Viewing Study NCT06202950



Ignite Creation Date: 2024-05-06 @ 7:58 PM
Last Modification Date: 2024-10-26 @ 3:17 PM
Study NCT ID: NCT06202950
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-01-18
First Post: 2024-01-02

Brief Title: Type 1 DiabetesMindfulnessYogaStressHealth QualityGlycemic İndex
Sponsor: Hasan Kalyoncu University
Organization: Hasan Kalyoncu University

Study Overview

Official Title: The Effect of Mindfulness and Yoga on Stress Level Quality of Life and Glycemic Control in Youth With Type 1 Diabetes
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The study will examine the effects of Mindfulness-Based Stress Reduction Program and yoga on stress level quality of life and glycemic control in Youth with Type 1 diabetes
Detailed Description: Chronic disease It is defined as a condition that causes permanent disability is irreversible occurs as a result of pathological changes requires special training long-term care supervision and control for the rehabilitation of the patient and limits daily functions According to the World Health Organization WHO data on chronic diseases Every year 41 million people in the world die due to chronic diseases and it is stated that these numbers correspond to 74 of the deaths in the world Nowadays chronic diseases are becoming an increasing health problem especially for children and adolescents According to WHO the incidence of chronic diseases in adolescence is reported to be 15 According to the report published by the American Academy of Pediatrics APA 10-20 million children and adolescents in the United States USA have some kind of chronic diseaseDiabetes is one of the most common non-communicable chronic diseases globally Diabetes Mellitus DM is a chronic metabolic disease that develops as a result of insufficiency deficiency andor absence of the insulin hormone secreted from beta cells in the pancreas is characterized by hyperglycemia and causes disorders in carbohydrate fat and protein metabolism It has a chronic course and is the most common metabolic disease in childhood Although there are different types of diabetes Type 1 diabetes is common in childhood Type 1 diabetes cases constitute 10-15 of all diabetic patients and this rate is increasing Genetic environmental and autoimmune factors play an important role in the development of Type 1 diabetes The incidence of the disease which is often seen between the ages of 7-15 increases between the ages of 4-6 and 10-14 According to the 10th Diabetes Atlas data published by the International Diabetes Federation in 2021 There are 5366 million people with diabetes worldwide and this number is expected to increase to 7832 million in 2045 It is reported that the number of individuals with diabetes among children and adolescents between the ages of 0-19 worldwide is approximately 199 million and 12 million of this number consists of children and adolescents with Type 1 diabetes In our country it is reported that the number of children and adolescents with Type 1 diabetes between the ages of 0-18 is approximately 17 thousand and the number of adolescents with diabetes between the ages of 10-18 is approximately 13 thousandThe fact that diabetes is a disease that is not easy to manage combined with problems such as estrangement from parents in adolescence increased sense of independence physiological change and peer pressure can cause many difficulties for the adolescent in fulfilling his developmental tasks

In studies conducted with adolescents with type 1 diabetes In the study to determine the quality of life of healthy childrenadolescents with Type 1 diabetes aged 4-15 it was found that the quality of life of children and adolescents with Type 1 diabetes was lower than that of healthy children and adolescents

In order to determine the time management skills of adolescents with Type 1 diabetes and the effect of these skills on metabolic control another study with 69 adolescents with Type 1 diabetes between the ages of 13-19 using the Diabetes Adolescent Diagnosis Form Diabetes Time Management Questionnaire DBYA Habits and Behaviors in Adaptation to Diabetes In the research conducted using the and Information Survey DUADBA Metabolic Control and Daily Record Form It has been stated that adolescents with good time management manage diabetes better and that managing diabetes well does not affect metabolic controlstudy applied the Psychological Symptom Screening Test SCL-90-R to 56 individuals with Type 1 diabetes between the ages of 7 and 21 in order to determine the psychological symptoms and findings of children and adolescents attending a diabetes camp As a result of this research 509 of the patients had somatization 473 had anxiety 439 had obsession 333 had depression 375 had psychosis 482 had It was determined that there were multiple psychiatric findings including anger in 100 of patients and phobia in 281In the study to examine the self-concept of childrenadolescents with Type 1 diabetes and their ways of coping with stress It has been stated that self-concept is higher in those with a short duration of diabetes or 11-15 years than in those with a diabetes duration of 6-10 years and that coping with stress was found to be higher in adolescents aged 14-17 without Type 1 diabetes than in adolescents with diabetes

In the research conducted with 349 adolescents with Type 1 diabetes and 409 healthy individuals between the ages of 6-18 from Kuwait in order to examine the social and psychological conditions of childrenadolescents Depression and anxiety levels of children and adolescents with type 1 diabetes were found to be higher and their psychosocial relationships were worseIn a study to examine the symptoms of depression in adolescents with Type 1 diabetes including 45 male and 72 female adolescents with Type 1 diabetes depressive symptoms were found in 50 of the adolescents It has also been reported that adolescents between the ages of 14 and 16 have more depressive symptoms than younger ones

In the study which the coping skills with anxiety and glycemic control were investigated in adolescents with Type 1 diabetes 145 individuals were studied and the Coping Inventory of Stressful Situations was applied In this study it was found that as the duration of the disease increases anxiety decreases and the ability to cope with the disease increaseIn the study on the prevalence of depression and anxiety in individuals with Type 1 diabetes the Hospital Anxiety and Depression Scale was used In a study conducted with a total of 502 individuals it was found that anxiety was more common than depression in individuals with Type 1 diabetes and depression and anxiety were more common in women than in men

In the study investigating depressive symptoms in children and adolescents with Type 1 diabetes the Childrens Depression Inventory was administered to 145 children and adolescents with Type 1 Diabetes As a result of the research high rates of depression were found in 15 of children and adolescents It has also been reported that depression increases in girls and with increasing age

In the meta-analysis study it was stated that only 51 of patients with Type 2 diabetes reached the hemoglobin A1c HbA1c target of 7 Studies on HbA1c in adolescents with type 1 diabetes are limited in number In the HbA1c study conducted by with 66 071 children and adolescents in 8 high-income countries it was stated that the HbA1c value varied between 76 and 88 and that HbA1c increased significantly during the transition from childhood to adolescence Type 1 diabetes In addition to being a metabolic chronic and organic disease it is also a disease that has a psychosocial dimension Studies have shown that the rate of psychiatric disorders in adults with diabetes varies between 33 and 42 and is 2-3 times higher than the general prevalence rate in society and another study has shown that in children aged 8-17 children and adolescents with insulin-dependent Type 1 diabetes It is stated that they have more mental difficulties than their healthy peersAdolescents with type 1 diabetes experience physical emotional and social problems It is suggested that the reason for this is that both the blood sugar level and its irregularities directly affect the brain and psychological functions and the blood sugar level is affected by psychological and emotional changes A childadolescent with type 1 diabetes is obliged to carry out interventions such as measuring blood sugar more than once a day adjusting the insulin dose and administering insulin for the management of the disease and must cope with this situation Due to all these reasons in adolescents with Type 1 diabetes Depression anxiety disorder decrease in quality of life eating disorder fear of hypoglycemia difficulty in coping and adjustment disorder may develop Positive results are achieved with the Mindfulness-Based Stress Reduction Program and yoga practice which are mind and body-based interventions in the process of coping with the psychosocial and physiological problems experienced by adolescents with type 1 diabetes

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None