- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06604403
Effectiveness of Massage Applied to Hemodialysis Patients
September 17, 2024 updated by: Zeynep Yildirim
Effect of Massage Applied to Hemodialysis Patients on Comfort Level and Fatigue
This study was conducted to determine the effect of massage on comfort and fatigue levels of hemodialysis patients.
Study Overview
Detailed Description
Chronic renal failure (CRF) is a health problem that causes significant mortality and morbidity worldwide.
The prevalence of the disease is increasing worldwide, especially in developing countries.
Hemodialysis (HD) is the most common treatment method for CRF in the world.
Approximately 90% of patients with CRF receive HD treatment.
Despite advances in technology and medical care due to HD treatment, patients experience many physical and psychosocial symptoms.
It is emphasized that comfort is significantly negatively affected in HD patients due to reasons such as the direct impact of HD treatment on the daily and social lives of patients.
Increasing the comfort level is important for the patient to continue their daily life activities.
In addition, comfort is accepted as the basis of quality nursing care.
Increasing the comfort levels of HD patients provides lower comorbidity and mortality rates and improvement in institutional patient outcomes.
Fatigue, one of the physical symptoms seen in HD patients, affects 60-95% of patients.
Fatigue increases the patients' dependency levels, reduces their physical capabilities, negatively affects the patient and their family economically and reduces their quality of life.
Therefore, effective management of fatigue is of great importance for the patient.
Despite affecting the patients' lives to this extent, fatigue and discomfort have often been overlooked and neglected symptoms due to their subjective nature.
Various pharmacological and non-pharmacological treatment methods are used to control fatigue due to CRF or HD and to bring the desired patient comfort.
One of the non-pharmacological methods is massage.
Massage can be defined as scientific systematic manipulations applied to body tissues in order to affect the locomotor system and nervous system as well as the general circulation.
There are studies in the literature where various applications are applied to HD patients to affect fatigue and comfort.
However, it is striking that there is no study examining the effect of massage on the comfort and fatigue levels of patients receiving HD treatment.
Therefore, the research was planned to examine the effect of massage on the comfort level and fatigue level of HD patients.
Study Type
Interventional
Enrollment (Estimated)
58
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zeynep YILDIRIM, Res. Ass.
- Phone Number: 05365978465
- Email: zeynepyildirim@atauni.edu.tr
Study Contact Backup
- Name: Mağfiret KAŞIKÇI, Prof. Dr.
- Phone Number: 05327839114
- Email: magfiret@atauni.edu.tr
Study Locations
-
-
Yakutiye
-
Erzurum, Yakutiye, Turkey, 25100
- Recruiting
- Ataturk University
-
Contact:
- Zeynep YILDIRIM
- Phone Number: 05365978465
- Email: zeynepyildirim@atauni.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Volunteering to participate in the study
- Being 18 years of age or older
- Receiving hemodialysis treatment in a dialysis unit for at least six months
- Not having a condition that prevents verbal communication
- Not having a psychiatric problem
Exclusion Criteria:
- Patients who left the study at any stage
- Patients who had been receiving hemodialysis treatment for less than 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Massage Group
Patients in the intervention group will receive post-hemodialysis massage twice a week for four weeks.
|
After the hemodialysis, the patients will receive a 15-20 minute hand and foot massage.
This application will be applied to the patients in two weekly dialysis sessions for a total of 8 sessions for four weeks.
Before starting the massage applications, the patient's hands and feet will be washed and dried thoroughly.
The patients will be given a semi-sitting or lying position that they can feel comfortable in.
Before starting the hand and foot massage, the researcher will gently rub and warm their hands and wrists.
The massages will start with a hand massage.
A foot massage will be performed after the hand massage.
3-5 drops of baby oil applied at room temperature will be used to reduce friction during the massage.
Effleurage, petrissage and friction styles of the massage will be applied.
|
|
No Intervention: Control Group
Routine nursing care was given to the patients in this group without any message.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hemodialysis Comfort Scale
Time Frame: Up to 4 weeks
|
The scale developed by Sahin Orak and his colleagues in 2017 consists of nine items and two sub-dimensions.
These sub-dimensions are; "Relaxation" (7-9) and "Overcoming" (1- 6).
The scale is a five-point Likert type (1: never -5: always).
Items 1-3 and 5-9 of the scale are reverse coded.
The lowest score that can be obtained from the scale is 9, the highest score is 45.
The higher the score, the higher the comfort level.
|
Up to 4 weeks
|
|
Piper Fatigue Scale
Time Frame: Up to 4 weeks
|
The scale was developed by Barbara F. Piper and her friends in 1987 and adapted to Turkish by Can and her friends in 2001.
The scale consists of 22 items and four sub-dimensions.
These are; "Behavior/Violence" (2-7); "Affect" (8-12), "Sensory" (5 items; 13-17) and "Cognitive/Psychological" (18-23).
In addition to this, there are five items (1 and 24-27) that are not used in calculating the fatigue score, but are recommended to remain in the scale because they are important in evaluating data related to fatigue.
The scale is evaluated using a 0-10 Vizuel Analog Scale.
The total score obtained from the scale is divided by the number of items.
The minimum score that can be obtained from the scale is 0, and the maximum score is 10.
The higher the score, the more fatigue the individual feels.
|
Up to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 10, 2022
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
September 17, 2024
First Submitted That Met QC Criteria
September 17, 2024
First Posted (Estimated)
September 19, 2024
Study Record Updates
Last Update Posted (Estimated)
September 19, 2024
Last Update Submitted That Met QC Criteria
September 17, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Massage
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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