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):
Patients in the intervention group will receive Kamishibai diabetes education, completed over 3 days with 3 sessions per day. Post-education data collection forms will be administered, taking approximately 30 minutes to complete. Patients will be informed about follow-up checks and the process for the next 3 months.
Control Group (n=30):
Patients in the control group will receive routine diabetes education over 3 days with 3 sessions per day. The education will use a PowerPoint presentation and a whiteboard according to the Ministry of Health's Childhood Diabetes Education guide. Simple, understandable language will be used for children's comprehension. The education will be interactive, encouraging feedback and questions.
Form and Metabolic Tests Application at the 3rd and 6th Month:
At the 3rd and 6th months post-education, patients attending doctor check-ups will visit the diabetes education unit. HbA1c and data collection forms will be administered 3 and 6 months post-education. Filling out the forms will take approximately 15-20 minutes.
Population and Sample of the Study:
The study population consists of children aged 8-12 years (N=101) followed at Istanbul Zeynep Kâmil Women and Children's Diseases Training and Research Hospital between January 1, 2024, and April 29, 2024. The sample includes patients diagnosed with Type 1 Diabetes who meet the inclusion criteria from the population.
Inclusion Criteria for the Sample:
Children aged 8-12 years Being followed up for at least 1 year with a diagnosis of Type 1 diabetes Being followed as outpatients Using insulin Able to understand and speak Turkish
Exclusion Criteria for the Sample:
Presence of another chronic disease that could affect glycemic control apart from Type 1 diabetes Using an insulin pump Having vision and/or hearing problems Having mental and/or neurological issues Having a diagnosis of a psychiatric disorder
Exclusion Criteria from the Sample:
The child and/or family not wishing to continue the study The child not participating in the entire education program Diagnosis of a different disease affecting glycemic control during the study The child's treatment continuing in another institution Not attending the regular 3-month check-ups Dependent Variables: Patients' diabetes knowledge score, HbA1c values, and Quality of Life Scale score in children with Type 1 Diabetes.
Independent Variables: Diabetes education using the Kamishibai method, routine diabetes education.
Sample Size: Determined using G. POWER 3.1.9.7 (Heinrich-Heine-Universität Düsseldorf, Germany). Values from a study by Alzawahreh and Öztürk (2024) on adolescents diagnosed with T1DM were used for HbA1c scores. With a 5% alpha error (α=0.05), 10% beta error (β=0.10), and 0.80 power (d=0.804), a total of 60 participants (30 in the intervention group, 30 in the control group) were determined. Considering potential losses, the sample size was increased by 10%. The study is planned with 66 children (33 in the intervention group, 33 in the control group).
Data Collection: Written permission was obtained from the Ethics Committee of Zeynep Kamil Women and Children's Diseases Training and Research Hospital and research permission from the Istanbul Governorship Provincial Health Directorate. After explanations to families of eligible children, verbal and written informed consent will be obtained from participants' families. Personal information will be kept confidential, and their privacy will be respected during the study. Data will be collected between July 2024 and July 2025.
Data Analysis: The data will be analyzed using SPSS 26.0 (Statistical Package for Social Science). Arithmetic mean (Mean), standard deviation (SD), minimum and maximum values will be used for continuous variables. Frequency and percentage calculations will be used for categorical variables. Cronbach's alpha coefficient will determine the internal consistency of the scale items. The Kolmogorov-Smirnov test will assess normal data distribution. Non-parametric tests will be used if data do not show normal distribution. "Chi-square" and "Fisher exact" tests will compare groups with categorical data. The "Mann Whitney U" test will compare numerical data between groups and examine differences between scale averages. The "Friedman test" will examine numerical variable differences at different times within a group. "Spearman correlation" analysis will examine the relationship between scales. In all tests, p \< 0.05 will be considered statistically significant.
