"The Effect of Reiki on Metabolic Parameters in Obese Type 2 Diabetes Patients''

Diabetes Mellitus Type 2 in Obese Clinical Trial

Official title:

The Effect of Reiki on Treatment Compliance, Eating Behaviors and Metabolic Values in Obese Individuals With Type 2 Diabetes": Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942079
• Other study ID #: 2022/076
• Status: Recruiting
• Start date: September 15, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: July 2023
• Source: Hasan Kalyoncu University
• Contact: Fatmaz Zehra FZ KÜÇÜK
• Phone: 05327443029
• Email: zehraklc2015[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: November 1, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Having been diagnosed with Type 2 diabetes at least 6 months ago,

2. Body mass index = 30 kg/m²

3. Being on oral therapy or using insulin,

4. Ability to communicate and read,

5. Volunteering to participate in research

Exclusion Criteria:

1. Not complying with the principle of voluntarism

2. Answering data collection forms incompletely

3. Desire to leave the study at any stage of the study

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2 in Obese
• Diabetes Mellitus, Type 2

Intervention

Other:
• REIKI
Reiki is applied as an alternative and complementary treatment method.

Locations

Country	Name	City	State
Turkey	Harran Unv	Sanliurfa
Turkey	Harran unv.	Sanliurfa

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Reiki has a positive effect on adherence to treatment, eating behaviors and metabolic values in obese individuals with type 2 diabetes.	Metabolic changes in the patient before and after reiki	12 weeks
Primary	Blood glucose level	HbA1c change in the patient before and after reiki	12 weeks
Primary	Blood cholesterol level	Blood cholesterol exchange level	12 weeks
Primary	Blood pressure	Blood pressure status	12 weeks
Primary	Body mass index	Body mass index change	12 weeks
Primary	Belly circumference measurement	waist circumference will be measured with a tape measure	12 weeks
Primary	Anxiety level change	TO BE EVALUATED BY SCALE	12 weeks
Primary	Change in eating behavior	The change in eating behavior will be evaluated with a scale	12 weeks
Primary	Change in adherence to treatment	change in adherence to treatment will be evaluated with a scale	12 weeks