The Effect of Acupressure in Hemodialysis Patients

NCT ID: NCT05892679

Last Updated: 2024-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-30

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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Fatigue Comfort Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized controlled study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Acupressure

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.

Group Type EXPERIMENTAL

acupressure

Intervention Type OTHER

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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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acupressure

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mersin University

OTHER

Sponsor Role lead

Responsible Party

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VECİHE DÜZEL GÜNDÜZ

MSN Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Turkey Mersin University

Mersin, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: INFORMED CONSENT FORM / WORKING GROUP

View Document

Document Type: Informed Consent Form: INFORMED CONSENT FORM / CONTROL GROUP

View Document

Other Identifiers

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MersinUnv.VDG

Identifier Type: -

Identifier Source: org_study_id

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