NCT05833750

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

March 27, 2023

Last Update Submit

April 25, 2023

Conditions

Outcome Measures

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

    8 weeks

Study Arms (2)

reflexology

ACTIVE COMPARATOR

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

Other: Reflexology

Control group

NO INTERVENTION

No intervention was made

Interventions

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

reflexology

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanko university

Gaziantep, Şehitkamil, 27500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Hatice GUZEL

    Sanko University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
participants'personal information is hidden
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
directör

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 27, 2023

Study Start

December 1, 2020

Primary Completion

February 1, 2021

Study Completion

June 18, 2021

Last Updated

April 27, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations