Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Completed NCT07704112

Artificial Intelligence-Supported Visual Guide for Preschool Children Undergoing Medical Procedures

Conditions: Procedural Anxiety, Procedural Pain, Behavioral Changes

Sex: All
Ages: 3 Years – 6 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 110
Sponsor: Istanbul Bilgi University

Location: Istanbul Bilgi University Istanbul

Summary

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).

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07704112). StuddyBuddy aggregates publicly available trial information.