Effect of Reiki on Neuropathic Pain Severity and Sleep Quality in Patients with Diabetic Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual Analog Scale(VAS)
研究概览
简要总结
The study is planned to be conducted in a mixed research design with quantitative and qualitative types. The quantitative phase of the study was planned as a single-blind, randomized controlled study with Reiki group, Sham Reiki group and control group designs in order to examine the effect of second-level (remote application) Reiki applied to patients with diabetic neuropathy for 20 minutes a day for four days on pain intensity, neuropathic pain intensity (DN4 Questionnaire) total scores and sleep quality. The qualitative study will be conducted with 4 people from the Reiki and Sham Reiki groups, a total of 8 patients, one week after the application, using the individual in-depth interview method and a semi-structured questionnaire.
详细描述
Research hypotheses;
H01: Second-level Reiki applied to patients with diabetic neuropathy for 20 minutes once a day for 4 days has no effect on reducing pain intensity.
H11: Second-level Reiki applied to patients with diabetic neuropathy for 20 minutes once a day for 4 days has an effect on reducing pain intensity.
H02: Second-level Reiki applied to patients with diabetic neuropathy for 20 minutes once a day for 4 days has no effect on reducing neuropathic pain intensity.
H12: Second-level Reiki applied to patients with diabetic neuropathy for 20 minutes once a day for 4 days has an effect on reducing neuropathic pain intensity.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age
- •No communication problems
- •Communicating in Turkish
- •No diagnosis of mental illness
- •Willingness to participate in the study
- •Being competent enough to answer forms and surveys
- •VAS pain intensity 3 and above
- •4 Question Neuropathic Pain score 4 and above
- •Not having received Reiki treatment
排除标准
- •Receiving a different illness and treatment during the therapy process
- •Leaving Reiki practice
- •Psychiatric illness
- •Becoming a Reiki practitioner or instructor
- •Cerebrovascular disease
- •Receiving Reiki practice
研究组 & 干预措施
Reiki Group
Remote Reiki application will be performed once a day for 20 minutes for four days by a researcher who has received second-level training.
干预措施: Reiki Group (Other)
Sham Reiki Group
In the placebo group, the Sham Reiki group will receive remote Reiki application in accordance with the application protocol by a nurse who is not a Reiki practitioner trained by the researcher and has not received any previous training.
干预措施: Sham Reiki Group (Other)
control group
For four weeks, patients will not receive any treatment. Individuals will continue to receive their normal treatments.
结局指标
主要结局
Visual Analog Scale(VAS)
时间窗: Pre-test data will be collected before starting the study and post-test data will be collected 1 week later.
The value of "0 points" in the scale, which indicates the absence of pain, indicates a good condition, and the maximum value, "10 points", indicates a bad condition with unbearable pain intensity.
次要结局
- McGill Pain Scale - Short Form(Pre-test data will be collected before starting the study and post-test data will be collected 1 week later.)
研究者
Fatma Gonul Burkev
Principal Investigator
Kayseri City Hospital