An AI-Assisted Art Therapy Co-Creation Intervention for Symptom Burden, Anxiety, and Emotional Regulation in Pediatric Chemotherapy Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Emotional Regulation
研究概览
简要总结
This randomized controlled trial aims to evaluate the effects of an AI-assisted interactive art therapy co-creation intervention on symptom burden, state anxiety, and emotional regulation in pediatric patients receiving chemotherapy. The study will be conducted as a parallel-group randomized controlled trial at the Pediatric Hematology-Oncology units of Gazi University Health Application and Research Center between February 2026 and May 2027. A total of 60 children aged 10-18 years who are undergoing a new chemotherapy cycle will be randomly assigned to either an intervention group receiving a four-day AI-assisted art-based program or a control group receiving standard care. Outcome measures will be assessed before and after the intervention period. The study aims to provide evidence on the feasibility and effectiveness of a short-term, technology-assisted psychosocial intervention to support emotional well-being in children undergoing chemotherapy.
详细描述
Childhood cancer and its treatment are associated with significant physical and psychological symptom burden, particularly during chemotherapy. Children frequently experience multiple concurrent symptoms such as nausea, pain, fatigue, and sleep disturbances, accompanied by heightened anxiety and emotional distress. These challenges highlight the need for brief, feasible, and developmentally appropriate psychosocial interventions that can be integrated into routine clinical care during active treatment.
This study is designed as a parallel-group randomized controlled trial to examine the effects of an AI-assisted interactive art therapy co-creation intervention on symptom burden, state anxiety, and emotional regulation in pediatric chemotherapy patients. The study will be conducted at the Pediatric Hematology-Oncology units of Gazi University Health Application and Research Center between February 2026 and May 2027.
The study population will consist of children aged 10-18 years who have been receiving cancer treatment for at least six months and are in the first 1-4 days of a new chemotherapy cycle. Eligible participants who meet the inclusion criteria and provide written informed consent (from both the child and parent/legal guardian) will be randomly assigned to either the intervention group or the control group using simple randomization. Randomization will be performed by an independent statistician using an online randomization tool.
The intervention group will receive an AI-assisted interactive art-based program delivered over four consecutive days during chemotherapy, with daily sessions lasting approximately 20-30 minutes. The program is structured into four thematic sessions: (1) creating a sense of safety and introduction through co-created visual artwork with AI, (2) symbolic representation of chemotherapy-related symptoms and coping strategies, (3) exploration of social support and relationships, and (4) future-oriented themes focusing on hope and emotional closure. In each session, children will co-create visual content with AI-generated imagery and complete the artwork with their own drawings.
The control group will receive standard clinical care without any additional psychosocial intervention. Outcome measures will be assessed at baseline (prior to the intervention) and after completion of the four-day program. Data collection tools include a demographic information form, the Symptom Screening in Pediatrics Tool (SSPedi), the State Anxiety Inventory for Children, and the Emotion Regulation Scale for Children.
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
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention, participants and intervention providers cannot be blinded. However, outcome assessment will be performed by a researcher who is blinded to group allocation. The outcome assessor will not be involved in the intervention delivery and will be unaware of participants' group assignments to minimize assessment bias.
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 10 and 18 years of age
- •Have been receiving chemotherapy treatment for at least 6 months
- •Be between days 1 and 4 of a new chemotherapy cycle
- •Be able to communicate in Turkish
- •Be clinically stable
- •The participant and their parent/guardian must consent to participate in the study and provide written consent
排除标准
- •• Severe neurocognitive impairment, severe physical instability, or being under sedation
- •Experiencing a severe traumatic life event unrelated to the disease within the last 6 months
- •Being in the terminal phase clinically
- •Being under clinical observation due to a psychiatric diagnosis
- •Having fatigue, pain, or medical complications that would prevent participation in the intervention
研究组 & 干预措施
Control Group
Received standard care
Intervention Group
Participating in an AI-powered art-based program
干预措施: AI-based art-based program (Other)
结局指标
主要结局
Emotional Regulation
时间窗: Baseline (prior to the intervention) and immediately after completion of the 4-day intervention period
Emotional regulation will be assessed using the Emotion Regulation Questionnaire for Children and Adolescents. This self-report scale evaluates the use of emotional regulation strategies across two subscales: cognitive reappraisal and expressive suppression. The scale consists of 10 items rated on a 5-point Likert scale. Higher subscale scores indicate more frequent use of the corresponding emotional regulation strategy.
Symptom Burden
时间窗: Baseline (prior to the intervention) and immediately after completion of the 4-day intervention period
Symptom burden will be assessed using the Symptom Screening in Pediatrics Tool (SSPedi), a validated self-report instrument for children aged 8-18 years undergoing cancer treatment. The scale includes 15 common physical and psychological symptoms experienced during chemotherapy. Each item is rated on a 5-point Likert scale, with total scores ranging from 0 to 60. Higher scores indicate greater symptom burden and distress.
State Anxiety
时间窗: Baseline (prior to the intervention) and immediately after completion of the 4-day intervention period
State anxiety will be measured using the State Anxiety Inventory for Children, a 20-item self-report scale designed to assess situational anxiety levels in children and adolescents aged 8-18 years. Items are rated on a 4-point Likert scale, with total scores ranging from 20 to 80. Higher scores reflect higher levels of state anxiety.
次要结局
- Intervention Acceptability(Immediately after completion of the intervention)
研究者
Hazal Ozdemir Koyu
Dr. Research Assistant
Gazi University