Effect of Reiki on Neuropathic Pain Severity and Sleep Quality in Patients With Diabetic Neuropathy

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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. No changes will be made to the standard treatment plan of the patients during the application.
• Другое 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.

Первичные конечные точки

• Visual Analog Scale(VAS) [Срок оценки: Pre-test data will be collected before starting the study and post-test data will be collected 1 week later.]

Вторичные конечные точки (1)

• McGill Pain Scale - Short Form [Срок оценки: Pre-test data will be collected before starting the study and post-test data will be collected 1 week later.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Kayseri City Hospital — Kayseri

Идентификаторы

NCT: NCT06668623 · 2024-SBB-0784 · 76397871

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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