The Effect of Lymphatic Drainage Massage on Interdialytic Weight Gain and Fatigue in Patients Undergoing Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- Fatigue evaluated using the Fatigue Severity Scale
研究概览
简要总结
The aim of this study is to evaluate the effect of lymphatic drainage massage on interdialytic weight gain and fatigue in patients undergoing hemodialysis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Individuals to be sampled will be assigned to groups according to the permutated block randomization method. Block size will be taken as 6. Random numbers will be generated in Excel by a researcher other than the researcher who collected the data, and a suitable number of blocks will be created for the sample. Assignment to groups will be made using the blocks of 6 corresponding to this number in the table. Index cards prepared in accordance with the assignment list will be placed in closed opaque envelopes and serial numbers will be written on them. The envelopes will be kept by a person who does not participate in the study and the assignment order will be learned from this person. The data will be recorded as coded as A, B and C, statistical analyzes will be carried out by the researcher who did not participate in the data collection phase according to this code, and the research report will be written in coded form.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Fatigue evaluated using the Fatigue Severity Scale
时间窗: 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
时间窗: 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.
次要结局
- Evaluation of biochemical findings(Change before the application and 4th week of the application)
- Blood pressure measurement(Change before the application and in the 1st, 2nd, 3rd, and 4th weeks of the application)
研究者
Ezgi ÖNEN EFECAN
Principal Investigator
Mersin University