Effect of Reiki on Neuropathic Pain Severity and Sleep Quality in Patients with Diabetic Neuropathy
- Conditions
- Diabetic Neuropathy
- Registration Number
- NCT06668623
- Lead Sponsor
- TC Erciyes University
- Brief Summary
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.
- Detailed Description
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.
H03: Second-level Reiki applied to patients with diabetic neuropathy for 20 minutes once a day for 4 days has no effect on sleep quality.
H13: Second-level Reiki applied to patients with diabetic neuropathy for 20 minutes once a day for 4 days has an effect on sleep quality.
Reiki/Sham Reiki Application Protocol After the assignment of patients with diabetic neuropathy to the groups by lot, the Reiki group will be applied remotely by a researcher who has received second-level training, and the Sham Reiki group will be applied remotely by a nurse who is not a Reiki practitioner trained by the researcher and has not received any training before, in accordance with the application protocol.
Research Groups Intervention Group-1 A 20-minute remote Reiki application will be applied once a day for four days by a researcher who has received second-level training. No changes will be made to the standard treatment plan of the patients during the application.
Intervention Group-2 A 20-minute remote Sham Reiki application will be applied once a day for four days by a nurse who has not received Reiki training and has not been initiated. No changes will be made to the standard treatment plan of the patients during the application.
Control Group No application will be applied to the patients for four weeks. Individuals will continue to receive their normal treatments.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Visual Analog Scale(VAS) 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.
- Secondary Outcome Measures
Name Time Method 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. The scale form provides information on the sensory intensity, size and perceived effects of pain. In this respect, the scale consists of three dimensions. The first dimension includes 15 items that define the quality of pain. 11 of the items are sensory and 4 determine the perceptual dimension of pain. The intensity of pain is indicated in the items by grading between 0-3 (0=none, 1=mild, 2=moderate, 3=excessive). In the first dimension, the perceptual pain score is evaluated between 0-12, the sensory pain score is evaluated between 0-33 and the total pain score is evaluated between 0-45. An increase in the total score indicates an increase in the pain level. In the second dimension, the intensity of pain felt by the individual is determined by five expressions ranging from "mild pain" to "unbearable pain". In the third dimension, the individual's instant intensity is compared visually.
The scale is listed in 0-5 points options. Minimum ''0=point, no pain; Indicates good condition.
Trial Locations
- Locations (1)
Kayseri City Hospital
🇹🇷Kayseri, Kocasinan, Turkey