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

9 de julio de 2026 actualizado por: ebru temizsoy, Istanbul Bilgi University

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).

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

110

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

Sí

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
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.
Sin intervención: Routine Care
Preschool children received routine pre-procedural care without structured visual preparation.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Procedural Anxiety
Periodo de tiempo: Immediately before, during, and immediately after the medical procedure.
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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Procedural Pain
Periodo de tiempo: Immediately after the medical procedure.
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
Periodo de tiempo: 15 days after the medical procedure.
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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Ebru Temizsoy, PhD,RN, Istanbul Bilgi University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

14 de abril de 2026

Finalización primaria (Actual)

15 de mayo de 2026

Finalización del estudio (Actual)

30 de mayo de 2026

Fechas de registro del estudio

Enviado por primera vez

4 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de julio de 2026

Publicado por primera vez (Actual)

15 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Marco de tiempo para compartir IPD

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

Criterios de acceso compartido de IPD

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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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