HemodialysisNCT06072846
An Alternative Approach to Fatigue and Comfort Levels in Hemodialysis Patients: Reiki Energy Therapy.
A study testing Reiki Energy Therapy in people with Hemodialysis, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Reiki Energy Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 4 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Nurhan ÖZPANCAR ŞOLPAN
Tekirdağ, 59030
Nurhan ÖZPANCAR ŞOLPAN, +90 (282) 2503114, nozpancar@nku.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemodialysis
- Being tested
- Reiki Energy Therapy
- Keywords
- Chronic Renal Failure, Hemodialysis, Reiki, Therapy, Tiredness, Disease
- Medical subject headings
- Kidney Failure, Chronic, Fatigue, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reiki Energy TherapyBehavioural
Reiki Therapy will be applied to the intervention group
| Study group | Role | What they receive |
|---|---|---|
| enterprise group | Experimental | Reiki therapy will be applied to the initiative group. Evaluation will be carried out with pre-test and post-test Receives: Behavioral: Reiki Energy Therapy |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 years
Secondary outcomes (1)
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
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion4 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Topac, Namik Kemal University
- Investigators
- Nurhan ÖZPANCAR ŞOLPAN, Principal investigator, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072846
- Sponsor's protocol ID
- NamikKU.
- Status last verified
- Oct 2023
- First submitted
- 1 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33550227McManus 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.
PubMed 28874060Bossi 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.
PubMed 18515247
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Alternative Approach to Fatigue and Comfort Levels in Hemodialysis Patients: Reiki Energy Therapy
- ClinicalTrials.gov ID
- NCT06072846
- Acronym / sponsor ID
- NamikKU.
- Conditions
- Hemodialysis
- Keywords
- Chronic Renal Failure, Hemodialysis, Reiki, Therapy, Tiredness, Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 4 Sep 2024 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| enterprise group | Experimental | Behavioral: Reiki Energy TherapyReiki therapy will be applied to the initiative group. Evaluation will be carried out with pre-test and post-test |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reiki Energy TherapyReiki Therapy will be applied to the intervention group | Behavioural | enterprise group |
Primary outcome
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 secondary outcome
Hemodialysis Comfort Scale II (HKÖ)
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Background: PubMed 33550227Yang 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.
- Background: PubMed 28874060McManus 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.
- Background: PubMed 18515247Bossi 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.
- The Current Status of Renal Replacement Therapies in Turkey: Turkish Society of Nephrology Registration Summary 2016 ReportLink provided by the sponsor.
- Comparing the Effects of Lavender Oil and Olive Oil Massage on Pain due to Muscular Cramp during HemodialysisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurhan ÖZPANCAR ŞOLPAN principal investigator
Namik Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reiki Energy Therapy in people with Hemodialysis, run by Namik Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nurhan ÖZPANCAR ŞOLPAN (+90 (282) 2503114, nozpancar@nku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reiki Energy Therapy (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06072846, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.