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NCT Number: NCT07449884

AI Avatar Video vs. Tell-Show-Do for Reducing Anxiety and Improving Cooperation in Children During Local Anesthesia

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Child Behavior Fear Local Anesthesia Mental Disorders Pediatric Dentistry

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sint Joseph University of Beirut- Pediatric Dentistry clinic

Beirut, Lebanon

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

AI Avatar-Based video

Behavioral

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.

Tell-Show-Do Technique

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rita Melekian, Pediatric dentistry resident

CONTACT

[email protected]

71/895228

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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