THE EFFECT OF HAND AND FOOT MASSAGE ON FATIGUE IN HEMODIALYSIS PATIENTS

October 24, 2019 updated by: Sultan ÇEÇEN, Mersin University

Randomized Controlled Quasi-experimental

Hemodialysis patients face many problems related to disease and treatment, fatigue is stated as the most common of these problems. Therefore, The aim of this study is to examine the effect of hand massage and foot massage on fatigue in hemodialysis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In parallel with the recent technological advances in medicine, increasing the possibilities of diagnosis and treatment of diseases has increased the average life expectancy and the incidence of chronic diseases. Chronic renal failure (CRF), which is one of the increasing chronic diseases, has become an important public health problem due to its negative impact on quality of life both in the world and in our country, high morbidity, mortality and treatment costs. According to the Joint Report of the Turkish Ministry of Health and Turkish Nephrology Association; by the end of 2016, Renal Replacement Therapy (RRT) applied total 74,475 patients (including pediatric patients), RRT is applied and while the most common form of treatment has been found to be hemodialysis treatment with 76.12%. Unless a successful renal transplantation is performed, hemodialysis treatment required to be performed until the end of life and provides a longer life, but it also causes biological, psychological, social and economical problems arising from treatment. Fatigue, which often related to problems with its biological dimension, reduces the quality of life by adversely negatively affecting individual's daily life activities.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Batman, Turkey, 72000
        • Batman Regional State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • - Taking HD therapy, in the dialysis unit of a public hospital in Turkey, between October 19, 2018 - February 11, 2019,
  • Agree to participate in the study with a written permission,
  • Over the age of 18,
  • Open to communication with complete orientation,
  • Speaks and understands Turkish
  • Receiving HD treatment 3 times a week for 6 months and longer,
  • No loss of sensation, mass, fracture or ingrown toenail (onyxis),
  • In the lower extremities; without pathological and tumoral disease, phlesis, embolism and no bleeding disorder related to amputation, fracture, infection, wound, skin disease, muscle and bones,
  • Patients with a Standardized Mini Mental Test (SMMT) score of 24 or more, in patients older than 65 years,

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hand massage group
In the hand massage group (n = 28), hand massage was applied to the hand without fistula for 8 minutes, 3 times a week, for 4 weeks.
Other: hand massage
In the hand massage group (n = 28), hand massage was applied to the hand without fistula for 8 minutes, 3 times a week, for 4 weeks.
Experimental: Foot massages group
Foot massages were applied to both feet of the patients in the foot massage group (n = 28), 3 times a week, for 4 weeks and patting and kneading movements were repeated 3-4 times.
Other: foot massage
Foot massages were applied to both feet of the patients in the foot massage group (n = 28), 3 times a week, for 4 weeks and patting and kneading movements were repeated 3-4 times.
No Intervention: control group
The patients in the control group (n = 28) were not administered except nursing interventions in the HD unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-Hemodialysis / 1st Measurement
Time Frame: first day
In addition to verbal and written information, the first measurements were obtained by applying the Patient Presentation Form, Visual Similarity Scale for Fatigue to the patients who were taken to hand massage, foot massage and control groups before HD treatment. In 1990, Lee et al. developed the Visual Similarity Scale for Fatigue, consisting of 18 items, to determine fatigue. The items 1, 2, 3, 4, 5, 11, 12, 13, 14, 15, 16, 17, 18 of the scale included fatigue subcomponent and 6, 7, 8, 9,10 items belong to the energy subcomponent. The Visual Similarity Scale for Fatigue consists of 10 cm lines, the most positive expression at one end and the negative expression at the other end of the line. The high score of the fatigue subcomponent, the low score of the energy subcomponent, shows that the severity of fatigue is high.
first day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2 Weeks Later /2nd Measurement
Time Frame: fifteenth day
At the end of the second week of the hand massage and foot massage applications, the second measurements were obtained by reapplying the Visual Similarity Scale for Fatigue scale to all three groups.In 1990, Lee et al. developed the Visual Similarity Scale for Fatigue, consisting of 18 items, to determine fatigue. The items 1, 2, 3, 4, 5, 11, 12, 13, 14, 15, 16, 17, 18 of the scale included fatigue subcomponent and 6, 7, 8, 9,10 items belong to the energy subcomponent. The Visual Similarity Scale for Fatigue consists of 10 cm lines, the most positive expression at one end and the negative expression at the other end of the line. The high score of the fatigue subcomponent, the low score of the energy subcomponent, shows that the severity of fatigue is high.
fifteenth day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
4 Weeks Later/ 3rd Measurement
Time Frame: thirtieth day
At the end of the third week of the hand massage and foot massage applications, the third measurements were obtained by reapplying the Visual Similarity Scale for Fatigue scale to all three groups.In 1990, Lee et al. developed the Visual Similarity Scale for Fatigue, consisting of 18 items, to determine fatigue. The items 1, 2, 3, 4, 5, 11, 12, 13, 14, 15, 16, 17, 18 of the scale included fatigue subcomponent and 6, 7, 8, 9,10 items belong to the energy subcomponent. The Visual Similarity Scale for Fatigue consists of 10 cm lines, the most positive expression at one end and the negative expression at the other end of the line. The high score of the fatigue subcomponent, the low score of the energy subcomponent, shows that the severity of fatigue is high.
thirtieth day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mersin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2018

Primary Completion (Actual)

November 20, 2018

Study Completion (Actual)

February 11, 2019

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

October 23, 2019

First Posted (Actual)

October 25, 2019

Study Record Updates

Last Update Posted (Actual)

October 28, 2019

Last Update Submitted That Met QC Criteria

October 24, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Massage

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

de-identified individual participate data for all primary and secondary outcome measures will be made available

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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