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临床试验/NCT07449884
NCT07449884招募中不适用

Artificial Intelligence-driven Avatar-based Video vs. Tell-show-do for Reducing Anxiety and Improving Cooperation in Children During Local Anesthesia: a Randomized Controlled Trial

Saint-Joseph University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年2月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
Heart Rate Changes During Local Anesthesia: Physiological Anxiety Response

研究概览

简要总结

This randomized clinical trial aims to compare two behavior guidance techniques used to reduce anxiety in children during local anesthesia injections in dental treatment. The study evaluates the traditional Tell-Show-Do (TSD) technique versus an artificial intelligence (AI)-driven, avatar-based video method called the "Mini Dentist."

Children aged 5 to 7 years who require local anesthesia for routine dental treatment will be randomly assigned to one of two groups. The control group will receive the conventional Tell-Show-Do explanation from the pediatric dentist. The experimental group will watch a short animated video featuring an AI-generated avatar that explains and demonstrates the procedure in a child-friendly manner before the injection.

Anxiety and behavior will be assessed using heart rate monitoring, behavioral observation (FLACC scale), and a self-reported pain scale (Wong-Baker FACES). The goal is to determine whether the AI-based method improves cooperation and reduces anxiety compared to the traditional approach.

Participation is voluntary, and all procedures follow ethical research standards.

详细描述

Dental anxiety is common among children, particularly during local anesthesia injections. The Tell-Show-Do (TSD) technique is widely used in pediatric dentistry to reduce fear by explaining and demonstrating procedures before performing them. However, its effectiveness may vary depending on communication style and child engagement. With increasing exposure to digital media, children may respond more positively to visual and technology-based tools.

This randomized controlled clinical trial will compare traditional TSD with an AI-driven avatar-based video modification ("Mini Dentist") during buccal infiltration anesthesia in children aged 5-7 years receiving local anesthesia for the first time. Eligible children will be randomly assigned (1:1) to:

  • Group A: Traditional Tell-Show-Do
  • Group B: AI-driven avatar-based Tell-Show-Do video

All injections will follow a standardized protocol and be performed by the same pediatric dentist to ensure consistency.

Primary outcome:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria:
  • Children aged 5 to 7 years
  • Medically healthy (ASA I)
  • Cooperative behavior during dental examination
  • No known allergy to local anesthetics
  • Require non-urgent dental treatment under local anesthesia
  • First-time experience receiving local anesthesia
  • Able to understand and communicate

排除标准

  • History of epilepsy
  • Diagnosed anxiety or behavioral disorders
  • Cognitive or developmental delay
  • Hearing or visual impairment
  • Previous experience with dental anesthesia
  • Require inferior alveolar nerve block anesthesia
  • Exclusion Criteria:

研究组 & 干预措施

AI Avatar Video Group

Experimental

Participants in this group will watch an artificial intelligence-driven avatar-based video explaining the local anesthesia procedure before receiving the injection. The video presents the procedure in a child-friendly manner to reduce anxiety and improve cooperation during treatment.

干预措施: AI Avatar-Based video (Behavioral)

Tell-Show-Do Group

Active Comparator

Participants in this group will receive behavior management using the conventional Tell-Show-Do technique before administration of local anesthesia. The dentist will verbally explain, demonstrate, and then perform the procedure according to standard pediatric dental practice.

干预措施: Tell-Show-Do Technique (Behavioral)

结局指标

主要结局

Heart Rate Changes During Local Anesthesia: Physiological Anxiety Response

时间窗: Immediately before and during local anesthesia administration (single visit)

Heart rate will be measured using a pulse oximeter before and during local anesthesia administration to assess physiological anxiety response.

次要结局

  • Pain Perception During Local Anesthesia Administration(Immediately after local anesthesia administration (same visit))
  • Child Behavioral Response During Local Anesthesia(During local anesthesia administration (same visit))

研究者

发起方
Saint-Joseph University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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