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NCT07670572
NA

Think-Find-Solve Activities for Insulin Self-Management in Type 1 Diabetes

Sponsor: Marmara University

View on ClinicalTrials.gov

Summary

Children with type 1 diabetes require lifelong insulin therapy. However, improper management of insulin therapy may lead to serious, potentially life-threatening complications. The aim of this study is to examine the effect of an activity book developed for insulin therapy on insulin self-management among children with type 1 diabetes and their parents. The study is designed as a cluster randomized controlled experimental trial at the center level, including pre-test, 1- month, and 3-month follow-up measurements. The study will be initiated after obtaining ethical approval and institutional permissions. The sample will consist of children aged 8-12 years with type 1 diabetes and their parents. The study will be conducted in two different hospitals in Istanbul; using cluster randomization, one hospital will be assigned to the intervention group and the other to the control group. Prior to the main study, a pilot study will be conducted with 15 participants in each group, and the sample size will be calculated using G\*Power based on the pilot data. Data will be collected using the "Descriptive Information Form for Children with Diabetes" and the "Insulin Treatment Self-Management Scale (ITSMS) - Child (8-18 years) and Parent Forms." The "Find-Solve-Learn Insulin Self-Management Activity Book" will be applied to the children in the intervention group. The children will be monitored to complete the activity book at least twice a month for three months, and feedback will be obtained from their families regarding the process. The data collection process will include pre-test, 1-month, and 3-month follow-up measurements. The obtained data will be analyzed using appropriate statistical methods.

Official title: The Effect of Think-Find-Solve Activities on Insulin Self-Management in Children With Type 1 Diabetes: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

8 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-07-15

Completion Date

2027-06-15

Last Updated

2026-06-26

Healthy Volunteers

No

Interventions

OTHER

Insulin Self-Management Know-Find-Solve Activity Book

The Insulin Self-Management Find-Search-Solve Activity Book was developed by the researchers in line with national and international literature to improve insulin treatment-related self-management skills in children aged 8-12 years with type 1 diabetes. The book aims to support children in distinguishing correct and incorrect practices related to insulin therapy, developing a sense of responsibility, improving decision-making skills, and transferring what they have learned into daily life. It consists of erasable and reusable pages and was designed to be safe and suitable for children's use. The book includes 19 activities and 22 pages, such as puzzles, word searches, matching, coloring, fill-in-the-blanks, true-false questions, riddles, and identifying insulin injection sites. Expert opinions were obtained from six specialists, and the total Content Validity Index calculated using the Davis technique was 0.98. After the pilot implementation, the book will be finalized based on feedbac

Locations (1)

S.B. Marmara University Pendik Training and Research Hospital Prof. Asaf Ataseven Additional Service Building

Istanbul, Turkey (Türkiye)