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CompletedNCT05833750Updated Apr 27, 2023

Effects of Reflexology in Transplant Patients

An interventional study of Reflexology in Renal Transplantation, Reflexology and Fatigue, sponsored by Sanko University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-27.

Sponsored by Sanko University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Dec 2020, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

  1. 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.

02

Conditions studied

  • Renal Transplantation
  • Reflexology
  • Fatigue
  • Nursing

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03

In context

Fatigue

1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.

This study's enrollment of 68 is above the median of 54 across 1,440 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

Sanko University is the lead sponsor of 49 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients, who were voluntary to participate in the study, aged between 18-75 years,
  • underwent renal transplantation,
  • had a PFS score of 1 or higher,
  • had no communication problem
  • underwent renal transplantation and
  • were discharged from the hospital for at least three months,
  • were residing in the -province, where the study was conducted, were included in the study.

Exclusion criteria

Exclusion Criteria:

  • who got 0 point on PFS, had open foot wounds,
  • suspected fractures,
  • burns and thrombocytopenia, were diagnosed with deep vein thrombosis and peripheral --neuropathy by the physician
  • were not voluntary to participate in the study, were excluded from the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
68 participants (actual)

Study arms

  • Active comparator
    reflexology

    Patients in the reflexology group were applied twice a week for eight weeks.

    Other: Reflexology

  • No intervention
    Control group

    No intervention was made

Interventions

  • OtherReflexology

    In the intervention group, reflexology was applied to the feet twice a week for 8 weeks.

06

What researchers measure

Primary outcomes

  1. Fatigue

    Piper Fatigue Scale: Fatigue Scale VAS is between 0-10 points and consists of 22 items. It has four sub-dimensions. Total fatigue score is obtained by summing the items and dividing them by the total number of items. Score increase; indicates an increased level of fatigue

    Time frame: 8 weeks

07

Study locations

1 site
  • Sanko university
    Gaziantep, Şehitkamil 27500, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05833750
Lead sponsor
Sanko University
Responsible party
hatıceguzel (directör, Sanko University) — Principal investigator
First posted
Apr 27, 2023
Start date
Dec 1, 2020
Primary completion
Feb 1, 2021
Completion
Jun 18, 2021
Last update
Apr 27, 2023

Study contacts

Hatice GUZEL
study director · Sanko University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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