An AI-Assisted Art Therapy Co-Creation Intervention

Официальное название

An AI-Assisted Art Therapy Co-Creation Intervention for Symptom Burden, Anxiety, and Emotional Regulation in Pediatric Chemotherapy Patients: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

The primary objective of this study is to evaluate whether the AI-assisted interactive art intervention reduces symptom burden and state anxiety and improves emotional regulation compared to standard care. The findings are expected to contribute to the development of innovative, short-term, and clinically applicable psychosocial interventions and to provide evidence regarding the use of AI-assisted art-based approaches in pediatric oncology care.

Вмешательства

• Другое AI-based art-based program
  The intervention is an AI-assisted interactive art therapy co-creation program designed to support symptom management, emotional regulation, and anxiety reduction in pediatric patients undergoing chemotherapy. The program is delivered individually during the first 1-4 days of a new chemotherapy cycle and consists of four consecutive daily sessions, each lasting approximately 20-30 minutes. The intervention integrates artificial intelligence-generated visual content with child-led artistic expre

Первичные конечные точки

• Emotional Regulation [Срок оценки: Baseline (prior to the intervention) and immediately after completion of the 4-day intervention period]
• Symptom Burden [Срок оценки: Baseline (prior to the intervention) and immediately after completion of the 4-day intervention period]
• State Anxiety [Срок оценки: Baseline (prior to the intervention) and immediately after completion of the 4-day intervention period]

Вторичные конечные точки (1)

• Intervention Acceptability [Срок оценки: Immediately after completion of the intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 1. Chen, Y., Chen, X., Li, L., Li, Y., Yan, Q., & Hu, X. (2025). The efficacy of virtual reality-based interventions on pain, anxiety, depression, and quality of life among patients with cancer: a meta-analysis of randomized controlled trials. Cancer Nursing, 10.1097. 2. Çelik, R., Törüner, E. K., Altay, N., & Bayram, D. (2024). The Validity-Reliability Study of Turkish Version of Electronical Sym

Идентификаторы

NCT: NCT07362615 · 2025-2254

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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