Clinical trial NCT06668623: Effect of Reiki on Neuropathic Pain Severity and Sleep Quality in Patients With Diabetic Neuropathy
Official title: Effect of Reiki on Neuropathic Pain Severity and Sleep Quality in Patients With Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Neuropathy
Keywords: Diabetic Neuropathy
Pain
Sleep Quality
Reiki
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Visual Analog Scale(VAS)
timeFrame: Pre-test data will be collected before starting the study and post-test data will be collected 1 week later.
Secondary outcomes:
measure: McGill Pain Scale - Short Form
timeFrame: Pre-test data will be collected before starting the study and post-test data will be collected 1 week later.
Other outcomes:
measure: 4 Question Neuropathic Pain Questionnaire (DN4)
timeFrame: Pre-test data will be collected before starting the study and post-test data will be collected 1 week later.
measure: Pittsburgh Uyku Kalitesi Endeksi PUKI
timeFrame: Pre-test data will be collected before starting the study and post-test data will be collected 1 week later.
Locations:
city: Kayseri
country: Turkey
facility: Kayseri City Hospital
state: Kocasinan
Study officials:
References: