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

NCT07704112 | Completed

• 1 other identifier: 2026-40161-037
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Procedural Anxiety; Procedural Pain; Behavioral Changes

Keywords

Artificial Intelligence; Preschool Children; Medical Procedures; Procedural Preparation; Procedural Anxiety; Procedural Pain; PHBQ-AS; mYPAS; FLACC; Pediatric Nursing; Child-Centered Care; Family Health Centers; Randomized Controlled Trial; Non-pharmacological Intervention; Digital Health; Google Gemini; CapCut

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Procedural Pain

  Immediately after the medical procedure.

• Post-Procedural Behavioral Changes

  15 days after the medical procedure.

Study Arms (2)

AI-Supported Visual Guide

EXPERIMENTAL

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

Routine Care

NO INTERVENTION

Preschool children received routine pre-procedural care without structured visual preparation.

Interventions

AI-Supported Visual Guide BEHAVIORAL

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.

AI-Supported Visual Guide

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Bilgi University: lead

Study Sites (1)

Istanbul Bilgi University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ebru Temizsoy, PhD,RN

  İstanbul Bilgi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants were randomly assigned in a 1:1 ratio to either an intervention group receiving an AI-supported procedure-specific visual guide before the medical procedure or a control group receiving routine care. Participants remained in their assigned group throughout the study, and outcomes were compared between the two parallel groups.

Study Record Dates

• First Submitted: July 4, 2026
• First Posted: July 15, 2026
• Study Start: April 14, 2026
• Primary Completion: May 15, 2026
• Study Completion: May 30, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months after publication and ending 5 years after publication.
• 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.

Locations

TU (1)