Diabetes Mellitus, Type 2NCT06617767
The Effect of Reiki in Patients With Type-II Diabetes
A study testing Reiki in people with Diabetes Mellitus, Type 2, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
Trial summary
Aim: To evaluate the effects of Reiki on subjective well-being, happiness, and some metabolic variables in patients with Type-II diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Reiki
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Aug 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Type-II Diabetes Mellitus at least 6 months prior
- Had a BMI ≥ 25kg/m² (overweight or obese)
- HbA1c ≥ 6.5%
Who cannot join
- Being diagnosed with another disease and needing treatment during the data collection process
- Being a Reiki practitioner or instructor
- Using insulin for treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Reiki
- Keywords
- Diabetes Mellitus, Reiki, well-Being, happiness, metabolic control
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReikiOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Reiki | Experimental | The Reiki group received 20 minutes of remote Reiki once a day for 4 consecutive days Receives: Other: Reiki |
| Control | No intervention | No intervention was applied to the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Well-Being
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.
Measured: 3 months
Happiness
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.
Measured: 3 months
Secondary outcomes (8)
HbA1c (%)
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.
Measured: 3 months
Fasting blood glucose level (mg/dL)
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.
Measured: 3 months
Postprandial blood glucose levels (mg/dl)
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.
Measured: 3 months
Body mass index (kg/m2)
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.
Measured: 3 months
LDL-kolesterol (mg/dL)
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.
Measured: 3 months
HDL-kolesterol (mg/dL)
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.
Measured: 3 months
Total kolesterol (mg/dL)
The highest total kolesterol level in the post-test measurements of individuals in the Reiki group was targeted to be 200 mg/dL.
Measured: 3 months
Triglyceride levels (mg/dL)
The highest triglyceride level in the post-test measurements of individuals in the Reiki group was targeted to be 150 mg/dL.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start3 Aug 2022
- Primary completion3 Feb 2023
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Model description
- Single-blind randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulviye Özcan Yüce, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617767
- Sponsor's protocol ID
- 2022/5/2
- Status last verified
- Sep 2024
- First submitted
- 26 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reiki on Subjective Well-being, Happiness, and Some Metabolic Variables in Patients With Type-II Diabetes: Single-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06617767
- Acronym / sponsor ID
- 2022/5/2
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Reiki, well-Being, happiness, metabolic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 27 Sep 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.
Aim: To evaluate the effects of Reiki on subjective well-being, happiness, and some metabolic variables in patients with Type-II diabetes.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Reiki | Experimental | Other: ReikiThe Reiki group received 20 minutes of remote Reiki once a day for 4 consecutive days |
| Control | No intervention | –No intervention was applied to the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with Type-II Diabetes Mellitus at least 6 months prior
- Had a BMI ≥ 25kg/m² (overweight or obese)
- HbA1c ≥ 6.5%
Key exclusion criteria (3 listed)
- Being diagnosed with another disease and needing treatment during the data collection process
- Being a Reiki practitioner or instructor
- Using insulin for treatment
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 |
|---|---|---|
| ReikiThe 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. | Other | Reiki |
Primary outcome
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.
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.
8 secondary outcomes
HbA1c (%)
Time frame: 3 months
Fasting blood glucose level (mg/dL)
Time frame: 3 months
Postprandial blood glucose levels (mg/dl)
Time frame: 3 months
Body mass index (kg/m2)
Time frame: 3 months
LDL-kolesterol (mg/dL)
Time frame: 3 months
HDL-kolesterol (mg/dL)
Time frame: 3 months
Total kolesterol (mg/dL)
Time frame: 3 months
Triglyceride levels (mg/dL)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Diabetes Mellitus, Type 2, run by Osmaniye Korkut Ata 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 27 Sep 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Well-Being (time frame: 3 months). The study lists 2 primary outcomes in all. 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 27 Sep 2024.