Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535672
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-13
Brief Title:
The Effect of Kamishibai Diabetes Education on Knowledge HbA1c and Quality of Life in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 methods impact on knowledge levels HbA1c parameters and quality of life
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 methods 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 30 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 n30 intervention n30 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 n30
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 n30
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 Healths Childhood Diabetes Education guide Simple understandable language will be used for childrens 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 N101 followed at Istanbul Zeynep Kâmil Women and Childrens 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 andor hearing problems Having mental andor neurological issues Having a diagnosis of a psychiatric disorder
Exclusion Criteria from the Sample
The child andor 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 childs 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 3197 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 α005 10 beta error β010 and 080 power d0804 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 Childrens 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 260 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 Cronbachs 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 005 will be considered statistically significant
Data Collection Tools The Child Information Form Diabetes Knowledge Level Evaluation Form PedsQL 30 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 n30 intervention n30 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 n30
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 n30
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 Healths Childhood Diabetes Education guide Simple understandable language will be used for childrens 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 N101 followed at Istanbul Zeynep Kâmil Women and Childrens 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 andor hearing problems Having mental andor neurological issues Having a diagnosis of a psychiatric disorder
Exclusion Criteria from the Sample
The child andor 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 childs 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 3197 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 α005 10 beta error β010 and 080 power d0804 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 Childrens 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 260 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 Cronbachs 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 005 will be considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None