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

NCT06156371 | Completed DMC

• 1 other identifier: Eonenefecan001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

Interdialytic Weight Gain; Fatigue

Keywords

Interdialytic weight gain; Fatigue; Lymphatic drainage; Massage; Hemodialysis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Blood pressure measurement

  Change before the application and in the 1st, 2nd, 3rd, and 4th weeks of the application

• Evaluation of biochemical findings

  Change before the application and 4th week of the application

Study Arms (3)

Lymphatic drainage massage

EXPERIMENTAL

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

Classic massage

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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.

Interventions

lymphatic drainage massage OTHER

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.

Lymphatic drainage massage

classic massage OTHER

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.

Classic massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (2)

Turkey, Mersin University

Mersin, Turkey (Türkiye)

Location

Mersin Nephrology Private Dialysis Center, Private Ata Dialysis Center, Private Diamer Dialysis Center and Private Mersin Dialysis Center'

Yenişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: prospective, randomized controlled clinical trial

Study Record Dates

• First Submitted: November 26, 2023
• First Posted: December 5, 2023
• Study Start: November 11, 2023
• Primary Completion: December 11, 2023
• Study Completion: November 23, 2024
• Last Updated: February 10, 2025

Record last verified: 2024-01

Locations

TU (2)