The Effect of Diabetes Education Given to Children Diagnosed With Type 1 Diabetes Mellitus Using the Kamishibai Method on Patients' Knowledge Level, HbA1c Parameter, and Quality of Life: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Quality of Life Assessed by the PedsQL 3.0 Child Form
研究概览
简要总结
Children diagnosed with Type 1 Diabetes Mellitus (T1DM) initially receive intensive education with their families. Studies indicate that over time, this initial education becomes routine, reducing its effectiveness and failing to adequately address developmental stages, thus requiring repetition. Current methods involve long and intensive educational sessions in hospitals using the Childhood Diabetes Education Guide. These extended, non-interactive sessions often lead to a loss of motivation, decreased learning efficiency, and negative attitudes among patients and their families.
This study aims to develop an educational tool utilizing the Kamishibai method specifically for children with T1DM aged 8-12. The Kamishibai method is designed to align with their cognitive and sensory development, promoting effective and engaging learning experiences for diabetic patients. By incorporating interactive and visually stimulating elements, Kamishibai seeks to enhance motivation and retention of diabetes education.
Hypothesis 1: Children diagnosed with Type 1 DM have higher knowledge levels in the group educated with the Kamishibai method compared to those receiving routine education.
Hypothesis 2: The Hemoglobin A1c parameter is lower in the Kamishibai-educated group.
Hypothesis 3: The quality of life is higher in the Kamishibai-educated group.
This study will assess the effectiveness of the Kamishibai method by comparing it to routine educational approaches. The detailed protocol includes technical aspects of the intervention, measurement tools, data collection methods, and statistical analysis plans to ensure a comprehensive evaluation of the method's impact on knowledge levels, HbA1c parameters, and quality of life.
详细描述
This study is a randomized controlled trial designed to examine the impact of diabetes education using the Kamishibai method on knowledge levels, HbA1c parameters, and quality of life in children diagnosed with T1DM. The study protocol is detailed below.
Data Collection Tools: The Child Information Form, Diabetes Knowledge Level Evaluation Form, PedsQL 3.0 Quality of Life Scale for Children with Type 1 Diabetes (Child Form), Blood Sugar and HbA1c Monitoring Diary, and Kamishibai Education Feedback Form will be used.
Implementation:
The study data will be collected using a stratified random sampling method. Children aged 8-12 years who meet the inclusion criteria will be stratified by their HbA1c values and divided into two groups by block randomization (n=30 intervention, n=30 control). The intervention group will receive Kamishibai diabetes education, while the control group will receive routine diabetes education. Information about the study will be provided to eligible children and parents. Informed consent will be obtained from those agreeing to participate. Data collection forms will be filled out. Each child will have follow-up diabetes nurse appointments 1 week after the education and doctor appointments 10 days later.
Intervention Group (n=30):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The child is 8-12 years old.
- •Diagnosed with Type 1 Diabetes Mellitus (T1DM) for at least 1 year.
- •Followed up on an outpatient basis.
- •The child is using insulin.
- •The child can understand and speak Turkish.
排除标准
- •Presence of another chronic disease other than T1DM that may affect glycemic control.
- •Using an insulin pump.
- •Having vision and/or hearing problems.
- •Having a mental and/or neurological problem.
- •Having a diagnosis of a psychiatric disease.
结局指标
主要结局
Quality of Life Assessed by the PedsQL 3.0 Child Form
时间窗: At baseline, three months later, six months later (15 minutes ago)
The PedsQL™ 3.0 Diabetes Module, developed by Varni et al. (2003), measures diabetes-specific quality of life in children. The Turkish validity study of this scale was conducted by Ayar and Öztürk (2016). The scale, consisting of a total of 28 items, includes five sub-dimensions: Diabetes-Related Problems (11 items) Treatment Barriers (4 items) Adherence to Treatment (7 items) Worry (3 items) Communication (3 items) The 5-point Likert scale is scored as follows: 0 = Never 1. = Rarely 2. = Sometimes 3. = Often 4. = Always The total score ranges from 0 to 100. As the total score increases, the quality of life also increases. A score of 0 indicates never a problem (100 points), 1 indicates rarely a problem (75 points), 2 indicates sometimes a problem (50 points), 3 indicates often a problem (25 points), and 4 indicates always a problem (0 points).
HbA1c Value Assessed by Blood Test Results
时间窗: At baseline, three months later, six months later (15 minutes ago)
HbA1c is a glycosylated hemoglobin test that provides an average level of blood glucose over a 2-3 month period, indicating the average blood glucose values.
Diabetes Knowledge Level Assessed by the Diabetes Knowledge Level Evaluation Form
时间窗: At baseline (5 minutes ago)
The Diabetes Knowledge Level Evaluation Form is prepared by the researchers based on literature. The form consists of 20 questions covering the following areas: What is diabetes and how is it managed? (Questions 1-3) Insulin and blood sugar control (Question 4) Healthy eating (Questions 5-7) Exercise (Questions 8-10) Management of hyperglycemia and hypoglycemia (Questions 11-13) Diabetes management during illness (Questions 14-16) Diabetes management at school (Questions 17-18) General health and care (Question 19) Prevention of chronic complications (Question 20) Responses can be marked as correct, incorrect, or left blank. Correct answers are scored 1 point, while blank or incorrect answers are scored 0 points. The total knowledge score is calculated out of 20 points.
次要结局
未报告次要终点
研究者
Makbule Yelda KARADERE REZAEE
Diabetes Training Nurse
Okan University