Diabetic NeuropathyNCT06668623
Effect of Reiki on Neuropathic Pain Severity and Sleep Quality in Patients With Diabetic Neuropathy
A study testing Reiki Group in people with Diabetic Neuropathy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- Reiki Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- VAS pain intensity 3 and above
- 4 Question Neuropathic Pain score 4 and above
- Not having received Reiki treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kayseri City Hospital
Kayseri, Kocasinan, 38010
Fatma Gönül BURKEV, 05071549118
Fatma Gönül BURKEV, Phd.Student
About this study
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.
Read the 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.
- Conditions
- Diabetic Neuropathy
- Being tested
- Reiki Group, Sham Reiki Group
- Keywords
- Diabetic Neuropathy, Pain, Sleep Quality, Reiki
- Medical subject headings
- Diabetic Neuropathies, Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reiki GroupOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Pre-test data will be collected before starting the study and post-test data will be collected 1 week later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start1 Nov 2024
- Primary completion30 May 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Gonul Burkev, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668623
- Sponsor's protocol ID
- 2024-SBB-0784
- Other IDs
- 76397871
- Status last verified
- Feb 2025
- First submitted
- 26 Oct 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Once the study is completed, its results will be shared with other researchers once the study data is published.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Reiki on Neuropathic Pain Severity and Sleep Quality in Patients With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT06668623
- Acronym / sponsor ID
- 2024-SBB-0784
- Conditions
- Diabetic Neuropathy
- Keywords
- Diabetic Neuropathy, Pain, Sleep Quality, Reiki
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reiki Group | Active comparator | Other: Reiki GroupRemote Reiki application will be performed once a day for 20 minutes for four days by a researcher who has received second-level training. |
| Sham Reiki Group | Sham comparator | Other: Sham Reiki GroupIn 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 | No intervention | –For four weeks, patients will not receive any treatment. Individuals will continue to receive their normal treatments. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Over 18 years of age
- No communication problems
- Communicating in Turkish
- No diagnosis of mental illness
- Willingness to participate in the study
Key exclusion criteria (6 listed)
- Receiving a different illness and treatment during the therapy process
- Leaving Reiki practice
- Psychiatric illness
- Becoming a Reiki practitioner or instructor
- Cerebrovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reiki GroupRemote 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. | Other | Reiki Group |
| Sham Reiki GroupIn 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 |
Primary outcome
Visual Analog Scale(VAS)
Time frame: Pre-test data will be collected before starting the study and post-test data will be collected 1 week later.
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.
1 secondary outcome
McGill Pain Scale - Short Form
Time frame: Pre-test data will be collected before starting the study and post-test data will be collected 1 week later.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No. Once the study is completed, its results will be shared with other researchers once the study data is published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reiki Group in people with Diabetic Neuropathy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma G. BURKEV, PhD student (+90 0352 315 77 00, fatmaburkev@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale(VAS) (time frame: Pre-test data will be collected before starting the study and post-test data will be collected 1 week later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.