervention in the 1st, 2nd, 3rd and 4th weeks.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Hemodialysis at Private Ata Dialysis Center, Private Diamer Dialysis Center, Mersin Nephrology Private Dialysis Center and Private Mersin Dialysis Center between 30.11.2023-30.06.2024 coming for treatment,
• Receiving hemodialysis treatment 3 times a week for at least 6 months,
• The average interdialytic weight gain in the last 3 sessions exceeds 4% of the dry weight,
• Volunteer to participate in the research and
• Individuals who can speak and understand Turkish will be included in the research.

Exclusion criteria

• Using insulin,
• Diagnosed with malignant tumor,
• Having deep vein thrombosis and heart failure diagnosed by a physician,
• Those with missing limbs or infected, open wounds in the application areas,
• Pregnant and
• Individuals who are in another complementary treatment program will not be included in the study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups

Lymphatic drainage massage

Experimental group

Description:

In the lymphatic drainage massage group, a patient will receive a total of 12 treatments, 20 minutes a day, 3 days a week for 4 weeks. Face-to-face manual lymphatic drainage massage will be performed at least 1 hour after the patient starts hemodialysis treatment, according to the morning and afternoon work schedules of the institutions. Manual lymphatic drainage massage will be performed by a certified researcher in accordance with the application steps.

Treatment:

Other: lymphatic drainage massage

Classic massage

Active Comparator group

Description:

A patient in the classical massage group will receive a total of 12 treatments, 15 minutes a day, 3 days a week for 4 weeks. The classical face-to-face massage application will be performed at least 1 hour after the patient starts hemodialysis treatment, according to the morning and afternoon work schedules of the institutions. Classical massage application will be performed by the researcher. The order of application is upper leg, lower leg and feet. During the application, appropriate methods such as effleurage (stroking), kneading, friction, impact and vibration, which are frequently used in classical massage, will be used. Olive oil will be used as essential oil during application.

Treatment:

Other: classic massage

Control

No Intervention group

Description:

No intervention other than the first and last evaluation will be applied to the control group. Patients in this group will continue to receive their usual hemodialysis treatment and care.