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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05892679
Other study ID # MersinUnv.VDG
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 30, 2023
Est. completion date September 30, 2023

Study information

Verified date June 2023
Source Mersin University
Contact VECIHE DÜZEL GÜNDÜZ
Phone +90 505 673 33 13
Email veciheduzel@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Turkey Turkey Mersin University Mersin

Sponsors (1)

Lead Sponsor Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from before implementation and 4th week of practice
Secondary 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. Change from before implementation and 4th week of practice
Secondary 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. Change from before implementation and 4th week of practice
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