- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05892679
The Effect of Acupressure in Hemodialysis Patients (acupress)
The Effect of Acupressure on Fatigue, Quality of Life and Comfort in Hemodialysis Patients. Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Mersin, Turkey
- Turkey Mersin University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
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: Control
No intervention will be made to the control group only the data will be collected at the same time as the study group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fatigue to be evaluated using the Piper Fatigue Scale
Time Frame: Change from before implementation and 4th week of practice
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Life Quality to be evaluated using Kidney Disease and Quality of Life Short Form (KDQOL-SF 1.3)
Time Frame: Change from before implementation and 4th week of practice
|
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
|
|
Comfort to be evaluated using Hemodialysis Comfort Scale
Time Frame: Change from before implementation and 4th week of practice
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MersinUnv.VDG
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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