- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07449884
AI Avatar Video vs. Tell-Show-Do for Reducing Anxiety and Improving Cooperation in Children During Local Anesthesia
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
Physiological anxiety measured by heart rate at five standardized time points.
Secondary outcomes:
- Behavioral pain response assessed using the FLACC scale
- Self-reported pain using the Wong-Baker FACES Pain Rating Scale
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rita Melekian, Pediatric dentistry resident
- Phone Number: 71/895228
- Email: rita.melekian@net.usj.edu.lb
Study Locations
-
-
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Beirut, Lebanon
- Recruiting
- Sint Joseph University of Beirut- Pediatric Dentistry clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
- 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:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AI Avatar Video Group
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.
|
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.
|
|
Active Comparator: Tell-Show-Do Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate Changes During Local Anesthesia: Physiological Anxiety Response
Time Frame: 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.
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Immediately before and during local anesthesia administration (single visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Perception During Local Anesthesia Administration
Time Frame: Immediately after local anesthesia administration (same visit)
|
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.
|
Immediately after local anesthesia administration (same visit)
|
|
Child Behavioral Response During Local Anesthesia
Time Frame: During local anesthesia administration (same visit)
|
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.
|
During local anesthesia administration (same visit)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- USJ-CER-2026-07
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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