The Effect of Kamishibai Diabetes Education on Knowledge, HbA1c, and Quality of Life in Children
NCT Number: NCT06535672
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: DIABETES EDUCATION
Interventions: OTHER: kamishibai education|OTHER: routine education
Sponsor: Okan University
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-08-10
Completion Date: 2025-07-15
Locations: Work, Istanbul, Üsküdar, 34674, Turkey

Summary:
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.

Primary Outcome Measures: Quality of Life Assessed by the PedsQL 3.0 Child Form, 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)., At baseline, three months later, six months later (15 minutes ago)|HbA1c Value Assessed by Blood Test Results, 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., At baseline, three months later, six months later (15 minutes ago)|Diabetes Knowledge Level Assessed by the Diabetes Knowledge Level Evaluation Form, 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., At baseline (5 minutes ago)