Clinical trial NCT05942079: "The Effect of Reiki on Metabolic Parameters in Obese Type 2 Diabetes Patients''
Official title: The Effect of Reiki on Treatment Compliance, Eating Behaviors and Metabolic Values in Obese Individuals With Type 2 Diabetes": Randomized Controlled Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus Type 2 in Obese
Keywords: Reiki
Type 2 DM
Obesity
Eating Behavior
TREATMENT COMPLIANCE BEHAVIORS
NURSING CARE
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 1
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: "Reiki has a positive effect on adherence to treatment, eating behaviors and metabolic values in obese individuals with type 2 diabetes.
timeFrame: 12 weeks
measure: Blood glucose level
timeFrame: 12 weeks
measure: Blood cholesterol level
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
measure: Body mass index
timeFrame: 12 weeks
measure: Belly circumference measurement
timeFrame: 12 weeks
measure: Anxiety level change
timeFrame: 12 weeks
measure: Change in eating behavior
timeFrame: 12 weeks
measure: Change in adherence to treatment
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Harran unv.
city: Şanlıurfa
country: Turkey
facility: Harran Unv
Study officials:
References: