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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- State Anxiety
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Group allocation was concealed using sequentially numbered, sealed, opaque envelopes until randomization. Participants were enrolled and treated individually to minimize contamination between study groups. Outcome assessment and statistical analyses were performed using coded data. The statistician and outcome assessors were blinded to group allocation. Due to the nature of the intervention, the researcher delivering the intervention was aware of group assignment.
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Drawing and Writing Intervention (Other)
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.
结局指标
主要结局
State Anxiety
时间窗: 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.
State Anxiety
时间窗: 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.
次要结局
- Positive Affect(Baseline and Day 5 (immediately after completion of the intervention))
- Negative Affect(Baseline and Day 5 (immediately after completion of the intervention))
研究者
Çiğdem Sarı Öztürk
Associate Professor
Gazi University