Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06202950 |
| Other study ID # |
2023/70 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2023 |
| Est. completion date |
July 15, 2025 |
Study information
| Verified date |
January 2024 |
| Source |
Hasan Kalyoncu University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 disease.Diabetes 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 and/or
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 536.6 million people
with diabetes worldwide, and this number is expected to increase to 783.2 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 1.99 million, and 1.2 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 thousand.The 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 children/adolescents 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 control.study 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, "50.9% of
the patients had somatization, 47.3% had anxiety, 43.9% had obsession, 33.3% had depression,
37.5% had psychosis, 48.2% had It was determined that there were multiple psychiatric
findings, including anger in 100% of patients and phobia in 28.1%.In the study to examine the
self-concept of children/adolescents 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 children/adolescents; Depression and anxiety levels of children
and adolescents with type 1 diabetes were found to be higher and their psychosocial
relationships were worse.In 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 increase.In 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 Children's 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
7.6% and 8.8% 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 peers.Adolescents 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 child/adolescent 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.
