Instrument-Specific Effects of an AI-Generated Animated Video Series on Dental Anxiety in Paediatric Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Venham's Picture Test (VPT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: AI-Generated Animated Video Series (Behavioral)
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).
干预措施: Tell-Show-Do (TSD) Technique (Behavioral)
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.
干预措施: AI-Generated Animated Video Series (Behavioral)
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).
干预措施: Tell-Show-Do (TSD) Technique (Behavioral)
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.
干预措施: AI-Generated Animated Video Series (Behavioral)
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).
干预措施: Tell-Show-Do (TSD) Technique (Behavioral)
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.
干预措施: AI-Generated Animated Video Series (Behavioral)
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).
干预措施: Tell-Show-Do (TSD) Technique (Behavioral)
结局指标
主要结局
Venham's Picture Test (VPT)
时间窗: 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).
Facial Image Scale (FIS)
时间窗: 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.
次要结局
- Modified Child Dental Anxiety Scale - Faces Version (MCDASf)(Baseline (T0) and immediately post-intervention (T1))
- Heart Rate (HR)(Baseline (T0) and immediately post-intervention (T1))
- Peripheral Oxygen Saturation (SpO₂)(Baseline (T0) and immediately post-intervention (T1))
研究者
Gül Keskin
Associate Professor Doctor
Alanya Alaaddin Keykubat University