Effects of Reflexology in Transplant Patients
Condition: Renal Transplantation; Reflexology; Fatigue; Nursing
MeSH terms: Fatigue
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Reflexology
Intervention type(s): Other
Intervention description(s): In the intervention group, reflexology was applied to the feet twice a week for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment