The Effect of Acupressure on Fatigue, Quality of Life and Comfort in Hemodialysis Patients. Randomized Controlled Study
Phase: NA
Conditions: Fatigue, Comfort, Quality of Life
Sponsor: Mersin University

NCT Number: 05892679 
The Effect of Acupressure on Fatigue, Quality of Life and Comfort in Hemodialysis Patients. Randomized Controlled Study 
 
 
 
Document Date: 12 June 2023 
 
Title of The Study: The Effect of Acupressure on Fatigue, Quality of Life and Comfort in 
Hemodialysis Patients. Randomized Controlled Study 
 
NCT Number: 05892679 
 
Document: The Study Protocol and Statistical Analysis Plan 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

NCT Number: 05892679 
The Effect of Acupressure on Fatigue, Quality of Life and Comfort in Hemodialysis Patients. Randomized Controlled Study 
 
 
STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN 
1. Title of the Study: The Effect of Acupressure on Fatigue, Quality of Life and Comfort in 
Hemodialysis Patients. Randomized Controlled Study 
2. Purpose of the Study: In this study, it was aimed to determine the effect of acupressure on 
fatigue, quality of life and comfort in hemodialysis patients. In our research, it is aimed to reduce fatigue, 
increase the quality of life and comfort level in hemodialysis patients with acupressure applied. 
3. Rationale for the Study: Literature was associated acupressure with fatigue (1-10), pain (11), 
pruritus (12), sleep problems (4,13-17), depression (7,8,18), in hemodialysis patients and chronic kidney 
disease patients. It has been reported acupressure to be effective in controlling many symptoms such as 
nausea-vomiting, muscle cramps (19) and itching (20). In the literature, it is noted that acupressure has a 
positive effect on the fatigue symptoms of hemodialysis patients. Studies have shown that hemodialysis 
patients experience high levels of fatigue, and fatigue is the most common factor in patients with CKD, 
significantly affecting their daily living activities and quality of life (1,2,5,20-22). 
Studies on fatigue, quality of life and comfort of acupressure in hemodialysis patients are limited 
in the literature. However, there is no study in the literature examining the effects of acupressure on 
fatigue, quality of life and comfort in hemodialysis patients. High-quality, randomized controlled studies 
with sufficient sample size are needed to demonstrate the effect of acupressure in hemodialysis patients. 
There is no other randomized controlled study examining the effects of acupressure application on fatigue, 
quality of life and comfort in hemodialysis patients planned to be included in our study. 
Therefore, in this study, it was aimed to draw attention to the importance of acupressure by 
revealing the effect of acupressure on comfort and quality of life in individuals who experience fatigue 
due to hemodialysis. It is thought that independent nursing initiatives will be supported with acupressure 
to be applied in the research, and it will contribute to the practices of nurses. In addition, the adoption of 
the results of our research by hospital administrations as an institutional policy will guide the care of 
nurses. 
4. Research Materials and Methods: 
The study is planned as a prospective, single-blind randomized controlled randomized study to 
determine the effect of acupressure on fatigue, quality of life and comfort in hemodialysis patients. This 
randomized controlled trial will be reported according to CONSORT guidelines and registered on 
ClinicalTrials.gov (23). 
Patients who receive hemodialysis treatment in Adana City Hospital dialysis unit, volunteer to 
participate in the study and meet the research criteria, will be assigned to the study and control groups 
according to the days they come for dialysis treatment by lottery method (coin toss). Heads will be 
determined as the working group and heads will be determined as the control group. Randomization in 
the study will be done on the website of randomizer.org and patients will be included in the study and 
control groups with the appropriate randomization method according to the dialysis unit list (12,24). 

NCT Number: 05892679 
The Effect of Acupressure on Fatigue, Quality of Life and Comfort in Hemodialysis Patients. Randomized Controlled Study 
 
The data obtained from the research will be evaluated using appropriate statistical methods. In the 
analysis of comparative data, parametric or nonparametric tests will be used by evaluating the conformity 
to the normal distribution. A package program will be used in the statistical analysis of the research. 
4.1. Statistical analysis 
 Demographic and patient-reported results in the study will be summarized with descriptive 
statistics. Continuous, normality checks of measurements will be tested with the Shapiro Wilk test. 
Differences in repeated measures between groups will be tested with the Repeated Measures test (repeated 
measure analysis of variance). Bonferronni test will be used for pairwise comparisons. Differences 
between groups for each measurement will be tested with the Independent Samples t-test. Number and 
percentage values will be given as descriptive statistics. Pearson chi-square and Fisher Exact chi-square 
tests will be used for differences between categorical variables. Number and percentage values will be 
given as descriptive statistics. P<0.05 will be taken as statistical significance. 
4.2. Research Design: Prospective  
4.3. Design of the Research 
The population of the research will be hemodialysis patients treated at Adana City Hospital 
between 30 May 2023 and 30 September 2023. The research sample will consist of patients who meet the 
research criteria and agree to participate voluntarily in the research. The sample number of the study was 
calculated using the G*Power 3.1.9.7 program (25). In the calculation, a sample calculation was made for 
repeated measures ANOVA test. In the calculation, Cohen's medium effect size (f = 0.5), 5% margin of 
error (α = 0.05) and 95% power (1-β = 0.95) and the correlation value between repeated measurements 
were taken as 0.50 for each group (study and control). ) sample size was calculated as 21 patients (42 
patients in total). Considering the possibility of patients leaving the groups during the research process, 
the number of samples for each group was increased by 30%, taking into account the possibility of data 
loss in order not to adversely affect the statistical power, and 30 patients (total of 60 patients) for each 
group (study and control) were included in the sample planned (26). Randomization in the study will be 
done on the website of randomizer.org and patients will be included in the study and control groups with 
the appropriate randomization method according to the dialysis unit list (27). 
F tests - ANOVA: Repeated measures, between factors 
Analysis: 
A priori: Compute required sample size  
Input: 
 
 
Effect size f 
= 0.5 
 
α err prob 
= 0.05 
 
Power (1-β err prob) 
= 0.95 
 
Number of groups 
= 2 
 
Number of measurements 
= 2 
 
Corr among rep measures 
= 0.5 
Output: 
 
 
Noncentrality parameter λ 
= 14.0000000 
 
Critical F 
= 4.0847457 
 
Numerator df 
= 1.0000000 
 
Denominator df 
= 40.0000000 
 
Total sample size 
= 42 
 
Actual power 
= 0.9545279 
In the study, 60 hemodialysis patients were randomly assigned to the study and control groups. 
The study group (n=30) Acupressure is formulated according to the standards of the World Health 

NCT Number: 05892679 
The Effect of Acupressure on Fatigue, Quality of Life and Comfort in Hemodialysis Patients. Randomized Controlled Study 
 
Organization and in a certain order to the points of Stomach 36 (St 36), Gall Bladder 34 point (GB 34), 
Spleen 6 point (SP 6) and Kidney 1 point (K 1) will be applied. Consideration will be given to the 
appropriate pressure intensity and duration. Since the reactions of individuals will be different from each 
other, the stiffness and pressure will be adjusted according to the sensitivity of the individual in order not 
to cause tissue damage. Pressures will be applied manually by a single practitioner. Considering the 
anatomical area where the point is located, the most suitable thumb, index and/or middle finger will be 
used for application to the relevant point. Successive compressions will be applied at a frequency that 
does not disturb the patient, does not cause pain, and has a calming effect.  
Considering the studies done, a person will be given acupressure three times a week for four weeks. 
No intervention will be made to the control group (n=30). In order to avoid ethical problems both groups 
will be given an informative training on acupressure and fatigue, increase the quality of life and comfort 
level in hemodialysis patients at the end of the study. The primary outcome of the study is the effect of 
acupuncture on fatigue in hemodialysis patients. The secondary result of the study is the effect of 
acupuncture on quality of life and comfort level in hemodialysis patients. 
The results will be collected before the acupressure and in the 4th week of the last intervention. 
 
Table 1. Application Points Used in the Study (33) 
Application Site 
Name 
Picture of Application Site 
Description of 
Application Site 
Stomach 36. point 
 
(Zusanli: ST 36) 
 
In the leg, it is one 
finger width lateral to 
the anterior crest of 
the tibia, and 3 cuns 
below the ST 35 in 
the depression on the 
lateral side of the 
patella. 
 

NCT Number: 05892679 
The Effect of Acupressure on Fatigue, Quality of Life and Comfort in Hemodialysis Patients. Randomized Controlled Study 
 
Gall Bladder 34. 
point 
(GB 34 or 
Yangligquan) 
 
It is located on the 
lateral side of the leg, 
in the lower anterior 
depression of the head 
of the fibula. 
 
Spleen 6. point 
(Sanyinjiao: SP 6) 
 
It is located on the 
medial leg, 3 cuns 
above the medial 
malleolus, at the 
posterior border of the 
tibia. 
Kidney 1. Point  
(K 1) 
 
It is located between 
the 2nd and 3rd 
metatarsal bones on 
the sole of the foot (in 
the front of 1/3 when 
we divide the sole of 
the foot into 3 parts). 
 
 
 
 
 

NCT Number: 05892679 
The Effect of Acupressure on Fatigue, Quality of Life and Comfort in Hemodialysis Patients. Randomized Controlled Study 
 
5. Research Flow Process 
The Flow Chart of this research will be completed in three stages and four steps as indicated in 
Figure 1. 
First Stage (Preparatory Stage): An internationally approved acupressure certificate was 
obtained by the researcher in July 2022 (the certificate is in Annex I). The place where the acupressure 
application will be made will be arranged in accordance with the acupressure application. Necessary 
materials will be purchased for acupressure application (bed cover, pillow, etc.) 
 
Second Stage (Implementation Stage): This stage will consist of four steps.   
In the first step: In the first step of the application, patients who receive hemodialysis treatment 
in Adana City Hospital dialysis unit and meet the research criteria and are willing to participate in the 
research will be given brief information about the research and their verbal consent will be obtained. The 
fatigue experience VAS scores of the patients who accepted to participate in the study on a voluntary basis 
will be calculated. Those with a VAS value of fatigue severity ≥ 4.0 between 0 and 10 points will constitute 
the sample of the study. 
In the second step: Sample selection will be completed in accordance with the inclusion, 
exclusion and exclusion criteria of the study, and then randomization will be performed. The patients will 
be informed about the purpose of the research and the research process, and the patients will be asked to 
fill in the "Piper Fatigue Scale", "Kidney Disease and Quality of Life Form" and "Hemodialysis Comfort 
Scale" as a pre-test with an informed consent form. 
Third step: Patients in the study group will be given a total of 12 sessions of acupressure 
application bilaterally to Stomach 36 (St36), Gall Bladder 34 (GB34), Spleen 6 (SP6) and Kidney 1 (K1) 
acupuncture points for 4 weeks and 3 days a week for 20 minutes. No intervention will be made to the 
control group other than routine maintenance during the four-week period. 
Fourth step: After the 4-week acupressure process is over, after the last acupressure session, the 
patients in the study group will have the "Piper Fatigue Scale", "Kidney Disease and Quality of Life Form" 
and "Hemodialysis Comfort Scale" filled face-to-face as a post-test. At the end of 4 weeks, the control 
group will have to fill in the “Piper Fatigue Scale”, “Kidney Disease and Quality of Life Form” and 
“Hemodialysis Comfort Scale” as a post-test before hemodialysis. 
 
Third Stage (Reporting Stage): At this stage Statistical analysis of the data obtained from the 
patients will be made and a research report will be written. 
 
 
 
 
 

NCT Number: 05892679 
The Effect of Acupressure on Fatigue, Quality of Life and Comfort in Hemodialysis Patients. Randomized Controlled Study 
 
Figure 1. Flow Chart of the Research 
STAGE 1. 
PREPARATION 
STAGE  
Arrangement of Adana City Hospital dialysis unit in accordance with acupressure 
application in order to perform acupressure application. 
STAGE 2 IMPLEMENTATION PHASE 
1. Step 
Contacting patients receiving hemodialysis treatment in Adana City 
Hospital dialysis unit,  
Determining compliance with the criteria, 
Measuring fatigue experience VAS scores, 
Recruiting patients willing to participate in the study 
2. Step 
Determining the sample according to the criteria 
Performing the randomization 
(Study Group; n=30 - Control Group; n=30) 
Getting Informed Consent and pre-test data collection forms 
(“Patient Description Form”, “Piper Fatigue Scale”, “Kidney Disease and 
Quality of Life Form” and “Hemodialysis Comfort Scale”) 
3. Step 
Making acupressure group (n=30) 
apply acupressure for 20 minutes 
three times a week for four weeks. 
No intervention in the control 
group (n=30) 
4. Step 
Having the study group (n=30) fill 
out the post-test data collection 
forms (“Piper Fatigue Scale”, 
“Kidney Disease and Quality of Life 
Form” and “Hemodialysis Comfort 
Scale”) after the last acupressure 
session, after the 4-week 
acupressure process is over. 
The control group  to be fill out the 
post-test data collection forms 
(“Piper Fatigue Scale”, “Kidney 
Disease and Quality of Life Form” 
and “Hemodialysis Comfort Scale”) 
at the end of the interview at the 
end of 4 weeks. 
STAGE 3 
REPORTING 
PHASE 
ANALYSIS OF DATA AND WRITTEN RESEARCH REPORT 
 
 
 

NCT Number: 05892679 
The Effect of Acupressure on Fatigue, Quality of Life and Comfort in Hemodialysis Patients. Randomized Controlled Study 
 
5. Data Collection Tools of the Research 
“Data Collection Form” will be used in the data collection phase of the research. 
5.1. Data Collection Form 
In the study, data will be collected with a data collection form consisting of four parts: "Patient 
Description Form", "Piper Fatigue Scale", "Kidney Disease and Quality of Life Form (KDQOLTM-36)" 
and "Hemodialysis Comfort Scale". 
 
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NCT Number: 05892679 
The Effect of Acupressure on Fatigue, Quality of Life and Comfort in Hemodialysis Patients. Randomized Controlled Study 
 
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NCT Number: 05892679 
The Effect of Acupressure on Fatigue, Quality of Life and Comfort in Hemodialysis Patients. Randomized Controlled Study 
 
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NCT Number: 05892679 
The Effect of Acupressure on Fatigue, Quality of Life and Comfort in Hemodialysis Patients. Randomized Controlled Study 
 
ANNEX I