- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07704112
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).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Istanbul, Turquie (Türkiye)
- Istanbul Bilgi University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
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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.
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Aucune intervention: Routine Care
Preschool children received routine pre-procedural care without structured visual preparation.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Procedural Anxiety
Délai: Immediately before, during, and immediately after the medical procedure.
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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.
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Immediately before, during, and immediately after the medical procedure.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Procedural Pain
Délai: Immediately after the medical procedure.
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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.
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Immediately after the medical procedure.
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Post-Procedural Behavioral Changes
Délai: 15 days after the medical procedure.
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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.
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15 days after the medical procedure.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ebru Temizsoy, PhD,RN, Istanbul Bilgi University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
- Essai contrôlé randomisé
- Intelligence artificielle
- Santé numérique
- Enfants d'âge préscolaire
- Intervention non pharmacologique
- Douleur procédurale
- Soins infirmiers pédiatriques
- Anxiété procédurale
- Soin centré sur l'enfant
- mYPAS
- FLACC
- Medical Procedures
- Procedural Preparation
- PHBQ-AS
- Family Health Centers
- Google Gemini
- CapCut
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-40161-037
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
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