An interventional study of AI Avatar-Based video and Tell-Show-Do Technique in Anxiety, Fear and Local Anesthesia, sponsored by Saint-Joseph University. Recruiting at 1 site in Lebanon. Open to participants aged 5 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Saint-Joseph University · Not applicable, Interventional, and Treatment
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.
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:
All injections will follow a standardized protocol and be performed by the same pediatric dentist to ensure consistency.
Primary outcome:
Physiological anxiety measured by heart rate at five standardized time points.
Secondary outcomes:
Behavior during injection will be video recorded for objective scoring by calibrated evaluators.
The study is approved by the Research Ethics Committee of Saint Joseph University of Beirut. Participation is voluntary, and informed consent is obtained from parents or legal guardians.
The objective is to determine whether integrating AI-based behavioral preparation improves anxiety control and cooperation during pediatric dental injections.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 70 is below the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Saint-Joseph University is the lead sponsor of 71 studies on the registry; 11 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: AI Avatar-Based video
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.
Behavioral: Tell-Show-Do Technique
A 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.
A 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.
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.
Time frame: Immediately before and during local anesthesia administration (single visit)
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.
Time frame: Immediately after local anesthesia administration (same visit)
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.
Time frame: During local anesthesia administration (same visit)
Started Feb 2026 (actual). Primary completion is estimated for Apr 2027, 14 months after the start.
Of 3,836 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 14 months is above that.
Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
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