The Effect of Lymphatic Drainage Massage on Interdialytic Weight Gain and Fatigue
- Conditions
- FatigueInterdialytic Weight Gain
- Interventions
- Other: lymphatic drainage massageOther: classic massage
- Registration Number
- NCT06156371
- Lead Sponsor
- Mersin University
- 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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lymphatic drainage massage lymphatic drainage massage 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. Classic massage classic massage 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.
- Primary Outcome Measures
Name Time Method Fatigue evaluated using the Fatigue Severity Scale Change before the application and 4th week of the application 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.Interdialytic weight gain Change before the application and in the 1st, 2nd, 3rd, and 4th weeks of the application 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.
- Secondary Outcome Measures
Name Time Method Evaluation of biochemical findings Change before the application and 4th week of the application 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.
Blood pressure measurement Change before the application and in the 1st, 2nd, 3rd, and 4th weeks of the application 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.
Trial Locations
- Locations (2)
Turkey, Mersin University
🇹🇷Mersin, Turkey
Mersin Nephrology Private Dialysis Center, Private Ata Dialysis Center, Private Diamer Dialysis Center and Private Mersin Dialysis Center'
🇹🇷Yenişehir, Turkey