The Effect of Kamishibai Diabetes Education on Knowledge, HbA1c, and Quality of Life in Children

NCT ID: NCT06535672

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-10
• Study Completion Date: 2025-07-15

Brief 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.

Detailed Description

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.

Conditions

DIABETES EDUCATION

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Kamishibai Diabetes Education

Patients in the intervention group will receive diabetes education using the Kamishibai method. This method involves interactive storytelling tailored to the cognitive and sensory development of children aged 8-12. Training will be conducted over 3 days, with 3 sessions each day.

Patients will attend training daily without hospitalization. Training includes interactive storytelling using the Kamishibai method, designed to be engaging and suitable for children aged 8-12.

After the training, participants will complete the Diabetes Knowledge Level Evaluation Form, the PedsQL 3.0 Quality of Life Scale, and the Kamishibai Training Feedback Form. Filling out the forms will take approximately 30 minutes.

Follow-up information and checks will be provided every 3 months.

Group Type: EXPERIMENTAL

kamishibai education

Intervention Type: OTHER

Patients in the intervention group will be given Kamishibai diabetes education.

Routine diabetes education

Patients in the control group will receive routine diabetes education as per standard hospital procedures. This training will also occur over 3 days, with 3 sessions per day.

Training involves a PowerPoint presentation and a whiteboard, based on the Ministry of Health Childhood Diabetes Education guide.

The language used will be simple and understandable for children. The training will be interactive, encouraging feedback and questions. Participants will fill out the Diabetes Knowledge Level Evaluation Form, PedsQL 3.0 Quality of Life Scale, and Routine Education Feedback Form after the training.

Filling out the forms will take approximately 30 minutes. Follow-up information and checks will be provided every 3 months.

Group Type: EXPERIMENTAL

routine education

Intervention Type: OTHER

Patients in the control group will be given routine diabetes education.

Interventions

kamishibai education

Patients in the intervention group will be given Kamishibai diabetes education.

Intervention Type: OTHER

routine education

Patients in the control group will be given routine diabetes education.

Intervention Type: OTHER

Other Intervention Names

Patients in the intervention group will be given Kamishibai diabetes education.

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Okan University

OTHER

Sponsor Role: lead

Responsible Party

Makbule Yelda KARADERE REZAEE

Diabetes Training Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gülzade Uysal, Assoc.Dr.

Role: PRINCIPAL_INVESTIGATOR

Sakarya University of Applied Sciences Faculty of Health Sciences

Locations

Work

Istanbul, Üsküdar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Makbule Yelda Karadere Rezaee, Msc.

Role: CONTACT

yyeldakaradere@gmail.com

+905541206527

Gülzade Uysal, Assoc.Dr.

Role: CONTACT

gulzadeuysal@gmail.com

+905052520682

Facility Contacts

Makbule Yelda Karadere Rezaee

Role: primary

yyeldakaradere@gmail.com

+905541206527

Other Identifiers

2024/99

Identifier Type: -

Identifier Source: org_study_id