Think-Find-Solve Activities for Insulin Self-Management in Type 1 Diabetes
17. juli 2026 opdateret af: Marmara University
The Effect of Think-Find-Solve Activities on Insulin Self-Management in Children With Type 1 Diabetes: A Randomized Controlled Trial
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Fatma Toksöz Güneş, MsC, PhD Candidate
- Telefonnummer: +905055232738
- E-mail: f.toksoz1996@gmail.com
Studiesteder
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Istanbul, Tyrkiet (Türkiye)
- Marmara University
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Kontakt:
- Marmara University
- Telefonnummer: +905055232738
- E-mail: f.toksoz1996@gmail.com
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- For the child:
Diagnosed with Type 1 diabetes Aged between 8 and 12 years Able to read and write Able to understand and speak Turkish Diagnosed with diabetes for at least one year Regularly attending routine three-month outpatient clinic follow-ups Having no other diseases or medical conditions aside from diabetes The child agrees to participate in the study
-For the Parent: Being the mother or father of the child with Type 1 diabetes Being the primary caregiver responsible for the child Able to read and write Agrees to participate in the study
Exclusion Criteria:
The child uses an insulin pump
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Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Experimental Group
After the pre-test, children in the intervention group will receive the intervention using the "Insulin Self-Management Know-Find-Solve Activity Book," in addition to the standard education provided by diabetes nurses in accordance with the Ministry of Health Diabetes Educator Guide.
The researcher will explain how to use the activity book, and the book will be given to the children to complete at home.
Parents' contact information will be obtained, and children will be asked to complete the activities in the book at least twice a month for 3 months.
Throughout the process, families will be contacted to monitor the implementation of the activities and to obtain feedback on the completed sections.
Questions from children and parents regarding the activities will be answered by the researcher.
Follow-up measurements will be conducted at the end of the 1st and 3rd months after the intervention.
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The Insulin Self-Management Find-Search-Solve Activity Book was developed based on national and international literature to improve insulin-related self-management skills in children aged 8-12 years with type 1 diabetes.
It aims to help children distinguish correct and incorrect insulin practices, take responsibility, make appropriate decisions, and apply their knowledge in daily life.
The erasable and reusable book was designed to be safe and child-friendly.
It contains 19 activities across 22 pages, including puzzles, word searches, matching, coloring, fill-in-the-blanks, true-false questions, riddles, and identification of insulin injection sites.
Six experts evaluated the book, and the overall Content Validity Index calculated using the Davis technique was 0.98.
Following pilot testing, the book will be finalized according to participant feedback.
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Aktiv komparator: Control Group
Children in the control group will not receive any additional intervention other than the standard education provided by diabetes nurses in accordance with the Ministry of Health Diabetes Educator Guide.
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Parents' contact information will be obtained, and the follow-up process will be maintained.
The same data collection tools will be administered at time points parallel to those of the intervention group.
After completion of the study, in line with the principle of ethical equity, children in the control group will also be given the "Insulin Self-Management Know-Find-Solve Activity Book" as a gift.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in insulin self-management level among children with type 1 diabetes
Tidsramme: Baseline, 1 month after the intervention, and 3 months after the intervention
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The primary outcome is the change in insulin treatment-related self-management level of children with type 1 diabetes.
Higher scores will indicate better insulin self-management.
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Baseline, 1 month after the intervention, and 3 months after the intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in parent-reported insulin treatment self-management level of children with type 1 diabetes
Tidsramme: Baseline, 1 month after the intervention, and 3 months after the intervention
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The secondary outcome is the change in parent-reported insulin treatment self-management level of children with type 1 diabetes.
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Baseline, 1 month after the intervention, and 3 months after the intervention
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Validity of the Insulin Self-Management Find-Search-Solve Activity Book
Tidsramme: Baseline
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The validity of the Insulin Self-Management Know-Find-Solve Activity Book will be evaluated as a pre-specified methodological outcome.
Content validity will be assessed based on expert opinions using the Davis technique and the Content Validity Index.
Face validity will be evaluated through pilot implementation with children with type 1 diabetes who meet the inclusion criteria.
Feedback from children will be used to assess the clarity, comprehensibility, and suitability of the activity book.
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Baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 1. Ogle, G. D., Wang, F., Haynes, A., Gregory, G. A., King, T. W., Deng, K., ... & Maniam, J. (2025). Global type 1 diabetes prevalence, incidence, and mortality estimates 2025: Results from the International diabetes Federation Atlas, and the T1D Index Version 3.0. Diabetes Research and Clinical Practice, 112277. 2. T.C. Sağlık Bakanlığı Halk Sağlığı Genel Müdürlüğü,. 2020. Çocukluk Çağı Diyabeti Eğitimci Rehberi.; Ankara. Alban Tanıtım. ISBN 978-975-590-778-9. 3. WHO, 2024. Health literacy. https://www.who.int/news-room/fact-sheets/detail/health-literacy?utm_source=chatgpt.com 4. Catarino M, Charepe Z, Festas C. Promotion of Self-Management of Chronic Disease in Children and Teenagers: Scoping Review. Healthcare (Basel). 2021 Nov 27;9(12):1642. doi: 10.3390/healthcare9121642. PMID: 34946368; PMCID: PMC8701924. 5. Çövener Özçelik, Ç., Aktaş, E., Şen Celasin, N., Karahan Okuroğlu, G., & Şahin, Ş. (2019). The Development and Validation of a Turkish Insulin Treatment Self-management Scale Child Form (Ages 8-18) and Parent Form. Journal of Clinical Research in Pediatric Endocrinology, 11(3), 278-286. https://doi.org/10.4274/jcrpe.galenos.2019.2019.0026 6. Johnson, D., Deterding, S., Kuhn, K.-A., Staneva, A., Stoyanov, S., & Hides, L. (2016). Gamification for health and wellbeing: A systematic review of the literature. Internet Interventions, 6, 89-106. 7. UNICEF 2016. Game-Based & Interactive Learning Activities for Early Years. MINISTRY OF EDUCATION GAME-BASED TEACHING & LEARNING GRADES 1 - 3 Integrated Curriculum TEACHERS' MANUAL 1ST EDITIONErişim: https://www.unicef.org/jamaica/media/4646/file/Game-Based%20Manual.pdf 8. Sarasmita, M. A., Lee, Y. H., Chan, F. Y., & Chen, H. Y. (2024). Digital serious games to promote behavior change in children with chronic diseases: scoping review and development of a self-management learning framework. Journal of Medical Internet Research, 26, e49692. 9. Rafeezadeh, E., Ghaemi, N., HEIDARIAN, M. H., & Rezaeian, A. (2019). Effect of
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
15. juli 2026
Primær færdiggørelse (Anslået)
15. april 2027
Studieafslutning (Anslået)
15. juni 2027
Datoer for studieregistrering
Først indsendt
22. juni 2026
Først indsendt, der opfyldte QC-kriterier
25. juni 2026
Først opslået (Faktiske)
26. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 30.04.2026/123
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