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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTC Erciyes University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Over 18 years of age

No communication problems

Communicating in Turkish

No diagnosis of mental illness

Disqualifiers

Receiving a different illness and treatment during the therapy process

Leaving Reiki practice

Psychiatric illness

Becoming a Reiki practitioner or instructor

Trial design

Design model

Parallel

Treatments tested in this trial

  • Reiki Group

    Other intervention

    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

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Reiki GroupActive comparator 1 intervention
Group B: Sham Reiki GroupSham comparator 1 intervention
Group C: control groupNo intervention 0 interventions

Trial outcomes

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.

Time frame
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

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.

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

Other outcomes

1

4 Question Neuropathic Pain Questionnaire (DN4)

The first two questions are based on interviews with the patient; The first question is about the definition of pain (tingling, burning, cold), and the second question is; It is related to paresthesia and dysesthesia (numbness, prickling, tingling and itching) in the painful area. The third question examines sensory disturbances (needling, touch and hypoesthesia) in the area where the pain is localized, and the fourth question; It determines whether friction causes an increase in the presence and severity of pain. Each question is scored as "yes answer = 1 point" or "no answer = 0 point". A minimum score of 4 points and above indicates neuropathic pain. Indicates a bad situation. A maximum score of 10 is taken from the scale. This indicates that the pain is severe and worse.

Time frame
Pre-test data will be collected before starting the study and post-test data will be collected 1 week later.
2

Pittsburgh Uyku Kalitesi Endeksi PUKI

Each item is evaluated between 0-3 points. The scale consists of 7 subcomponents that evaluate objective sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), sleep habits, sleep disorders, sleeping pill use (component 5, component 6) and loss of daytime functionality. The sum of these components is the PSQI score. It indicates that sleep disturbance is severe in at least two of the 7 components or moderate in three component areas. A minimum score of 0-5 on the scale indicates that sleep quality is good. 5 points and above indicate that sleep quality is poor. Maximum scale total score It is 21 points.

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

Sponsors and contacts

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TC Erciyes University

Lead sponsor

Kayseri City Hospital

Sponsor institution