The Effect of Reiki on Fatigue and Comfort in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Fatigue evaluated using the Fatigue Intensity Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •- 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.
结局指标
主要结局
Fatigue evaluated using the Fatigue Intensity Index
时间窗: 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.
次要结局
- Comfort evaluated using the General Comfort Scale(Change from before implementation, 4th week and 8th week of practice)
研究者
Melek Yesil Bayulgen
Prelector- The Effect of Reiki on Fatigue and Comfort in Hemodialysis Patients
Mersin University