[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557250":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":60,"collaborators":24,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":24,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":24,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":90,"whyStopped":24,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Okan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Kamishibai Diabetes Education","EXPERIMENTAL","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.\n\nPatients 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.\n\nAfter 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.\n\nFollow-up information and checks will be provided every 3 months.",[13],"Other: kamishibai education",{"label":15,"type":10,"description":16,"interventionNames":17},"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.\n\nTraining involves a PowerPoint presentation and a whiteboard, based on the Ministry of Health Childhood Diabetes Education guide.\n\nThe 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.\n\nFilling out the forms will take approximately 30 minutes. Follow-up information and checks will be provided every 3 months.",[18],"Other: routine education",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"kamishibai education","Patients in the intervention group will be given Kamishibai diabetes education.",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"routine education","Patients in the control group will be given routine diabetes education.",[15],[22],[31],{"name":32,"affiliation":33,"role":34},"Gülzade Uysal, Assoc.Dr.","Sakarya University of Applied Sciences Faculty of Health Sciences","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":24,"email":40},"Makbule Yelda Karadere Rezaee, Msc.","CONTACT","+905541206527","yyeldakaradere@gmail.com",{"name":32,"role":38,"phone":42,"phoneExt":24,"email":43},"+905052520682","gulzadeuysal@gmail.com",[45],{"facility":46,"status":24,"city":47,"state":48,"zip":49,"country":50,"countryCode":24,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Work","Istanbul","Üsküdar","34674","Turkey (Türkiye)",{"type":52,"coordinates":53},"Point",[54,55],28.94966,41.01384,{"lat":55,"lon":54},[58],{"name":59,"role":38,"phone":39,"phoneExt":24,"email":40},"Makbule Yelda Karadere Rezaee",{"type":34,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Makbule Yelda KARADERE REZAEE","Diabetes Training Nurse","100557250","the-effect-of-kamishibai-diabetes-education-on-knowledge-hba1c-and-quality-of-life-in-children-100557250",false,"NCT06535672","The Effect of Kamishibai Diabetes Education on Knowledge, HbA1c, and Quality of Life in Children","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","Inclusion Criteria:\n\n* The child is 8-12 years old.\n* Diagnosed with Type 1 Diabetes Mellitus (T1DM) for at least 1 year.\n* Followed up on an outpatient basis.\n* The child is using insulin.\n* The child can understand and speak Turkish.\n\nExclusion Criteria:\n\n* Presence of another chronic disease other than T1DM that may affect glycemic control.\n* Using an insulin pump.\n* Having vision and\u002For hearing problems.\n* Having a mental and\u002For neurological problem.\n* Having a diagnosis of a psychiatric disease.",true,"ALL","8 Years","12 Years",{"count":75,"type":76},60,"ESTIMATED","INTERVENTIONAL",[79],"NA","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.\n\nThis 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.\n\nHypothesis 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.\n\nHypothesis 2: The Hemoglobin A1c parameter is lower in the Kamishibai-educated group.\n\nHypothesis 3: The quality of life is higher in the Kamishibai-educated group.\n\nThis 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.",[82],"DIABETES EDUCATION",[84,85,86,87,88,89],"Type 1 Diabetes Mellitus (Type 1 DM)","Kamishibai method","Hemoglobin A1c (HbA1c)","Pediatric diabetes education","Quality of life in children","Randomized controlled tria","NOT_YET_RECRUITING","2024-07-30",{"date":93,"type":94},"2024-08-02","ACTUAL",{"date":96,"type":76},"2024-08-10",{"date":98,"type":76},"2025-07-15",{"name":5,"class":6},1]