The Effect of Reiki on Fatigue and Comfort

NCT ID: NCT04830657

Last Updated: 2022-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-21

Study Completion Date

2022-03-02

Brief Summary

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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

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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

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Hemodialysis Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, parallel, two arm, randomized controlled clinical trial, single masking
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Two groups (n = 31) will be determined by randomization created in computer environment by an independent researcher who is not involved in the study, and patients will be assigned to groups A or B created in computer environment. In determining the groups, lots were made with coins and group A was determined as the control group and group B as the remote reiki group. The information showing that the patients included in the study sample were assigned to the A and B groups according to the randomization table was put in an opaque envelope. This envelope will be kept by the coordinator researcher (MG) and when the researcher (MYB), who has a certificate of reiki application, goes to the patient for the application, he will fill in the "Informed Consent Form" and open the envelope to find out which group the patient is in. If the reiki group far from weakness comes out, the questionnaires will be filled out after verbal consent is obtained from the patient.

Study Groups

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Distant reiki group

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.

Group Type EXPERIMENTAL

Distant reiki

Intervention Type OTHER

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.

Control

Patients will receive routine treatment in accordance with the institution policy without any intervention in the control group.

Group Type OTHER

Distant reiki

Intervention Type OTHER

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.

Interventions

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Distant reiki

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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,
* 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.

Exclusion Criteria

* \- 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,
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mersin University

OTHER

Sponsor Role lead

Responsible Party

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Melek Yesil Bayulgen

Prelector- The Effect of Reiki on Fatigue and Comfort in Hemodialysis Patients

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mersin University

Mersin, Yenişehir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Mersin Univer

Identifier Type: -

Identifier Source: org_study_id

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