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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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

144

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Antalya
      • Alanya、Antalya、土耳其(türkiye)、07425
        • Alanya Alaaddin Keykubat University Faculty of Dentistry

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

是的

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
有源比较器: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.
实验性的: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.
有源比较器: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.
实验性的: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.
有源比较器: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.
实验性的: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.
有源比较器: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Venham's Picture Test (VPT)
大体时间: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)
大体时间: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)

次要结果测量

结果测量
措施说明
大体时间
Modified Child Dental Anxiety Scale - Faces Version (MCDASf)
大体时间: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)
大体时间: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)
大体时间: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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月17日

初级完成 (实际的)

2026年6月8日

研究完成 (实际的)

2026年6月8日

研究注册日期

首次提交

2026年5月13日

首先提交符合 QC 标准的

2026年5月13日

首次发布 (实际的)

2026年5月19日

研究记录更新

最后更新发布 (实际的)

2026年6月16日

上次提交的符合 QC 标准的更新

2026年6月15日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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