Clinical trial NCT06156371: The Effect of Lymphatic Drainage Massage on Interdialytic Weight Gain and Fatigue
Official title: The Effect of Lymphatic Drainage Massage on Interdialytic Weight Gain and Fatigue in Patients Undergoing Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interdialytic Weight Gain
Fatigue
Keywords: Interdialytic weight gain
Fatigue
Lymphatic drainage
Massage
Hemodialysis
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Interdialytic weight gain
timeFrame: Change before the application and in the 1st, 2nd, 3rd, and 4th weeks of the application
measure: Fatigue evaluated using the Fatigue Severity Scale
timeFrame: Change before the application and 4th week of the application
Secondary outcomes:
measure: Blood pressure measurement
timeFrame: Change before the application and in the 1st, 2nd, 3rd, and 4th weeks of the application
measure: Evaluation of biochemical findings
timeFrame: Change before the application and 4th week of the application
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Turkey, Mersin University
city: Yenişehir
country: Turkey
facility: Mersin Nephrology Private Dialysis Center, Private Ata Dialysis Center, Private Diamer Dialysis Center and Private Mersin Dialysis Center'
Study officials:
References: