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The Effect of Acupressure in Hemodialysis Patients (acupress)

Primary Purpose

Fatigue, Comfort, Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
acupressure
Sponsored by
Mersin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fatigue focused on measuring acupressure, hemodialysis patients, Fatigue, Comfort, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written and verbal consent was obtained to participate in the study, Can read, write, speak and understand Turkish, Are older than 18 years, Have received HD treatment for at least 6 months, Receiving HD treatment 3 times a week, Fatigue severity ≥4, using a single-item fatigue index ranging from 0 to 10 points, Absence of lower extremity wounds Any complementary therapy Conscious, fully oriented and cooperative and open to communication, No visual, hearing and perception problems, Any psychiatric patient Exclusion Criteria: Wound or amputation of lower extremities, rheumatoid arthritis or limb fracture Any psychiatric disease, Patients with hepatitis B and hepatitis C, Using any of the complementary and integrated methods Those who receive HD treatment twice a week

Sites / Locations

  • Turkey Mersin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupressure

Control

Arm Description

Acupressure will be formulated according to the standards of the World Health Organization and applied to the determined points in a certain order. Since the reactions of individuals will be different from each other, the stiffness and pressure will be adjusted according to the sensitivity of the individual in order not to cause tissue damage. Pressures will be applied manually by a single practitioner. A total of 8 points with parallel points will be studied, with four points in each lower extremity. There will be a total of 12 minutes of pressure on 8 points, with an average of 90 seconds on each point, and approximately 10-15 seconds of warming and preparatory scrubbing before pressing on the area where the points are located. Considering the studies done, a person will be given acupressure three times a week for four weeks.

No intervention will be made to the control group only the data will be collected at the same time as the study group.

Outcomes

Primary Outcome Measures

Fatigue to be evaluated using the Piper Fatigue Scale
The total score obtained from the scale varies between 0 and 10 and as the score increases, the fatigue experienced by the individuals increases.

Secondary Outcome Measures

Life Quality to be evaluated using Kidney Disease and Quality of Life Short Form (KDQOL-SF 1.3)
Scores on each dimension range from 0 to 100, with higher scores reflecting better health related quality of life.
Comfort to be evaluated using Hemodialysis Comfort Scale
The score that can be obtained from the scale varies between 9 and 45. There is an inverse item in the scale.

Full Information

First Posted
May 27, 2023
Last Updated
June 12, 2023
Sponsor
Mersin University
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1. Study Identification

Unique Protocol Identification Number
NCT05892679
Brief Title
The Effect of Acupressure in Hemodialysis Patients
Acronym
acupress
Official Title
The Effect of Acupressure on Fatigue, Quality of Life and Comfort in Hemodialysis Patients. Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mersin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized controlled study evaluates the effect of acupressure application on fatigue, quality of life and comfort in hemodialysis patients. In our research, it is aimed to reduce fatigue, increase the quality of life and comfort level in hemodialysis patients with acupressure applied.
Detailed Description
In the study, 60 hemodialysis patients were randomly assigned to the study and control groups. The study group (n=30) Acupressure is formulated according to the standards of the World Health Organization and in a certain order to the points of Stomach 36 (St 36), Gall Bladder 34 point (GB 34), Spleen 6 point (SP 6) and Kidney 1 point (K 1) will be applied. Consideration will be given to the appropriate pressure intensity and duration. Since the reactions of individuals will be different from each other, the stiffness and pressure will be adjusted according to the sensitivity of the individual in order not to cause tissue damage. Pressures will be applied manually by a single practitioner. Considering the anatomical area where the point is located, the most suitable thumb, index and/or middle finger will be used for application to the relevant point. Successive compressions will be applied at a frequency that does not disturb the patient, does not cause pain, and has a calming effect. Considering the studies done, a person will be given acupressure three times a week for four weeks. No intervention will be made to the control group (n=30). In order to avoid ethical problems both groups will be given an informative training on acupressure and fatigue, increase the quality of life and comfort level in hemodialysis patients at the end of the study. The primary outcome of the study is the effect of acupuncture on fatigue in hemodialysis patients. The secondary result of the study is the effect of acupuncture on quality of life and comfort level in hemodialysis patients. The results will be collected before the acupressure and in the 4th week of the last intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Comfort, Quality of Life
Keywords
acupressure, hemodialysis patients, Fatigue, Comfort, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized controlled study
Masking
ParticipantOutcomes Assessor
Masking Description
The researcher cannot be blinded due to the nature of the research. However, participants will be blinded without knowing whether they are in the study group or the placebo group. Thus, the research will be carried out as a single-blind randomized controlled trial. When the research is completed, the data of the study and control groups (coded as A or B) will be transferred to the computer environment by an independent researcher, and the data will be analyzed by a statistician and the findings will be reported.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupressure
Arm Type
Experimental
Arm Description
Acupressure will be formulated according to the standards of the World Health Organization and applied to the determined points in a certain order. Since the reactions of individuals will be different from each other, the stiffness and pressure will be adjusted according to the sensitivity of the individual in order not to cause tissue damage. Pressures will be applied manually by a single practitioner. A total of 8 points with parallel points will be studied, with four points in each lower extremity. There will be a total of 12 minutes of pressure on 8 points, with an average of 90 seconds on each point, and approximately 10-15 seconds of warming and preparatory scrubbing before pressing on the area where the points are located. Considering the studies done, a person will be given acupressure three times a week for four weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention will be made to the control group only the data will be collected at the same time as the study group.
Intervention Type
Other
Intervention Name(s)
acupressure
Intervention Description
Acupressure will be formulated according to the standards of the World Health Organization and applied to the determined points in a certain order. Since the reactions of individuals will be different from each other, the stiffness and pressure will be adjusted according to the sensitivity of the individual in order not to cause tissue damage. Pressures will be applied manually by a single practitioner. A total of 8 points with parallel points will be studied, with four points in each lower extremity. There will be a total of 12 minutes of pressure on 8 points, with an average of 90 seconds on each point, and approximately 10-15 seconds of warming and preparatory scrubbing before pressing on the area where the points are located. Considering the studies done, a person will be given acupressure three times a week for four weeks.
Primary Outcome Measure Information:
Title
Fatigue to be evaluated using the Piper Fatigue Scale
Description
The total score obtained from the scale varies between 0 and 10 and as the score increases, the fatigue experienced by the individuals increases.
Time Frame
Change from before implementation and 4th week of practice
Secondary Outcome Measure Information:
Title
Life Quality to be evaluated using Kidney Disease and Quality of Life Short Form (KDQOL-SF 1.3)
Description
Scores on each dimension range from 0 to 100, with higher scores reflecting better health related quality of life.
Time Frame
Change from before implementation and 4th week of practice
Title
Comfort to be evaluated using Hemodialysis Comfort Scale
Description
The score that can be obtained from the scale varies between 9 and 45. There is an inverse item in the scale.
Time Frame
Change from before implementation and 4th week of practice

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written and verbal consent was obtained to participate in the study, Can read, write, speak and understand Turkish, Are older than 18 years, Have received HD treatment for at least 6 months, Receiving HD treatment 3 times a week, Fatigue severity ≥4, using a single-item fatigue index ranging from 0 to 10 points, Absence of lower extremity wounds Any complementary therapy Conscious, fully oriented and cooperative and open to communication, No visual, hearing and perception problems, Any psychiatric patient Exclusion Criteria: Wound or amputation of lower extremities, rheumatoid arthritis or limb fracture Any psychiatric disease, Patients with hepatitis B and hepatitis C, Using any of the complementary and integrated methods Those who receive HD treatment twice a week
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
VECİHE DÜZEL GÜNDÜZ
Phone
+90 505 673 33 13
Email
veciheduzel@gmail.com
Facility Information:
Facility Name
Turkey Mersin University
City
Mersin
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vecihe DÜZEL GÜNDÜZ, Master
Phone
+90 505 673 33 13
Email
2004160181004@mersin.edu.tr
Phone
+90 505 580 38 47
Email
didemlafci@hotmail.com
First Name & Middle Initial & Last Name & Degree
DİĞDEM LAFCI, Associate Professor

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be used outside of this research.

Learn more about this trial

The Effect of Acupressure in Hemodialysis Patients

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