Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer Chemotherapy-Related Symptoms Anxiety | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI-based art-based program | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Received standard care
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- Participating in an AI-powered art-based program
- interventionNames
- Other: AI-based art-based program
Primary outcomes (3)
- measure
- Emotional Regulation
- timeFrame
- Baseline (prior to the intervention) and immediately after completion of the 4-day intervention period
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULT1. 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