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An AI-Assisted Art Therapy Co-Creation Intervention

NCT07362615 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-01-23

No results posted yet for this study

Summary

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

  • Pediatric Cancer Chemotherapy-Related Symptoms Anxiety

Interventions

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

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2027-05-20
Completion
2027-05-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07362615 on ClinicalTrials.gov