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).
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Istanbul、トルコ(Türkiye)
- Istanbul Bilgi University
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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.
|
|
介入なし:Routine Care
Preschool children received routine pre-procedural care without structured visual preparation.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Procedural Anxiety
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Procedural Pain
時間枠: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
時間枠: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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協力者と研究者
捜査官
- 主任研究者:Ebru Temizsoy, PhD,RN、Istanbul Bilgi University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-40161-037
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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