About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children aged 5 to 7 years
Medically healthy (ASA I)
Cooperative behavior during dental examination
No known allergy to local anesthetics
Disqualifiers
History of epilepsy
Diagnosed anxiety or behavioral disorders
Cognitive or developmental delay
Hearing or visual impairment
Trial design
Parallel
Treatments tested in this trial
AI Avatar-Based video
BehavioralA pre-recorded artificial intelligence-driven avatar-based educational video shown to children prior to administration of local anesthesia. The video explains the injection procedure in simple, age-appropriate language to reduce dental anxiety and improve cooperation.
Tell-Show-Do Technique
BehavioralA conventional behavior management technique used in pediatric dentistry in which the dentist tells the child about the procedure, shows the instruments in a non-threatening way, and then performs the treatment. This method aims to reduce anxiety and improve cooperation during local anesthesia administration.
Treatment groups
Trial outcomes
Primary outcomes
Heart Rate Changes During Local Anesthesia: Physiological Anxiety Response
Heart rate will be measured using a pulse oximeter before and during local anesthesia administration to assess physiological anxiety response.
Secondary outcomes
Pain Perception During Local Anesthesia Administration
Pain will be assessed immediately after local anesthesia administration using the Wong-Baker FACES Pain Rating Scale. This scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst pain possible." Higher scores represent greater perceived pain. Scores will be recorded and compared between the two groups.
Child Behavioral Response During Local Anesthesia
Child behavior during local anesthesia will be evaluated using the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Pain Assessment Scale. The FLACC scale ranges from 0 to 10, with 0 indicating relaxed/comfortable behavior and 10 indicating severe pain or distress. Higher scores represent greater behavioral distress or pain. Scores will be recorded during injection and compared between study groups.
Sponsors and contacts
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