- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06072846
An Alternative Approach to Fatigue and Comfort Levels in Hemodialysis Patients: Reiki Energy Therapy.
An Alternative Approach to Fatigue and Comfort Levels in Hemodialysis Patients: Reiki Energy Therapy
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.
Study Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nurhan ÖZPANCAR ŞOLPAN
- Phone Number: +90 (282) 2503114
- Email: nozpancar@nku.edu.tr
Study Locations
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-
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Tekirdağ, Turkey, 59030
- Recruiting
- Nurhan ÖZPANCAR ŞOLPAN
-
Contact:
- Nurhan ÖZPANCAR ŞOLPAN
- Phone Number: +90 (282) 2503114
- Email: nozpancar@nku.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
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: enterprise group
Reiki therapy will be applied to the initiative group.
Evaluation will be carried out with pre-test and post-test
|
Reiki Therapy will be applied to the intervention group
|
|
No Intervention: Control group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reiki Energy Therapy
Time Frame: 1 years
|
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. |
1 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hemodialysis Comfort Scale II (HKÖ)
Time Frame: 1 years
|
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
|
1 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nurhan ÖZPANCAR ŞOLPAN, Namik Kemal University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NamikKU.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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