Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05833750 |
| Other study ID # |
haticeguzel |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2020 |
| Est. completion date |
June 18, 2021 |
Study information
| Verified date |
April 2023 |
| Source |
Sanko University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Abstract Objective: The aim of this study is to examine the effect of reflexology on fatigue
in kidney transplant patients.
Design: The study will be conducted as randomized, controlled and experimental. Method: The
data of the research will be collected in the transplant clinic of a foundation university
practice and research hospital between 07.12.2020 - 18.06.2021.
While the population of the study consisted of 254 patients who underwent kidney
transplantation in the transplant unit, 68 patients were included in the sample. The patients
included in the study were divided into reflexology (n=34) and control (n=34) groups with the
help of a program. Data will be collected using Questionnaire and Piper Fatigue Scale.
Chi-square test, Student's t test, Mann Whitney U test and Kruskal-Wallis test, correlation,
generalized estimation equation and Least Significant Difference tests will be used in the
evaluation of the data.
Keywords: kidney transplantation, reflexology, fatigue, nursing.
Description:
Chronic kidney failure (CKD), the incidence of which continues to increase day by day and
causes serious health problems in Turkey as in the world, maintains its current status as an
important health problem. In the Chronic Kidney Diseases Prevalence (CREDIT) study in Turkey
conducted by the Turkish Society of Nephrology (TSN), the incidence of CRF was found to be
15.7%, and the incidence of advanced stage CRF was 5.2%. As it is known, when this health
problem reaches the stage of end-stage renal disease (ESRF), one of the renal replacement
therapies (RRT) is absolutely needed.
Among the commonly used RRTs today are hemodialysis (HD), peritoneal dialysis (PD) and kidney
transplantation (RTx). It has been reported that the best treatment option in terms of
quality of life and patient survival is RTx. This is because a successful RTx significantly
reduces the risk of mortality and morbidity compared to dialysis. According to the 2020 data
of the Ministry of Health, HD was applied to 72.66% of the patients who received RRT, PD to
4.06% and RTx to 23.28%. According to the National Nephrology, Dialysis and Transplant
Registration System Report, the number of RTx from live donors in Turkey in 2020 is 2,250
(90.04%), the number of RTx from cadavers is 249 (9.96%), this number is 2,499 in total.
2. BACKGROUND It is known that patients with ESRD likely experience a range of symptoms
including nausea, vomiting, pain and fatigue. Therefore, patients prefer RTx more to stop
dialysis and maintain a normal life. However, it is stated in the literature that fatigue
continues after RTx. Fatigue is a subjective problem that affects individuals physically and
psychologically and impairs their quality of life. For this reason, it is very important for
nurses who are in constant communication with the patient to evaluate this symptom and to
plan and implement appropriate nursing interventions. In this respect, it is recommended to
use evidence-based approaches in the prevention and management of fatigue, to repeat the
personalized training program at certain intervals, and to use integrative methods that can
facilitate coping with fatigue. Exercise, yoga, acupressure and reflexology are among the
most preferred integrative methods today. Different studies have reported that patients
benefit from reflexology to reduce fatigue.
Reflexology is the method of applying physical pressure to all body parts, organs and reflex
points corresponding to the endocrine glands in the ears, hands and feet, which are accepted
as the mirror of the body, using certain finger and hand techniques. It has been reported
that this approach facilitates relaxation, releases endorphins, modulates pain transmission
and pain perception, regulates blood circulation and hemodynamic variables, and improves
sleep quality. However, when the literature is examined, it has been seen that there are a
limited number of studies evaluating the effect of reflexology in the management of fatigue
after RTx. For this reason, this study was conducted to evaluate the effect of reflexology
applied to patients who underwent RTx on fatigue, to contribute to fatigue management and to
form a basis for future research.
3 STUDY 3.1 Purpose This study will be conducted to examine the effect of reflexology applied
to kidney transplant patients on fatigue.
The Hypothesis of the Study Hypothesis -0 (H0): Reflexology applied to renal transplant
patients does not reduce fatigue.
Hypothesis -1 (H1): Reflexology applied to renal transplant patients reduces fatigue.
3.2 Design The data of this randomized, controlled and experimental study will be obtained
from patients admitted to the Organ Transplant Clinic of a Foundation University Hospital.
Power analysis will be used to determine the sample size of the study.
3.3 Participants The population of the study consisted of 254 patients who underwent RTx in
the Organ Transplant Unit. According to the power analysis, with the medium effect size
(dz=0.5) and the minimum sample size required for the before-after comparison, it was planned
to include a total of 68 patients, 34 per group, and the study will be completed with 68
patients. After the pre-test data of 68 patients who accepted to participate in the study
were collected by the researcher, two groups will be randomly created by randomization method
in the computer program based on the Piper Fatigue Scale (PFS) total scores. After the first
patient is selected to one of the groups, the second patient will be automatically assigned
to the second group. Assignment will continue until the blocks in each group are equal.
Patients who volunteered to participate in the study, aged 18-75, had a kidney transplant,
had a PFS score of 1 and above, had no communication problems, had a kidney transplant and
were discharged from the hospital for at least 3 months. residing in the province where the
research was conducted, will be included in the study. Patients who scored 0 on PFS, had open
foot wounds, fractures, burns, and suspected thrombocytopenia, were diagnosed with deep vein
thrombosis and peripheral neuropathy by the physician, and did not volunteer to participate
in the study will be excluded from the study. The application will continue by assigning new
patients to replace the withdrawn patients. Data collection tools will be applied after the
patients included in the study are informed about the purpose of the study and the
application stages. Participants in both patient groups will have informed consent forms
signed.
3.4.1 Application of Data Collection Tools The researcher and the responsible physician of
the relevant clinic received certification training in reflexology before the study. PFS will
be applied to patients in both groups. As a result of the literature review, a total of 16
sessions of reflexology lasting 30 minutes each will be applied twice a week for eight weeks.
At the end of the first month and the second month, PFS will be applied again to the patients
in both groups. In addition, a session of reflexology will be applied to the patients in the
control group after PFS is applied for the third time.
3.4.2 Reflexology Practice The patient will be taken to a single room with a bathroom in the
transport unit for reflexology practice, considering his own privacy. The patient will lie on
the bed after washing his feet in the bathroom and drying them with a paper towel. He will be
placed in a semi-winged or supine position supporting his neck, waist and knees. The
practitioner will wash their hands and rub them with some vaseline so that they have body
temperature. He will then start reflexology with his right foot and continue to practice with
his left foot. He will do the following methods for five minutes to warm his feet; Rotation
and stretching of the Achilles tendon, bilateral ankle relaxation, and swelling from heel to
toes and then from top of foot to ankle. During the application, the pressure with one hand
will be supported by the other hand and both hands will be used actively.
Then, the pituitary, thyroid, parathyroid and adrenal glands and solar plexus points will be
stimulated for 5 minutes to assess fatigue. Each pressure was applied for about 5-10 seconds
and will be repeated 5-10 times. In the final stage, stretching the Achilles tendon, applying
pressure to the solar plexus and effleurage movements will be applied for five minutes. While
taking a deep breath, the patient's solar plexus will be pressed lightly, he will be asked to
hold his breath during the pressure, and the process will be terminated by reducing the
pressure applied to the point while exhaling. Then the same steps will be applied for the
left foot. Thus, reflexology will be applied to both feet for a total of 30 minutes (15
minutes on each foot). After the procedure is completed, the patient will be allowed to rest
for 5-10 minutes. During the application, the environment will be arranged as quiet and calm
as possible so that the researcher and the patient can concentrate.
3.5 Ethical considerations Clinical Research Ethics Committee approval (2019/459/(Ver:2)) was
obtained before starting the study.
