The Effect of Reiki on Fatigue and Comfort

NCT04830657 | Completed DMC

• 1 other identifier: Mersin Univer
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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. The hypothesis of the study is that distant reiki increases patients comfort and reduces fatigue.

Conditions

Hemodialysis; Fatigue

Keywords

Hemodialysis; Reiki; Fatigue; General Comfort; Nursing

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from before implementation, 4th week and 8th week of practice

Secondary Outcomes (1)

• Comfort evaluated using the General Comfort Scale

  Change from before implementation, 4th week and 8th week of practice

Study Arms (2)

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.

Other: Distant reiki

Control

OTHER

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

Other: Distant reiki

Interventions

Distant reiki 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; Distant reiki group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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,

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, Yenişehir, 33110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prelector- The Effect of Reiki on Fatigue and Comfort in Hemodialysis Patients

Model Details: Prospective, parallel, two arm, randomized controlled clinical trial, single masking

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 5, 2021
• Study Start: December 21, 2020
• Primary Completion: March 2, 2022
• Study Completion: March 2, 2022
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)