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

NCT06668623 | Recruiting DMC

• 2 other identifiers: 2024-SBB-078476397871
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Neuropathy

Keywords

Diabetic Neuropathy; Pain; Sleep Quality; Reiki

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale(VAS)

  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.

  Pre-test data will be collected before starting the study and post-test data will be collected 1 week later.

Secondary Outcomes (1)

• 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.

Other Outcomes (2)

• 4 Question Neuropathic Pain Questionnaire (DN4)

  Pre-test data will be collected before starting the study and post-test data will be collected 1 week later.

• Pittsburgh Uyku Kalitesi Endeksi PUKI

  Pre-test data will be collected before starting the study and post-test data will be collected 1 week later.

Study Arms (3)

Reiki Group

ACTIVE COMPARATOR

Remote Reiki application will be performed once a day for 20 minutes for four days by a researcher who has received second-level training.

Other: Reiki Group

Sham Reiki Group

SHAM COMPARATOR

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.

Other: Sham Reiki Group

control group

NO INTERVENTION

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

Interventions

Reiki Group 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.

Reiki Group

Sham Reiki Group 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.

Sham Reiki Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Question Neuropathic Pain score 4 and above
• Not having received Reiki treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Kayseri City Hospital

Kayseri, Kocasinan, 38010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies; Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Central Study Contacts

Fatma G. BURKEV, PhD student

CONTACT

+90 0352 315 77 00; fatmaburkev@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2024
• First Posted: October 31, 2024
• Study Start: November 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)