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

Effect of an Artificial Intelligence-Supported Visual Guide on Procedural Anxiety, Pain, and Post-Procedural Behavioral Changes in Preschool Children Undergoing Common Medical Procedures: A Multicenter Randomized Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Procedural Pain; Procedural Anxiety; Behavioral Changes
• Intervention / Treatment: Behavioral: AI-Supported Visual Guide

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Istanbul Bilgi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-Supported Visual Guide; Preschool children received the AI-supported visual guide approximately 15 minutes before venous blood sampling, vaccination, injection, or peripheral intravenous catheter insertion in addition to routine care.	Behavioral: AI-Supported Visual Guide; A standardized 1-3-minute, AI-supported, procedure-specific educational video developed using Google Gemini 2.5 Pro and finalized using CapCut. The videos included researcher-developed educational scripts, AI-generated illustrations, and AI-generated voice narration to prepare preschool children for venous blood sampling, vaccination, injection, and peripheral intravenous catheter insertion. The videos were shown approximately 15 minutes before the procedure.
No Intervention: Routine Care; Preschool children received routine pre-procedural care without structured visual preparation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Anxiety	Procedural anxiety measured using the Modified Yale Preoperative Anxiety Scale (mYPAS). The mYPAS total score ranges from 23.3 to 100, with higher scores indicating greater procedural anxiety.	Immediately before, during, and immediately after the medical procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Pain	Procedural pain assessed using the Face, Legs, Activity, Cry, and Consolability (FLACC) Pain Scale. Total scores range from 0 to 10, with higher scores indicating greater procedural pain.	Immediately after the medical procedure.
Post-Procedural Behavioral Changes	Post-procedural behavioral changes assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS). Total scores range from 11 to 55, with higher scores indicating more negative post-procedural behavioral changes.	15 days after the medical procedure.

Collaborators and Investigators

• Sponsor: Istanbul Bilgi University
• Investigators: Principal Investigator: Ebru Temizsoy, PhD,RN, Istanbul Bilgi University

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2026
• Primary Completion (Actual): May 15, 2026
• Study Completion (Actual): May 30, 2026

Study Registration Dates

• First Submitted: July 4, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Artificial Intelligence; Digital Health; Preschool Children; Non-pharmacological Intervention; Procedural Pain; Pediatric Nursing; Procedural Anxiety; Child-Centered Care; mYPAS; FLACC; Medical Procedures; Procedural Preparation; PHBQ-AS; Family Health Centers; Google Gemini; CapCut
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Procedural
• Other Study ID Numbers: 2026-40161-037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 6 months after publication and ending 5 years after publication.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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