Children frequently experience anxiety, pain, and negative behavioral changes during common medical procedures such as venous blood sampling, vaccination, injection, and peripheral intravenous catheter insertion. Providing developmentally appropriate procedural preparation before these procedures may improve children's experiences and reduce procedure-related distress.

This multicenter randomized controlled trial evaluates the effectiveness of an artificial intelligence (AI)-supported visual guide developed to prepare preschool children aged 3-6 years for common medical procedures. The intervention consists of standardized 1-3-minute procedure-specific educational videos created using Google Gemini 2.5 Pro (Google DeepMind) and finalized using CapCut. The videos incorporate researcher-developed educational scripts, AI-generated illustrations, and AI-generated voice narration to provide child-friendly, visually engaging, and developmentally appropriate procedural preparation.

A total of 110 children are randomly assigned to either an intervention group receiving the AI-supported visual guide before the procedure or a control group receiving routine care. The primary outcome is procedural anxiety assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS). Secondary outcomes include procedural pain measured using the Face, Legs, Activity, Cry, and Consolability (FLACC) Pain Scale and post-procedural behavioral changes measured using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).

Medical procedures such as venous blood sampling, vaccination, injection, and peripheral intravenous catheter insertion are among the most common sources of anxiety and distress in preschool children. Inadequate preparation before these procedures may increase procedural anxiety, pain perception, and negative behavioral responses, potentially affecting future healthcare experiences and treatment adherence. Developmentally appropriate, child-centered educational interventions are recommended to improve children's understanding of medical procedures and reduce procedure-related distress.

Recent advances in artificial intelligence (AI), particularly multimodal generative AI systems, have created new opportunities for developing personalized, engaging, and age-appropriate educational materials. However, evidence regarding the effectiveness of AI-generated visual preparation tools in reducing procedural anxiety, pain, and post-procedural behavioral changes in preschool children remains limited.

This multicenter randomized controlled trial evaluates the effectiveness of an AI-supported visual guide developed specifically for preschool children aged 3-6 years undergoing common medical procedures in family health centers. The intervention consists of standardized procedure-specific educational videos created using Google Gemini 2.5 Pro (Google DeepMind) and finalized using CapCut. Educational scripts are developed by the research team based on evidence related to trauma-informed care, child- and family-centered care, procedural preparation, and non-pharmacological interventions. AI-generated illustrations and voice narration are combined with researcher-developed content to produce four standardized educational videos for venous blood sampling, vaccination, injection, and peripheral intravenous catheter insertion. Each video lasts approximately 1-3 minutes and introduces the healthcare environment, healthcare professionals, medical equipment, procedural steps, and positive reinforcement following completion of the procedure.

Children are randomly assigned to either an intervention group receiving the AI-supported visual guide approximately 15 minutes before the medical procedure or a control group receiving routine care. Procedural anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) before, during, and immediately after the procedure. Procedural pain is assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) Pain Scale, while post-procedural behavioral changes are evaluated 15 days after the procedure using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).

The primary objective of the study is to determine whether AI-supported visual preparation reduces procedural anxiety in preschool children. Secondary objectives are to evaluate its effects on procedural pain and post-procedural behavioral changes. This study is designed to evaluate the effectiveness of AI-assisted, child-centered visual education as a standardized, scalable, and non-pharmacological intervention for procedural preparation in preschool children undergoing common medical procedures.

Inclusion Criteria:

• Children aged 3-6 years.
• Scheduled to undergo venous blood sampling, vaccination, injection, or peripheral intravenous catheter insertion at participating family health centers.
• Able to understand Turkish.
• Parent or legal guardian provided written informed consent.
• Child provided verbal assent when developmentally appropriate.

Exclusion Criteria:

• Diagnosed neurological, developmental, or psychiatric disorders that could interfere with behavioral assessment.
• Visual or hearing impairment preventing participation in the intervention.
• Administration of sedative or analgesic medication before the procedure.
• Previous participation in this study.
• Parent or child unwilling to participate.

De-identified individual participant data underlying the results reported in this study will be made available to qualified researchers upon reasonable request to the corresponding author.

Beginning 6 months after publication and ending 5 years after publication.

Access will be provided to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed by the corresponding author, and de-identified data will be shared after approval and execution of an appropriate data-sharing agreement.