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

NCT ID: NCT06668623

Last Updated: 2025-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-12-30

Brief Summary

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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

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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.

Conditions

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Diabetic Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Reiki Group

Intervention Type OTHER

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.

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.

Group Type SHAM_COMPARATOR

Sham Reiki Group

Intervention Type OTHER

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.

control group

For four weeks, patients will not receive any treatment. Individuals will continue to receive their normal treatments.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Gonul Burkev

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kayseri City Hospital

Kayseri, Kocasinan, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Fatma G. BURKEV, PhD student

Role: CONTACT

+90 0352 315 77 00

Facility Contacts

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Fatma Gönül BURKEV

Role: primary

05071549118

Other Identifiers

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76397871

Identifier Type: OTHER

Identifier Source: secondary_id

2024-SBB-0784

Identifier Type: -

Identifier Source: org_study_id

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