Ankara Bilkent City Hospital
Ankara, 06500, Turkey (Türkiye)
Location status: Recruiting
Location contact
Cigdem SARI OZTURK, PhD
CONTACT
cigdem Sari Ozturk, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07830082
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.
Interested in participating?
Request Info9 year–18 year
All sexes
Interventional
Not applicable
Ankara, 06500, Turkey (Türkiye)
Location status: Recruiting
Cigdem SARI OZTURK, PhD
CONTACT
cigdem Sari Ozturk, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
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.
Time frame: Baseline (Day 1, before the intervention) and immediately after completion of the intervention (Day 5).
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.
Time frame: Baseline and Day 5 (immediately after completion of the intervention)
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.
Time frame: Baseline and Day 5 (immediately after completion of the intervention)
Positive affect will be assessed using the Short Positive and Negative Affect Scale for Children (PANAS-C-SF). Higher scores indicate greater positive affect.
Time frame: Baseline and Day 5 (immediately after completion of the intervention)
Negative affect will be assessed using the Short Positive and Negative Affect Scale for Children (PANAS-C-SF). Higher scores indicate greater negative affect.
Contact information is provided by the study sponsor or research team.
Gazi University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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