Clinical trial NCT04830657: The Effect of Reiki on Fatigue and Comfort
Official title: The Effect of Reiki on Fatigue and Comfort in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Fatigue
Keywords: Hemodialysis
Reiki
Fatigue
General Comfort
Nursing
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel, two arm, randomized controlled clinical trial, single masking
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fatigue evaluated using the Fatigue Intensity Index
timeFrame: Change from before implementation, 4th week and 8th week of practice
Secondary outcomes:
measure: Comfort evaluated using the General Comfort Scale
timeFrame: Change from before implementation, 4th week and 8th week of practice
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University
state: Yenişehir
Study officials:
References: