Clinical Trials Directory

Trials / Completed

CompletedNCT06156371

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
75 (actual)
Sponsor
Mersin University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERlymphatic drainage massageBefore 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.
OTHERclassic massageThe 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.

Timeline

Start date
2023-11-11
Primary completion
2023-12-11
Completion
2024-11-23
First posted
2023-12-05
Last updated
2025-02-10

Locations

2 sites across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06156371. Inclusion in this directory is not an endorsement.