An AI-Assisted Art Therapy Co-Creation Intervention

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Cancer Chemotherapy-Related Symptoms Anxiety
• Intervention / Treatment: Other: AI-based art-based program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Received standard care
Experimental: Intervention Group; Participating in an AI-powered art-based program	Other: 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 expression. In each session, the child interacts with an AI system to generate visual images based on predefined therapeutic themes and personal emotional input. The child then actively completes and personalizes the AI-generated images using their own drawings, colors, and symbols, facilitating emotional expression and engagement. The four sessions are structured as follows: (1) establishment of a sense of safety and orientation through initial AI-assisted co-created artwork; (2) symbolic represent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional Regulation	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.	Baseline (prior to the intervention) and immediately after completion of the 4-day intervention period
Symptom Burden	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.	Baseline (prior to the intervention) and immediately after completion of the 4-day intervention period
State Anxiety	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.	Baseline (prior to the intervention) and immediately after completion of the 4-day intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Acceptability	Intervention acceptability and participant satisfaction will be assessed using a researcher-developed process evaluation form. Children will rate their perceived comfort, enjoyment, and satisfaction with the intervention on a numeric scale ranging from 0 to 5, with higher scores indicating greater acceptability.	Immediately after completion of the intervention

Collaborators and Investigators

• Sponsor: Gazi University

Publications and helpful links

General Publications

• 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 Symptom Screening Tool (8-18) in SSPedi-Pediatric Patients with Cancer. Clinical and Experimental Health Sciences, 14(3), 827-834. 3. Dupuis, L. L., Vettese, E., Aftandilian, C., Agarwal, V., Baggott, C., Bradfield, S. M., Crellin-Parsons, N., Freyer, D. R., Kelly, K. M., & King, A. A. (2025). Factors Associated With Self-Report Symptom Screening Adherence in Pediatric Cancer Patients. Cancer Medicine, 14(14), e71053. 4. Gerçeker, G. Ö., Bektaş, M., Önal, A., Kudubeş, A. A., & Çeçen, R. E. (2024). The effect of virtual reality distraction and fatigue training on anxiety and fatigue levels in children with cancer: a randomized controlled study. SEMINARS IN ONCOLOGY NURSING, 5. Hinds, P. S., Grossoehme, D. H., & Reeve, B. B. (2023). One Voice Is Good, But More Is Better: Symptom and Toxicity Reporting in Pediatric Oncology. Cancer Nursing, 46(1), 1-2. 6. Hüzmeli, H., Semerci, R., & Kebudi, R. (2024). The effect of therapeutic play on fear, anxiety, and satisfaction levels of pediatric oncology patients receiving chemotherapy. Journal of pediatric nursing, 77, e195-e201. 7. Jibb, L. A., Yu, A., Nanos, S., Malfitano, C., Foran, L., Hunt, K., Malakian, A., Zimmermann, C., Schultebraucks, K., & Pham, N. A. (2025). The Emotion and Symptom-Focused Engagement (EASE) Psychotherapeutic Intervention for Parents of Children With Acute Leukemia: A Feasibility Trial. Psycho-Oncology, 34(11), e70310. 8. Kisecik Sengul, Z., & Kilicarslan, E. (2025). Investigation into the impact of technology-based motivation program applied to children following cancer diagnosis and their families: a r

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2026
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): May 20, 2027

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: chemotherapy; pediatric oncology; AI-assisted intervention; Digital art therapy
• Other Study ID Numbers: 2025-2254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: A decision regarding the sharing of individual participant data has not yet been made. Any future data sharing will be considered following completion of the study, in accordance with ethical approval, participant consent, and applicable data protection regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No