Effectiveness of Massage Applied to Hemodialysis Patients

September 17, 2024 updated by: Zeynep Yildirim

Effect of Massage Applied to Hemodialysis Patients on Comfort Level and Fatigue

This study was conducted to determine the effect of massage on comfort and fatigue levels of hemodialysis patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Chronic renal failure (CRF) is a health problem that causes significant mortality and morbidity worldwide. The prevalence of the disease is increasing worldwide, especially in developing countries. Hemodialysis (HD) is the most common treatment method for CRF in the world. Approximately 90% of patients with CRF receive HD treatment. Despite advances in technology and medical care due to HD treatment, patients experience many physical and psychosocial symptoms. It is emphasized that comfort is significantly negatively affected in HD patients due to reasons such as the direct impact of HD treatment on the daily and social lives of patients. Increasing the comfort level is important for the patient to continue their daily life activities. In addition, comfort is accepted as the basis of quality nursing care. Increasing the comfort levels of HD patients provides lower comorbidity and mortality rates and improvement in institutional patient outcomes. Fatigue, one of the physical symptoms seen in HD patients, affects 60-95% of patients. Fatigue increases the patients' dependency levels, reduces their physical capabilities, negatively affects the patient and their family economically and reduces their quality of life. Therefore, effective management of fatigue is of great importance for the patient. Despite affecting the patients' lives to this extent, fatigue and discomfort have often been overlooked and neglected symptoms due to their subjective nature. Various pharmacological and non-pharmacological treatment methods are used to control fatigue due to CRF or HD and to bring the desired patient comfort. One of the non-pharmacological methods is massage. Massage can be defined as scientific systematic manipulations applied to body tissues in order to affect the locomotor system and nervous system as well as the general circulation. There are studies in the literature where various applications are applied to HD patients to affect fatigue and comfort. However, it is striking that there is no study examining the effect of massage on the comfort and fatigue levels of patients receiving HD treatment. Therefore, the research was planned to examine the effect of massage on the comfort level and fatigue level of HD patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Volunteering to participate in the study
  • Being 18 years of age or older
  • Receiving hemodialysis treatment in a dialysis unit for at least six months
  • Not having a condition that prevents verbal communication
  • Not having a psychiatric problem

Exclusion Criteria:

  • Patients who left the study at any stage
  • Patients who had been receiving hemodialysis treatment for less than 6 months

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Massage Group
Patients in the intervention group will receive post-hemodialysis massage twice a week for four weeks.
Other: Massage
After the hemodialysis, the patients will receive a 15-20 minute hand and foot massage. This application will be applied to the patients in two weekly dialysis sessions for a total of 8 sessions for four weeks. Before starting the massage applications, the patient's hands and feet will be washed and dried thoroughly. The patients will be given a semi-sitting or lying position that they can feel comfortable in. Before starting the hand and foot massage, the researcher will gently rub and warm their hands and wrists. The massages will start with a hand massage. A foot massage will be performed after the hand massage. 3-5 drops of baby oil applied at room temperature will be used to reduce friction during the massage. Effleurage, petrissage and friction styles of the massage will be applied.
No Intervention: Control Group
Routine nursing care was given to the patients in this group without any message.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hemodialysis Comfort Scale
Time Frame: Up to 4 weeks
The scale developed by Sahin Orak and his colleagues in 2017 consists of nine items and two sub-dimensions. These sub-dimensions are; "Relaxation" (7-9) and "Overcoming" (1- 6). The scale is a five-point Likert type (1: never -5: always). Items 1-3 and 5-9 of the scale are reverse coded. The lowest score that can be obtained from the scale is 9, the highest score is 45. The higher the score, the higher the comfort level.
Up to 4 weeks
Piper Fatigue Scale
Time Frame: Up to 4 weeks
The scale was developed by Barbara F. Piper and her friends in 1987 and adapted to Turkish by Can and her friends in 2001. The scale consists of 22 items and four sub-dimensions. These are; "Behavior/Violence" (2-7); "Affect" (8-12), "Sensory" (5 items; 13-17) and "Cognitive/Psychological" (18-23). In addition to this, there are five items (1 and 24-27) that are not used in calculating the fatigue score, but are recommended to remain in the scale because they are important in evaluating data related to fatigue. The scale is evaluated using a 0-10 Vizuel Analog Scale. The total score obtained from the scale is divided by the number of items. The minimum score that can be obtained from the scale is 0, and the maximum score is 10. The higher the score, the more fatigue the individual feels.
Up to 4 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zeynep Yildirim

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Massage

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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