- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06617767
The Effect of Reiki in Patients With Type-II Diabetes
September 26, 2024 updated by: Ulviye Özcan Yüce, Osmaniye Korkut Ata University
The Effect of Reiki on Subjective Well-being, Happiness, and Some Metabolic Variables in Patients With Type-II Diabetes: Single-blind Randomized Controlled Trial
Aim: To evaluate the effects of Reiki on subjective well-being, happiness, and some metabolic variables in patients with Type-II diabetes.
Study Overview
Detailed Description
This study, designed as a randomized controlled trial with a pretest-posttest design, was conducted between September 2022 and August 2023 at the Internal Medicine clinic of Kanuni Sultan Süleyman Training and Research Hospital, Istanbul Provincial Health Directorate.
The participants were voluntary individuals who had been diagnosed with Type-II Diabetes Mellitus at least 6 months prior, had a BMI ≥ 25kg/m² (overweight or obese), HbA1c ≥ 6.5%, were following a diabetes-specific diet or using oral antidiabetics, and were neither Reiki practitioners nor instructors.
Randomization was used to assign participants to either the Reiki group or the control group.
During the pretest, participants were asked to complete the Personal Information Form, the Subjective Well-Being Scale (SWS), and the OXFORD Happiness Scale (OHS).
Pre-intervention fasting and postprandial blood glucose levels, HbA1c percentage, body mass index, LDL-HDL/total cholesterol, triglyceride levels, and blood pressure measurements were obtained from the patients' records and documented.The Reiki group received 20 minutes of remote Reiki once a day for 4 consecutive days, while no intervention was applied to the control group.
The Subjective Well-Being Scale and OXFORD Happiness Scale were reapplied to both groups at the first and second months following the intervention, and the metabolic values, along with these scales, were measured again in the third month.
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Osmaniye, Turkey, 80000
- Yüce
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosed with Type-II Diabetes Mellitus at least 6 months prior
- Had a BMI ≥ 25kg/m² (overweight or obese)
- HbA1c ≥ 6.5%
Exclusion Criteria:
- Being diagnosed with another disease and needing treatment during the data collection process
- Being a Reiki practitioner or instructor
- Using insulin for treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Reiki
The Reiki group received 20 minutes of remote Reiki once a day for 4 consecutive days
|
The Reiki group received distant Reiki application to their energy centers for 20 minutes, once a day, for 4 consecutive days, by researchers with Reiki Stage II training under the guidance of a researcher with the Usui Reiki Master & Teacher degree.
|
|
No Intervention: Control
No intervention was applied to the control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective Well-Being
Time Frame: 3 months
|
The Subjective Well-Being Scale is a measurement tool developed to determine the subjective experiences and vitality levels of individuals in terms of feeling lively, energetic and alert, and is based on individuals providing information about themselves.
The seven-item, 7-point Likert-type scale is ranked from 1 (Does not apply to me at all) to 7 (Completely applies to me), and participants are asked to determine the extent to which they agree with the statement in each item.
The scores of all items in the scale can be added to obtain the individual's total subjective vitality score.
The range of scores on the scale varies between 7 and 49.
High scores on the scale indicate that the individual has a high level of subjective vitality.It is expected that the scores that the participants receive from this scale will increase in the final measurement.
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3 months
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Happiness
Time Frame: 3 months
|
OXFORD Happiness scale is a 29-item, 6-point Likert-type scale (1-I completely disagree, 6-I completely agree) developed to measure happiness.
A high score obtained from the scale indicates an increase in the level of happiness.
The scale score range varies between 29-174.
It is expected that the scores that the participants receive from this scale will increase in the final measurement.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HbA1c (%)
Time Frame: 3 months
|
HbA1c, is the main biomarker used to assess long-term glycaemic control in individuals with diabetes.In the final test, this value was targeted to be below the level recorded in the pre test in Reiki gruop.
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3 months
|
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Fasting blood glucose level (mg/dL)
Time Frame: 3 months
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Fasting blood glucose level is the level of glucose in the blood measured after at least 8 hours of overnight fasting.In the final test, this value was targeted to be below the level recorded in the pre test.
|
3 months
|
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Postprandial blood glucose levels (mg/dl)
Time Frame: 3 months
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Postprandial blood sugar is the blood sugar level measured 2 hours after food intake (first bite).
It should not be over 140 mg/dl.In the final test, this value was targeted to be below the level recorded in the first test.
|
3 months
|
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Body mass index (kg/m2)
Time Frame: 3 months
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The study initially included individuals who were overweight or obese (BMI ≥ 25kg/m²).
The aim was to reduce the body mass index of the participants in the Reiki group, measured in the post-test.
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3 months
|
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LDL-kolesterol (mg/dL)
Time Frame: 3 months
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The highest LDL (low density lipoprotein) level in the post-test measurements of individuals in the Reiki group was targeted to be 130 mg/dL.
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3 months
|
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HDL-kolesterol (mg/dL)
Time Frame: 3 months
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The lowest HDL (high density lipoprotein) level in the post-test measurements of individuals in the Reiki group was targeted to be 40 mg/dL for women and 50 mg/dL for men.
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3 months
|
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Total kolesterol (mg/dL)
Time Frame: 3 months
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The highest total kolesterol level in the post-test measurements of individuals in the Reiki group was targeted to be 200 mg/dL.
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3 months
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Triglyceride levels (mg/dL)
Time Frame: 3 months
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The highest triglyceride level in the post-test measurements of individuals in the Reiki group was targeted to be 150 mg/dL.
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3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 3, 2022
Primary Completion (Actual)
February 3, 2023
Study Completion (Actual)
July 31, 2024
Study Registration Dates
First Submitted
September 26, 2024
First Submitted That Met QC Criteria
September 26, 2024
First Posted (Actual)
September 27, 2024
Study Record Updates
Last Update Posted (Actual)
September 27, 2024
Last Update Submitted That Met QC Criteria
September 26, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/5/2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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