Drawing and Writing Activities in Adolescents With Type 1 Diabetes
Effect of Art-Based Drawing and Writing Activities on Anxiety and Positive and Negative Affect in Adolescents With Type 1 Diabetes: A Parallel-Group Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effects of drawing and writing activities on anxiety and positive and negative affect in adolescents with type 1 diabetes. A total of 50 adolescents aged 9 to 18 years will be randomly assigned to either the intervention or the control group. Participants in the intervention group will take part in a five-day online drawing and writing program, while the control group will receive standard care. Anxiety and positive and negative affect will be assessed before and after the intervention using validated questionnaires. The findings may provide evidence for the use of art-based interventions to support the psychological well-being of adolescents with type 1 diabetes.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Type 1 diabetes is a chronic condition that requires lifelong disease management and may adversely affect the emotional well-being of adolescents. In addition to the physical burden of treatment, adolescents with type 1 diabetes may experience anxiety and fluctuations in positive and negative emotions. Creative, non-pharmacological interventions may facilitate emotional expression and promote psychological adjustment during adolescence.
The aim of this randomized controlled trial is to evaluate the effectiveness of a structured drawing and writing program on anxiety and positive and negative affect in adolescents with type 1 diabetes.
The study is designed as a single-blind, parallel-group randomized controlled trial. Eligible adolescents aged 9 to 18 years with type 1 diabetes will be randomly assigned to either the intervention group or the control group. Participants in the intervention group will receive a structured five-day drawing and writing program in addition to standard diabetes care. The intervention is designed to encourage emotional expression through creative activities, including guided drawing, emotion-focused drawing exercises, and brief reflective writing tasks. Each session will last approximately 25 to 30 minutes and will be delivered individually using standardized instructions.
Participants in the control group will receive standard diabetes care without the drawing and writing intervention.
The primary outcome is anxiety. Secondary outcomes include positive affect and negative affect. Outcome measures will be assessed at baseline and immediately after completion of the intervention using validated self-report instruments.
The findings of this study are expected to provide evidence regarding the effectiveness of an art-based psychosocial intervention for improving the emotional well-being of adolescents living with type 1 diabetes.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Çiğdem SARI ÖZTÜRK, PhD
- Telefonní číslo: 90 312 216 26 63
- E-mail: cigdemsari@gazi.edu.tr
Studijní místa
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Ankara
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Ankara, Ankara, Turecko (Türkiye), 06500
- Nábor
- Ankara Bilkent City Hospital
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Kontakt:
- Cigdem SARI OZTURK, PhD
- Telefonní číslo: +90 312 216 26 63
- E-mail: cigdemsari@gazi.edu.tr
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Vrchní vyšetřovatel:
- cigdem Sari Ozturk, PhD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria Adolescents aged 9 to 18 years. Diagnosed with type 1 diabetes mellitus for at least 6 months. Using an insulin infusion pump. Having access to the internet via a smartphone or computer. Able to understand the study procedures and complete the study questionnaires. Providing written informed assent, with written informed consent obtained from a parent or legal guardian.
Exclusion Criteria Experience of a major life event (e.g., parental divorce, death of a family member, or relocation) within the past 6 months.
Use of a continuous glucose monitoring (CGM) sensor. Diagnosis of a severe psychiatric disorder. Participation in an art-based education or training program within the past 6 months
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Drawing and Writing Intervention
Participants in the experimental group will receive a structured five-day drawing and writing intervention in addition to standard diabetes care. The program consists of individual, guided art-based activities designed to facilitate emotional expression and reflection on living with type 1 diabetes. Each daily session will last approximately 25-30 minutes and includes drawing, emotion-focused creative activities, and brief reflective writing. All sessions will be delivered individually by the same trained researcher using standardized instructions. |
Participants assigned to the intervention group will receive a structured drawing and writing intervention in addition to standard diabetes care. The intervention consists of five individual sessions conducted over five consecutive days, each lasting approximately 25-30 minutes. Guided activities include drawing, emotion-focused art exercises, and brief reflective writing designed to facilitate emotional expression and coping with type 1 diabetes. All sessions are delivered individually by the same trained researcher using standardized instructions. |
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Žádný zásah: Standard care
Participants in the control group will receive standard diabetes care routinely provided at the pediatric endocrinology clinic. They will not participate in the structured drawing and writing intervention during the study period. Outcome assessments will be conducted at the same time points as in the intervention group. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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State Anxiety
Časové okno: Baseline (Day 1, before the intervention) and immediately after completion of the intervention (Day 5).
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State anxiety will be assessed using the State Anxiety Inventory for Children (SAIC). The SAIC is a validated self-report instrument consisting of 20 items scored on a 3-point Likert scale. Total scores range from 20 to 60, with higher scores indicating greater state anxiety. |
Baseline (Day 1, before the intervention) and immediately after completion of the intervention (Day 5).
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State Anxiety
Časové okno: Baseline and Day 5 (immediately after completion of the intervention)
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State anxiety will be assessed using the State Anxiety Inventory for Children (SAIC). Scores range from 20 to 60, with higher scores indicating greater state anxiety. |
Baseline and Day 5 (immediately after completion of the intervention)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Positive Affect
Časové okno: Baseline and Day 5 (immediately after completion of the intervention)
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Positive affect will be assessed using the Short Positive and Negative Affect Scale for Children (PANAS-C-SF). Higher scores indicate greater positive affect. |
Baseline and Day 5 (immediately after completion of the intervention)
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Negative Affect
Časové okno: Baseline and Day 5 (immediately after completion of the intervention)
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Negative affect will be assessed using the Short Positive and Negative Affect Scale for Children (PANAS-C-SF). Higher scores indicate greater negative affect. |
Baseline and Day 5 (immediately after completion of the intervention)
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Gazi University
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Individual participant data will not be made publicly available because of privacy and confidentiality considerations and the lack of participant consent for public data sharing.
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Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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