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

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

Detailed Description
-----------------
36 people who will take part in the study will be assigned to intervention 1, intervention 2 and control groups. A patient in Intervention 1 (n=12) 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=12) 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.

Official Title
-----------------
The Effect of Lymphatic Drainage Massage on Interdialytic Weight Gain and Fatigue in Patients Undergoing Hemodialysis

Conditions
-----------------
Interdialytic Weight Gain, Fatigue

Intervention / Treatment
-----------------
* Other: lymphatic drainage massage
* Other: classic massage


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomized controlled clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lymphatic drainage massage<br>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. | Other: lymphatic drainage massage<br>* Before the application, the patient will be placed in a supine position and the feet will be elevated to 45 degrees by the researcher. After the infraclavicular lymph node, located at the point where the veins in the neck area meet the thymus gland, is stimulated with a pumping action, lower extremity applications will be started in the form of upper legs, lower legs and feet; By stimulating the inguinal lymph node in the upper leg application, the popliteal lymph node in the lower leg application, and the medial malleolus lymph node in the foot application, the mobility of the lymph fluid in the direction of the stimulated lymph node is used using stroking, pumping, circular movements or rolling movements according to the weight characteristic, body type and preference of the patient. will be provided. Finally, passive exercise will be performed 5 times, repeating both legs in flexion and extension positions, and the infraclavicular lymph node will be stimulated.<br>|
| Active Comparator: Classic massage<br>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. | Other: classic massage<br>* The application will be done 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 will be used. The application will start with efflorescence and end with the same technique. To the upper leg; Starting from the knee to the groin, to the lower leg; The application will be made in the direction of the muscle fibers, starting from the ankle to the knee. Appropriate techniques will be used depending on the characteristics of the application areas, and each technique will be repeated 5-10 times. In the final stage, passive exercise will be performed by moving to the foot and applying flexion and extension to the ankle 5 times. The application will be completed by applying similar applications to the upper and lower legs on the back of the foot and the outer and lower surface of the foot. Olive oil will be used as essential oil during application.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interdialytic weight gain | In hemodialysis centers, patients' weights are measured and recorded with an electronic scale by the healthcare personnel working in the institution before and after each hemodialysis session. Measurements are made by removing the patients' jackets/coats and shoes. The measurements will be recorded in kilograms by the researcher and weekly interdialytic weight gain will be evaluated. | Change before the application and in the 1st, 2nd, 3rd, and 4th weeks of the application | 
| Fatigue evaluated using the Fatigue Severity Scale | The Turkish validity and reliability of the scale, which was developed by Krupp et al. in 1989, was tested by Armutlu et al. in 2007, and the Cronbach's alpha coefficient was found to be 0.89, and the test-retest reliability was 0.81 (p = 0.719, within 99% confidence interval). The scale, which evaluates individuals' fatigue status in the last month, consists of a total of 9 items and each item is scored between 1-7. Strongly disagree = 1, moderately disagree = 2, somewhat disagree = 3, neither agree nor disagree = 4, somewhat agree = 5, moderately agree = 6, strongly agree = It is evaluated as 7 points. The total score calculation of the scale is calculated by adding up the scores given to each item to 9. It is done by dividing. The lowest score that can be obtained from the scale is 1 and the highest score is 7. A total score of 4 or more from the scale indicates severe fatigue. A higher score indicates increased fatigue. | Change before the application and 4th week of the application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure measurement | Blood pressure measurements of the patients will be taken before and after the application. A calibrated blood pressure monitor provided by the researcher will be used for all patients during measurements. Blood pressure measurements will be made and recorded at the dialysis center by healthcare personnel who are not involved in the research. The average systolic and diastolic blood pressure values of the patients will be calculated and evaluated weekly. | Change before the application and in the 1st, 2nd, 3rd, and 4th weeks of the application | 
| Evaluation of biochemical findings | With permission from the institutions and patients, previously performed laboratory tests will be evaluated and recorded retrospectively. From laboratory findings, albumin, urea, creatinine, sodium, potassium, calcium, phosphorus and urea clearance will be evaluated. | Change before the application and 4th week of the application | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interdialytic weight gain, Fatigue, Lymphatic drainage, Massage, Hemodialysis