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An Alternative Approach to Fatigue and Comfort Levels in Hemodialysis Patients: Reiki Energy Therapy.

Primary Purpose

Hemodialysis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Reiki Energy Therapy
Sponsored by
Namik Kemal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemodialysis focused on measuring Chronic Renal Failure, Hemodialysis, Reiki, Therapy, Tiredness, Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Who is 18 years of age or older Who has been receiving hemodialysis treatment for at least 6 months and receives 3.hemodialysis for at least 2 sessions per week 4.Without communication and mental problems 5.Who can speak Turkish 6.Who agrees to participate in the study Exclusion Criteria: Who is under the age of 18 Who has been receiving hemodialysis for less than 6 months With communication and mental problems Who cannot speak Turkish Those who do not agree to participate in the study

Sites / Locations

  • Nurhan ÖZPANCAR ŞOLPANRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

enterprise group

Control group

Arm Description

Reiki therapy will be applied to the initiative group. Evaluation will be carried out with pre-test and post-test

The control group will not be interfered with. The control group will not be interfered with and will only be evaluated by pre-test and post-test by monitoring.

Outcomes

Primary Outcome Measures

Reiki Energy Therapy
The scales to be used are the Fatigue Severity Scale and Hemodialysis Comfort Scale II. With these scales Changes in fatigue and comfort levels will be expected in hemodialysis patients with reiki treatment. The Fatigue Severity Scale (YÖS): Krupp et al. it was developed by (1989) and the scale was developed by Armutlu et al. a Turkish validity and reliability study was conducted by Dec in 2003; Cronbach alpha value: 0.85 and consists of 9 items, each item is scored between 1-7 (1=I disagree at all, 7=I completely agree) and the total score is calculated by taking the average of 9 items. The average was determined as "<2.8; No fatigue, >6.1 ; I have Chronic Fatigue Syndrome". The lower the total score, the less fatigue.

Secondary Outcome Measures

Hemodialysis Comfort Scale II (HKÖ)
Hemodialysis Comfort Scale II (HKÖ): This scale, developed by Coşar by conducting a literature review, is a 5-point likert type scale consisting of 26 items - six sub-dimensions. Substances that are not reversed on the scale (19, 20, 22, 25, 26) 1 from towards 5; inverse substances (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 21, 23, 24) 5 it is scored from 1 to correct. Comfort increases as the scale score increases, comfort decreases as the score decreases. The items and December of points included in the sub-dimensions; Physical refreshment: 5, 6, 7, 8. (4-20 points) Physical relaxation: 1, 2, 3, 4. (4-20 points) Psychospirital relaxation: 18, 19, 20, 21, 22, 23, 24, 25, 26. (9-45 points) Psychospiritual empowerment: 14, 15, 16, 17. (4-20 points) Environmental empowerment: 12, 13. (2-10 points) Sociocultural relaxation: 9, 10, 11. (3-15 points) and the scale score December min - max= 26-130 points

Full Information

First Posted
September 1, 2023
Last Updated
October 3, 2023
Sponsor
Namik Kemal University
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1. Study Identification

Unique Protocol Identification Number
NCT06072846
Brief Title
An Alternative Approach to Fatigue and Comfort Levels in Hemodialysis Patients: Reiki Energy Therapy.
Official Title
An Alternative Approach to Fatigue and Comfort Levels in Hemodialysis Patients: Reiki Energy Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
September 4, 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Chronic renal failure (CRF) is a chronic and progressive kidney disease caused by impaired metabolic and endocrine functions as a result of a decrease in glomerular filtration rate (GFR), the role of the kidney in maintaining fluid electrolyte balance. KRG, which has high mortality and morbidity, is defined as an important public health problem due to the fact that it also causes a great burden on health systems. Reiki is not an alternative to allopathic medicine; it is a "complementary" therapy that can be applied together with all other medical and therapeutic techniques. It has been reported that the deep relaxation created by Reiki relieves anxiety, stress and pain perception and promotes a feeling of psycho-spiritual well-being. Reiki strengthens the energy pathways and meridians, facilitates the natural process of healing. It regulates the energy systems of the body that are blocked by stress or a negative situation. Reiki, which is applied for various purposes, ensures that blood and lymph circulation continue in a healthy way, stimulates the autonomic nervous system. In this way, reiki facilitates physical and spiritual relaxation and strengthens health.
Detailed Description
Chronic renal failure (CRF) is a chronic and progressive kidney disease caused by impaired metabolic and endocrine functions as a result of a decrease in glomerular filtration rate (GFR), the role of the kidney in maintaining fluid electrolyte balance. KRG, which has high mortality and morbidity, is defined as an important public health problem due to the fact that it also causes a great burden on health systems.The development and stage of chronic kidney failure are related to the patient's symptoms and clinical signs. Patients are usually asymptomatic until stage 4-5. Symptoms of the disease generally begin with weakness. When the GFR falls below 30 ml/min, clinical signs are observed in the patient. No matter what stage of KRG is, dietary and pharmacological treatment methods are required. Renal replacement therapies are peritoneal dialysis, kidney transplantation and hemodialysis. Hemodialysis treatment is the process of cleaning the blood taken from the patient by passing it into dialysis fluid through a semi-permeable membrane with the help of a machine to eliminate waste products that cannot be removed from the blood, such as creatinine, urea, in patients with end-stage renal failure, and returning it to the patient. Difficulties and complications experienced in the adaptation process related to the disease and treatment in hemodialysis patients negatively affect patient comfort. Various methods have been used to reduce the symptoms experienced by hemodialysis patients and increase their comfort level. It has been found that complementary therapies such as aromatherapy, progressive relaxation exercises, music therapy, acupressure, massage therapy, reflexology, yoga and reiki, which hemodialysis patients use to relieve fatigue, have an effect on symptoms. Difficulties and complications experienced in the adaptation process related to the disease and treatment in hemodialysis patients negatively affect patient comfort. Various methods have been used to reduce the symptoms experienced by hemodialysis patients and increase their comfort level. It has been found that complementary therapies such as aromatherapy, progressive relaxation exercises, music therapy, acupressure, massage therapy, reflexology, yoga and reiki, which hemodialysis patients use to relieve fatigue, have an effect on symptoms. Reiki is not an alternative to allopathic medicine; it is a "complementary" therapy that can be applied together with all other medical and therapeutic techniques. It has been reported that the deep relaxation created by Reiki relieves anxiety, stress and pain perception and promotes a feeling of psycho-spiritual well-being.Reiki strengthens the energy pathways and meridians, facilitates the natural process of healing. It regulates the energy systems of the body that are blocked by stress or a negative situation. Reiki, which is applied for various purposes, ensures that blood and lymph circulation continue in a healthy way, stimulates the autonomic nervous system. In this way, reiki facilitates physical and spiritual relaxation and strengthens health.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis
Keywords
Chronic Renal Failure, Hemodialysis, Reiki, Therapy, Tiredness, Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There is an initiative and control group. Reiki therapy will be provided to the intervention group. Monitoring will be performed on the control group.
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
enterprise group
Arm Type
Experimental
Arm Description
Reiki therapy will be applied to the initiative group. Evaluation will be carried out with pre-test and post-test
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will not be interfered with. The control group will not be interfered with and will only be evaluated by pre-test and post-test by monitoring.
Intervention Type
Behavioral
Intervention Name(s)
Reiki Energy Therapy
Intervention Description
Reiki Therapy will be applied to the intervention group
Primary Outcome Measure Information:
Title
Reiki Energy Therapy
Description
The scales to be used are the Fatigue Severity Scale and Hemodialysis Comfort Scale II. With these scales Changes in fatigue and comfort levels will be expected in hemodialysis patients with reiki treatment. The Fatigue Severity Scale (YÖS): Krupp et al. it was developed by (1989) and the scale was developed by Armutlu et al. a Turkish validity and reliability study was conducted by Dec in 2003; Cronbach alpha value: 0.85 and consists of 9 items, each item is scored between 1-7 (1=I disagree at all, 7=I completely agree) and the total score is calculated by taking the average of 9 items. The average was determined as "<2.8; No fatigue, >6.1 ; I have Chronic Fatigue Syndrome". The lower the total score, the less fatigue.
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Hemodialysis Comfort Scale II (HKÖ)
Description
Hemodialysis Comfort Scale II (HKÖ): This scale, developed by Coşar by conducting a literature review, is a 5-point likert type scale consisting of 26 items - six sub-dimensions. Substances that are not reversed on the scale (19, 20, 22, 25, 26) 1 from towards 5; inverse substances (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 21, 23, 24) 5 it is scored from 1 to correct. Comfort increases as the scale score increases, comfort decreases as the score decreases. The items and December of points included in the sub-dimensions; Physical refreshment: 5, 6, 7, 8. (4-20 points) Physical relaxation: 1, 2, 3, 4. (4-20 points) Psychospirital relaxation: 18, 19, 20, 21, 22, 23, 24, 25, 26. (9-45 points) Psychospiritual empowerment: 14, 15, 16, 17. (4-20 points) Environmental empowerment: 12, 13. (2-10 points) Sociocultural relaxation: 9, 10, 11. (3-15 points) and the scale score December min - max= 26-130 points
Time Frame
1 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Who is 18 years of age or older Who has been receiving hemodialysis treatment for at least 6 months and receives 3.hemodialysis for at least 2 sessions per week 4.Without communication and mental problems 5.Who can speak Turkish 6.Who agrees to participate in the study Exclusion Criteria: Who is under the age of 18 Who has been receiving hemodialysis for less than 6 months With communication and mental problems Who cannot speak Turkish Those who do not agree to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nurhan ÖZPANCAR ŞOLPAN
Phone
+90 (282) 2503114
Email
nozpancar@nku.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nurhan ÖZPANCAR ŞOLPAN
Organizational Affiliation
Namik Kemal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nurhan ÖZPANCAR ŞOLPAN
City
Tekirdağ
ZIP/Postal Code
59030
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nurhan ÖZPANCAR ŞOLPAN
Phone
+90 (282) 2503114
Email
nozpancar@nku.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33550227
Citation
Yang F, Liao M, Wang P, Liu Y. Cost-effectiveness analysis of renal replacement therapy strategies in Guangzhou city, southern China. BMJ Open. 2021 Feb 5;11(2):e039653. doi: 10.1136/bmjopen-2020-039653.
Results Reference
background
PubMed Identifier
28874060
Citation
McManus DE. Reiki Is Better Than Placebo and Has Broad Potential as a Complementary Health Therapy. J Evid Based Complementary Altern Med. 2017 Oct;22(4):1051-1057. doi: 10.1177/2156587217728644. Epub 2017 Sep 5.
Results Reference
background
PubMed Identifier
18515247
Citation
Bossi LM, Ott MJ, DeCristofaro S. Reiki as a clinical intervention in oncology nursing practice. Clin J Oncol Nurs. 2008 Jun;12(3):489-94. doi: 10.1188/08.CJON.489-494.
Results Reference
background
Links:
URL
https://turkjnephrol.org/en/current-status-of-renal-replacement-therapies-in-turkey-summary-of-turkish-society-of-nephrology-registry-2016-report-1627021
Description
The Current Status of Renal Replacement Therapies in Turkey: Turkish Society of Nephrology Registration Summary 2016 Report
URL
https://bijps.uobaghdad.edu.iq/index.php/bijps/article/view/1235/927
Description
Comparing the Effects of Lavender Oil and Olive Oil Massage on Pain due to Muscular Cramp during Hemodialysis

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An Alternative Approach to Fatigue and Comfort Levels in Hemodialysis Patients: Reiki Energy Therapy.

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