HemodialysisNCT04830657
The Effect of Reiki on Fatigue and Comfort
A study testing Distant reiki in people with Hemodialysis and Fatigue, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
This study is a single blind, randomized parallel controlled experimental study planned to determine the effect of distant reiki, which is one of the non-pharmacological methods, on fatigue and comfort level in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemodialysis, Fatigue
- What is being tested?
- Distant reiki
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Dec 2020to 2 Mar 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over the age of 18
- In patients over the age of 65, the Standardized Mini Mental Test (SMMT) score is 26 and above,
- Having hemodialysis three days / times a week for 6 months or longer with the diagnosis of chronic renal failure,
- Can speak and understand Turkish,
- General condition is good and comfortable (whose life findings are within normal limits)
- Do not have any problem that prevents cognitive, affective and verbal communication,
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- Do not use any sedative drugs,
- Do not have any psychiatric illness,
- Those who sign the informed consent form will be included in the sample.
Who cannot join
- - who do not agree to participate in the study,
- younger than 18,
- In patients over 65 years of age, whose SMMT value is below 24 points
- Patients undergoing hemodialysis without a diagnosis of chronic renal failure,
- Receiving hemodialysis treatment for less than 6 months and once or twice a week,
- Can't speak Turkish,
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- General condition unstable (shortness of breath, arrhythmia, fluctuations in blood pressure),
- Diagnosed with anxiety, panic attack and using medication for anxiety,
- Using any sedative medication,
- Have any problem that prevents cognitive, affective and verbal communication,
- Any psychiatric illness,
- Those who do not sign the informed volunteer consent form will not be included in the study.
- Study termination criteria:
- Who want to leave the research,
- Changing institution / province,
- If the patient dies, the study will be terminated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Reiki on Fatigue and Comfort in Hemodialysis Patients
This study is a single blind, randomized parallel controlled experimental study planned to determine the effect of distant reiki, which is one of the non-pharmacological methods, on fatigue and comfort level in hemodialysis patients. The hypothesis of the study is that distant reiki increases patients comfort and reduces fatigue.
Read the detailed description
Methods: In order to determine the sample size of the study, before starting the research, power analysis was performed by taking the information of the statistician and previous studies as a reference in order to determine the number of patients to be included in the reiki and control groups. As a result of the analysis performed by taking effect size 0.35, type 1 error 0.05, power 0.80 and correlation between repeated measurements 0.50, it is planned to study with a total of 46 patients, including at least 31 patients in each group. The remote reiki group will be given remote reiki 3 times a week for 4 weeks by the researcher who has a reiki application certificate. Remote reiki sessions will be performed by the reiki practitioner the night before the hemodialysis day of the patient, and the session duration will take approximately 36-40 minutes. After the individuals receive 12 sessions of remote reiki (1 month later), the questionnaire will be filled in for the second measurement. In order to determine whether reiki has an effect in the long term, 4 weeks (1 month) after the second measurement, the questionnaire for the third measurement will be completed and the research will be completed. Patients will receive routine treatment in accordance with the institution policy without any intervention in the control group. The control group will be filled in the questionnaire after the first measurement, in the 4th (1st month) and 8th (2nd month) weeks. At the end of the study, remote reiki sessions will be applied by the researcher, since the patients in the control group have equal ethical rights. The primary expected result of the study is the effect of distant reiki on fatigue in hemodialysis patients. The second expected result of the study is to determine the effect of distant reiki on comfort.
- Conditions
- Hemodialysis, Fatigue
- Being tested
- Distant reiki
- Keywords
- Hemodialysis, Reiki, Fatigue, General Comfort, Nursing
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distant reikiOther
In order to determine the sample size of the study, it is planned to study with a total of 62 patients, including at least 31 patients in each group, in the power analysis based on the statistics of the statistician and previous studies. The remote reiki group will be given remote reiki 3 times a week for 4 weeks by the researcher who has a reiki application certificate. Remote reiki sessions will be performed by the reiki practitioner the night before the hemodialysis day of the patient, and the session duration will take approximately 36-40 minutes. After the individuals receive 12 sessions of remote reiki (1 month later), the questionnaire will be filled in for the second measurement. In order to determine whether reiki has an effect in the long term, 4 weeks (1 month) after the second measurement, the questionnaire for the third measurement will be completed and the research will be completed.
| Study group | Role | What they receive |
|---|---|---|
| Distant reiki group | Experimental | The application will be carried out by the researcher who has received level 2 reiki training. Reiki energy will be sent to the individuals who have undergone hemodialysis with the intention of healing. The Reiki practitioner is enabled to send the Reiki remotely in a quiet and lonely room. The practitioner moves to the right side of the individual, imagining as if he is next to the individual, and his aura (the energy that exists around the body) is corrected 3 times from above and from the head to the feet. The practitioner's hands are held side by side. Starting from the beginning of the application, reiki energy is sent to the 7 main chakras in an average of 3 minutes, from top to bottom. Each session is approximately 21-25 minutes. After the session, the chakra equalization process is applied to help the frequencies of the chakras to work in harmony with each other. 15 minutes in total. Balancing is done. Receives: Other: Distant reiki |
| Control | Other | Patients will receive routine treatment in accordance with the institution policy without any intervention in the control group. Receives: Other: Distant reiki |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue evaluated using the Fatigue Intensity Index
The Fatigue Severity Scale will be used to measure the severity of fatigue. The Turkish validity and reliability of the scale, which was developed by Krupp et al in 1989, was carried out in 2007 by Armutlu et al. Each item is scored between 1 and 7 (1 = strongly disagree, 7 = totally agree) in the scale consisting of 9 items that can be applied by individuals in a simple way. The total score range of the scale is 9-63. The total score is calculated by taking the average of 9 items. Accordingly, the lowest average score to be obtained is 1, and the highest average score is 7. The cut-off value was set at 4 and above to diagnose pathological fatigue. The lower the total score, the less fatigue.
Measured: Change from before implementation, 4th week and 8th week of practice
Secondary outcomes (1)
Comfort evaluated using the General Comfort Scale
The Turkish validity and reliability of the scale, which was developed by Kolcaba in 2006, was carried out by Kuğuoğlu and Karabacak in 2008. The scale is 4-point Likert type with 48 items. Comfort theory includes the sub-dimensions of relaxation (9 items), relaxation (9 items) and coping with problems (10 items). There are negative and positive items in the scale. Reverse coding process is applied for negative items, and the lowest total score obtained from the scale is 48 and the highest total score is 192. The mean score of the scale is calculated by dividing the total score obtained from the scale by the number of items. 1 point from the questionnaire indicates low comfort and 4 points indicate high comfort. While Cronbach's alpha reliability coefficient was 0.88 in the reliability study conducted by Kolcaba, it was calculated as 0.85 in the study of Kuğuoğlu and Karabacak who conducted the Turkish validity and reliability study.
Measured: Change from before implementation, 4th week and 8th week of practice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start21 Dec 2020
- Primary completion2 Mar 2022
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Prospective, parallel, two arm, randomized controlled clinical trial, single masking
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melek Yesil Bayulgen, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830657
- Sponsor's protocol ID
- Mersin Univer
- Status last verified
- Apr 2022
- First submitted
- 31 Mar 2021
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reiki on Fatigue and Comfort in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT04830657
- Acronym / sponsor ID
- Mersin Univer
- Conditions
- Hemodialysis, Fatigue
- Keywords
- Hemodialysis, Reiki, Fatigue, General Comfort, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 5 Apr 2021 (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.
This study is a single blind, randomized parallel controlled experimental study planned to determine the effect of distant reiki, which is one of the non-pharmacological methods, on fatigue and comfort level in hemodialysis patients. The hypothesis of the study is that distant reiki increases patients comfort and reduces fatigue.
Detailed description
Methods: In order to determine the sample size of the study, before starting the research, power analysis was performed by taking the information of the statistician and previous studies as a reference in order to determine the number of patients to be included in the reiki and control groups. As a result of the analysis performed by taking effect size 0.35, type 1 error 0.05, power 0.80 and correlation between repeated measurements 0.50, it is planned to study with a total of 46 patients, including at least 31 patients in each group. The remote reiki group will be given remote reiki 3 times a week for 4 weeks by the researcher who has a reiki application certificate. Remote reiki sessions will be performed by the reiki practitioner the night before the hemodialysis day of the patient, and the session duration will take approximately 36-40 minutes. After the individuals receive 12 sessions of remote reiki (1 month later), the questionnaire will be filled in for the second measurement. In order to determine whether reiki has an effect in the long term, 4 weeks (1 month) after the second measurement, the questionnaire for the third measurement will be completed and the research will be completed. Patients will receive routine treatment in accordance with the institution policy without any intervention in the control group. The control group will be filled in the questionnaire after the first measurement, in the 4th (1st month) and 8th (2nd month) weeks. At the end of the study, remote reiki sessions will be applied by the researcher, since the patients in the control group have equal ethical rights. The primary expected result of the study is the effect of distant reiki on fatigue in hemodialysis patients. The second expected result of the study is to determine the effect of distant reiki on comfort.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, parallel, two arm, randomized controlled clinical trial, single masking
| Arm | Type | Receives |
|---|---|---|
| Distant reiki group | Experimental | Other: Distant reikiThe application will be carried out by the researcher who has received level 2 reiki training. Reiki energy will be sent to the individuals who have undergone hemodialysis with the intention of healing. The Reiki practitioner is enabled to send the Reiki remotely in a quiet and lonely room. The practitioner moves to the right side of the individual, imagining as if he is next to the individual, and his aura (the energy that exists around the body) is corrected 3 times from above and from the head to the feet. The practitioner's hands are held side by side. Starting from the beginning of the application, reiki energy is sent to the 7 main chakras in an average of 3 minutes, from top to bottom. Each session is approximately 21-25 minutes. After the session, the chakra equalization process is applied to help the frequencies of the chakras to work in harmony with each other. 15 minutes in total. Balancing is done. |
| Control | Other | Other: Distant reikiPatients will receive routine treatment in accordance with the institution policy without any intervention in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Over the age of 18
- In patients over the age of 65, the Standardized Mini Mental Test (SMMT) score is 26 and above,
- Having hemodialysis three days / times a week for 6 months or longer with the diagnosis of chronic renal failure,
- Can speak and understand Turkish,
- General condition is good and comfortable (whose life findings are within normal limits)
Key exclusion criteria (16 listed)
- - who do not agree to participate in the study,
- younger than 18,
- In patients over 65 years of age, whose SMMT value is below 24 points
- Patients undergoing hemodialysis without a diagnosis of chronic renal failure,
- Receiving hemodialysis treatment for less than 6 months and once or twice a week,
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 |
|---|---|---|
| Distant reikiIn order to determine the sample size of the study, it is planned to study with a total of 62 patients, including at least 31 patients in each group, in the power analysis based on the statistics of the statistician and previous studies. The remote reiki group will be given remote reiki 3 times a week for 4 weeks by the researcher who has a reiki application certificate. Remote reiki sessions will be performed by the reiki practitioner the night before the hemodialysis day of the patient, and the session duration will take approximately 36-40 minutes. After the individuals receive 12 sessions of remote reiki (1 month later), the questionnaire will be filled in for the second measurement. In order to determine whether reiki has an effect in the long term, 4 weeks (1 month) after the second measurement, the questionnaire for the third measurement will be completed and the research will be completed. | Other | Control, Distant reiki group |
Primary outcome
Fatigue evaluated using the Fatigue Intensity Index
Time frame: Change from before implementation, 4th week and 8th week of practice
The Fatigue Severity Scale will be used to measure the severity of fatigue. The Turkish validity and reliability of the scale, which was developed by Krupp et al in 1989, was carried out in 2007 by Armutlu et al. Each item is scored between 1 and 7 (1 = strongly disagree, 7 = totally agree) in the scale consisting of 9 items that can be applied by individuals in a simple way. The total score range of the scale is 9-63. The total score is calculated by taking the average of 9 items. Accordingly, the lowest average score to be obtained is 1, and the highest average score is 7. The cut-off value was set at 4 and above to diagnose pathological fatigue. The lower the total score, the less fatigue.
1 secondary outcome
Comfort evaluated using the General Comfort Scale
Time frame: Change from before implementation, 4th week and 8th week of practice
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distant reiki in people with Hemodialysis and Fatigue, run by Mersin 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 9 inclusion and 16 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: finished, as of the sponsor's last update on 13 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue evaluated using the Fatigue Intensity Index (time frame: Change from before implementation, 4th week and 8th week of practice). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2022.