- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05942079
"The Effect of Reiki on Metabolic Parameters in Obese Type 2 Diabetes Patients''
The Effect of Reiki on Treatment Compliance, Eating Behaviors and Metabolic Values in Obese Individuals With Type 2 Diabetes": Randomized Controlled Study
The increase in the prevalence of diabetes and the loss of various organs and functions in the individual as a result of complications caused by diabetes affect the life expectancy and quality of individuals, and cause social and economic losses affecting the whole society. For this reason, the individual management of the diabetic patient is important in terms of ensuring effective participation and compliance in treatment and care. Patients must have knowledge, skills and positive attitudes in order to successfully comply with diabetes treatment. Patients are in compliance with diabetes treatment; they encounter some barriers such as medication barriers, barriers to self-monitoring, knowledge and belief barriers, barriers to diagnosis, barriers in relations with health professionals, barriers to lifestyle change, barriers to coping with diabetes, and barriers to getting advice and support. The American Diabetes Association (ADA) states that self-monitoring of blood sugar is important in ensuring glycemic control and preventing hyperglycemia and asymptomatic hypoglycemia. Reiki is applied as an alternative and complementary treatment method. Reiki application, when used together with pharmacological methods, chronic fatigue, diabetic neuropathy, pain caused by surgery, cancer treatment, symptoms of cardiovascular diseases, emotional disorders such as anxiety, depression, acute or chronic pain, infertility-related problems, neurodegenerative disorders, AIDS, autism and developmental disorders, Crohn's disease, irritable bowel syndrome, traumatic brain injury and has been shown to improve health problems such as fatigue.
In the literature, the effects of reiki have been examined in patient groups with different chronic diseases, but no study has been found on obese individuals with Type 2 diabetes. Therefore, reikinin in obese individuals with Type 2 diabetes; This study is planned to determine whether it has an effect on compliance with diabetes treatment, eating behaviors, anxiety levels and changes in metabolic values.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The increase in the prevalence of diabetes and the loss of various organs and functions in the individual as a result of complications caused by diabetes affect the life expectancy and quality of individuals, and cause social and economic losses affecting the whole society. Diabetes with poor management causes many acute and chronic complications. Keeping diabetes under control seriously affects the occurrence of microvascular and macrovascular complications, which develop over years and seriously affect life. Compliance with diabetes treatment; nutrition therapy, regular exercise program, patient self-monitoring, medication, access to health facilities and patient education. With regular monitoring and monitoring of these parameters, compliance with a successful diabetes treatment is improved. The basis of compliance with diabetes treatment is determined by the attitudes and behaviors of patients regarding their own health. For this reason, the individual management of the diabetic patient is important in terms of ensuring effective participation and compliance in treatment and care. Patients must have knowledge, skills and positive attitudes in order to successfully comply with diabetes treatment. Patients are in compliance with diabetes treatment; they encounter some barriers such as medication barriers, barriers to self-monitoring, knowledge and belief barriers, barriers to diagnosis, barriers in relations with health professionals, barriers to lifestyle change, barriers to coping with diabetes, and barriers to getting advice and support. The inability of the individual to cope with these obstacles adequately causes problems in compliance with diabetes treatment. One of the most important points in compliance with diabetes management and treatment is self-monitoring of blood glucose. The American Diabetes Association (ADA) states that self-monitoring of blood sugar is important in ensuring glycemic control and preventing hyperglycemia and asymptomatic hypoglycemia. HbA1c levels were found to be lower in patients who measured their blood glucose more frequently. In patients with poor diabetes management and persistent hyperglycemia, there is an increase in HbA1c value. A 1% increase in HbA1c value is accepted as a risk in the formation of complications. Reiki is applied as an alternative and complementary treatment method. Reiki application, when used together with pharmacological methods, chronic fatigue, diabetic neuropathy, pain caused by surgery, cancer treatment, symptoms of cardiovascular diseases, emotional disorders such as anxiety, depression, acute or chronic pain, infertility-related problems, neurodegenerative disorders, AIDS, autism and developmental disorders, Crohn's disease, irritable bowel syndrome, traumatic brain injury and has been shown to improve health problems such as fatigue (43).
In the literature, the effects of reiki have been examined in patient groups with different chronic diseases, but no study has been found on obese individuals with Type 2 diabetes. Therefore, reikinin in obese individuals with Type 2 diabetes; This study is planned to determine whether it has an effect on compliance with diabetes treatment, eating behaviors, anxiety levels and changes in metabolic values.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Fatmaz Zehra FZ KÜÇÜK
- Phone Number: 05327443029
- Email: zehraklc2015@gmail.com
Study Contact Backup
- Name: Nermin OLGUN
- Phone Number: 05327443029
- Email: zehraklc2015@gmail.com
Study Locations
-
-
-
Şanlıurfa, Turkey
- Recruiting
- Harran unv.
-
Contact:
- Fatmaz Zehra KÜÇÜK
-
Şanlıurfa, Turkey
- Recruiting
- Harran Unv
-
Contact:
- FATMAZ ZEHRA FZ KÜÇÜK, 1
- Phone Number: 05327443029
- Email: zehraklc2015@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Having been diagnosed with Type 2 diabetes at least 6 months ago,
- Body mass index ≥ 30 kg/m²
- Being on oral therapy or using insulin,
- Ability to communicate and read,
- Volunteering to participate in research
Exclusion Criteria:
- Not complying with the principle of voluntarism
- Answering data collection forms incompletely
- Desire to leave the study at any stage of the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
control group
|
|
group receiving reiki
Individuals who will undergo Reiki for 12 weeks
|
Reiki is applied as an alternative and complementary treatment method.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
"Reiki has a positive effect on adherence to treatment, eating behaviors and metabolic values in obese individuals with type 2 diabetes.
Time Frame: 12 weeks
|
Metabolic changes in the patient before and after reiki
|
12 weeks
|
Blood glucose level
Time Frame: 12 weeks
|
HbA1c change in the patient before and after reiki
|
12 weeks
|
Blood cholesterol level
Time Frame: 12 weeks
|
Blood cholesterol exchange level
|
12 weeks
|
Blood pressure
Time Frame: 12 weeks
|
Blood pressure status
|
12 weeks
|
Body mass index
Time Frame: 12 weeks
|
Body mass index change
|
12 weeks
|
Belly circumference measurement
Time Frame: 12 weeks
|
waist circumference will be measured with a tape measure
|
12 weeks
|
Anxiety level change
Time Frame: 12 weeks
|
TO BE EVALUATED BY SCALE
|
12 weeks
|
Change in eating behavior
Time Frame: 12 weeks
|
The change in eating behavior will be evaluated with a scale
|
12 weeks
|
Change in adherence to treatment
Time Frame: 12 weeks
|
change in adherence to treatment will be evaluated with a scale
|
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/076
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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