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Effects of AI-Generated Animated Videos on Dental Anxiety in Children (AIVDAC)

2026年6月15日 更新者:Gül Keskin、Alanya Alaaddin Keykubat University

Instrument-Specific Effects of an AI-Generated Animated Video Series on Dental Anxiety in Paediatric Patients: A Randomized Controlled Trial

The goal of this clinical trial is to evaluate the overall effect of an artificial intelligence-generated, instrument-specific animated video series compared with the conventional Tell-Show-Do (TSD) technique on dental anxiety in children aged 4 to 8 years. The study will also investigate whether the anxiety-reducing effect differs according to the dental instrument introduced.

Researchers will compare the animated video series with the conventional Tell-Show-Do technique across four dental instruments: dental mirror, dental probe, micromotor handpiece, and saliva ejector.

Participants will be randomly assigned to one of the study groups. Children will either watch an instrument-specific animated educational video or receive the Tell-Show-Do technique related to a specific dental instrument. Dental anxiety levels will be evaluated using the Facial Image Scale (FIS), Venham Picture Test (VPT) and Modified Child Dental Anxiety Scale-Faces version (MCDASf), together with pulse rate and oxygen saturation levels, before and after the application procedure.

調査の概要

詳細な説明

This prospective, single-center, randomized controlled clinical trial will evaluate the effectiveness of an artificial intelligence-generated animated educational video series in reducing dental anxiety among children aged 4 to 8 years. The study uses a 2×4 factorial design to compare the animated video series with the conventional Tell-Show-Do (TSD) technique across four commonly used dental instruments: dental mirror, dental probe, micromotor handpiece, and saliva ejector.

Participants will be randomly assigned to one of eight study groups according to intervention type and dental instrument. Only healthy children with no previous dental treatment experience and a Frankl Behavior Rating Scale score of 3 or 4 will be included in the study. Children in the animation groups will watch an instrument-specific animated educational video, while children in the control groups will receive the conventional Tell-Show-Do technique for the same instrument.

Dental anxiety will be assessed using the Facial Image Scale (FIS), Venham Picture Test (VPT), and Modified Child Dental Anxiety Scale-Faces version (MCDASf). Physiological parameters including pulse rate and oxygen saturation levels will also be recorded before and after the application procedure.

The study aims to investigate both the overall effectiveness of the animated educational video series and the instrument-specific differences in anxiety reduction among pediatric dental patients.

研究の種類

介入

入学 (実際)

144

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Antalya
      • Alanya、Antalya、トルコ(Türkiye)、07425
        • Alanya Alaaddin Keykubat University Faculty of Dentistry

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

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

はい

説明

Inclusion Criteria:

  • Age 4-8 years
  • Frankl Behaviour Rating Scale score of 3 or 4 (positive or definitely positive) at initial assessment
  • No previous restorative or surgical dental treatment
  • ASA physical status classification I or II
  • Ability to communicate in Turkish
  • Written informed consent from the parent or legal guardian

Exclusion Criteria:

  • Confirmed neurodevelopmental disorder (e.g., autism spectrum disorder, attention-deficit/hyperactivity disorder)
  • Clinically significant visual or hearing impairment
  • Prior exposure to formal behaviour management conditioning programmes
  • Requirement for emergency dental care at the study appointment

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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:階乗代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Animated Series - Dental Mirror
Children in this arm viewed a single episode of the AI-generated animated video series (~60 seconds) corresponding to the dental mirror, presented on a 10-inch tablet at 60 dB SPL in the dental waiting area prior to clinical examination. The episode features a recurring maternal character and anthropomorphic dental germ characters that hide among tooth surfaces and are revealed and removed by the dental mirror.
An original four-episode animated video series produced using AI-assisted animation tools. Each episode is approximately 60 seconds in duration and is designed around a single dental instrument, featuring a recurring maternal character and anthropomorphic dental germ characters whose mischievous behaviour is resolved through the action of the featured instrument. Each child viewed only the single episode corresponding to the instrument assigned to their group.
アクティブコンパレータ:Tell-Show-Do - Dental Mirror
Children in this arm received the standard Tell-Show-Do technique (~4 minutes) applied specifically to the dental mirror, following a standardised script. The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do).
The standard Tell-Show-Do technique applied specifically to the instrument assigned to each group. The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do). Each TSD session lasted approximately 4 minutes, matching the viewing time of the single animated episode in the intervention condition.
実験的:Animated Series - Dental Probe
Children in this arm viewed a single episode of the AI-generated animated video series (~60 seconds) corresponding to the dental probe. The episode features a recurring maternal character and anthropomorphic dental germ characters that jump between teeth and become wedged in interproximal spaces, then are dislodged and removed by the dental probe.
An original four-episode animated video series produced using AI-assisted animation tools. Each episode is approximately 60 seconds in duration and is designed around a single dental instrument, featuring a recurring maternal character and anthropomorphic dental germ characters whose mischievous behaviour is resolved through the action of the featured instrument. Each child viewed only the single episode corresponding to the instrument assigned to their group.
アクティブコンパレータ:Tell-Show-Do - Dental Probe
Children in this arm received the standard Tell-Show-Do technique (~4 minutes) applied specifically to the dental probe, following a standardised script. The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do).
The standard Tell-Show-Do technique applied specifically to the instrument assigned to each group. The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do). Each TSD session lasted approximately 4 minutes, matching the viewing time of the single animated episode in the intervention condition.
実験的:Animated Series - Micromotor Handpiece
Children in this arm viewed a single episode of the AI-generated animated video series (~60 seconds) corresponding to the micromotor handpiece. The episode features a recurring maternal character and anthropomorphic dental germ characters that eat and rest on a tooth surface, then are tickled and removed by the micromotor handpiece.
An original four-episode animated video series produced using AI-assisted animation tools. Each episode is approximately 60 seconds in duration and is designed around a single dental instrument, featuring a recurring maternal character and anthropomorphic dental germ characters whose mischievous behaviour is resolved through the action of the featured instrument. Each child viewed only the single episode corresponding to the instrument assigned to their group.
アクティブコンパレータ:Tell-Show-Do - Micromotor Handpiece
Children in this arm received the standard Tell-Show-Do technique (~4 minutes) applied specifically to the micromotor handpiece, following a standardised script. The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do).
The standard Tell-Show-Do technique applied specifically to the instrument assigned to each group. The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do). Each TSD session lasted approximately 4 minutes, matching the viewing time of the single animated episode in the intervention condition.
実験的:Animated Series - Saliva Ejector
Children in this arm viewed a single episode of the AI-generated animated video series (~60 seconds) corresponding to the saliva ejector. The episode features a recurring maternal character and anthropomorphic dental germ characters that flood the mouth with water and swim freely, then are eliminated by the suction of the saliva ejector.
An original four-episode animated video series produced using AI-assisted animation tools. Each episode is approximately 60 seconds in duration and is designed around a single dental instrument, featuring a recurring maternal character and anthropomorphic dental germ characters whose mischievous behaviour is resolved through the action of the featured instrument. Each child viewed only the single episode corresponding to the instrument assigned to their group.
アクティブコンパレータ:Tell-Show-Do - Saliva Ejector
Children in this arm received the standard Tell-Show-Do technique (~4 minutes) applied specifically to the saliva ejector, following a standardised script. The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do).
The standard Tell-Show-Do technique applied specifically to the instrument assigned to each group. The clinician verbally described the instrument's name, appearance, and function using age-appropriate language (Tell); demonstrated it on the child's hand before approaching the mouth (Show); and applied it intra-orally (Do). Each TSD session lasted approximately 4 minutes, matching the viewing time of the single animated episode in the intervention condition.

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
Venham's Picture Test (VPT)
時間枠:Baseline (T0) and immediately post-intervention (T1)
An eight-item pictorial anxiety measure requiring children to select the image (anxious or non-anxious figure) that best represents their feelings (score range 0-8).
Baseline (T0) and immediately post-intervention (T1)
Facial Image Scale (FIS)
時間枠:Baseline (T0) and immediately post-intervention (T1)
A five-item pictorial self-report scale depicting faces ranging from very happy (1) to very unhappy (5), validated for use in children aged ≥ 4 years with limited literacy.
Baseline (T0) and immediately post-intervention (T1)

二次結果の測定

結果測定
メジャーの説明
時間枠
Modified Child Dental Anxiety Scale - Faces Version (MCDASf)
時間枠:Baseline (T0) and immediately post-intervention (T1)
A six-item self-report scale using facial images (score range 6-30), validated for the paediatric dental setting.
Baseline (T0) and immediately post-intervention (T1)
Heart Rate (HR)
時間枠:Baseline (T0) and immediately post-intervention (T1)
Measured using a paediatric pulse oximeter positioned on the index finger of the non-dominant hand. The mean of two consecutive readings was used for analysis.
Baseline (T0) and immediately post-intervention (T1)
Peripheral Oxygen Saturation (SpO₂)
時間枠:Baseline (T0) and immediately post-intervention (T1)
Measured using a paediatric pulse oximeter positioned on the index finger of the non-dominant hand. The mean of two consecutive readings was used for analysis.
Baseline (T0) and immediately post-intervention (T1)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年2月17日

一次修了 (実際)

2026年6月8日

研究の完了 (実際)

2026年6月8日

試験登録日

最初に提出

2026年5月13日

QC基準を満たした最初の提出物

2026年5月13日

最初の投稿 (実際)

2026年5月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月16日

QC基準を満たした最後の更新が送信されました

2026年6月15日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

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?

いいえ

IPD プランの説明

Individual participant data will not be shared publicly due to ethical considerations related to pediatric participants and institutional data protection policies. De-identified aggregate data may be reported in publications.

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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