AnxietyNCT07449884
AI Avatar Video vs. Tell-Show-Do for Reducing Anxiety and Improving Cooperation in Children During Local Anesthesia
A study testing AI Avatar-Based video and Tell-Show-Do Technique in people with Anxiety and Fear, run by Saint-Joseph University at 1 site in Lebanon.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Fear, Local Anesthesia
- What is being tested?
- AI Avatar-Based video and Tell-Show-Do Technique
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteLebanon
- Study dates
- 16 Feb 2026to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site, 1 recruiting
- Recruiting
Sint Joseph University of Beirut- Pediatric Dentistry clinic
Beirut
About this study
Official 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
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.
Read more
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.
Read the 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.
- Conditions
- Anxiety, Fear, Local Anesthesia, Pediatric Dentistry
- Being tested
- AI Avatar-Based video, Tell-Show-Do Technique
- Keywords
- Artificial intelligence, Child behavior, Dental anxiety, Local anesthesia., Randomized Controlled trial
- Medical subject headings
- Anxiety Disorders, Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI Avatar-Based videoBehavioural
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 TechniqueBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: AI Avatar-Based video |
| 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. Receives: Behavioral: Tell-Show-Do Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately before and during local anesthesia administration (single visit)
Secondary outcomes (2)
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.
Measured: 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.
Measured: During local anesthesia administration (same visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start16 Feb 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449884
- Sponsor's protocol ID
- USJ-CER-2026-07
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07449884
- Acronym / sponsor ID
- USJ-CER-2026-07
- Conditions
- Anxiety, Fear, Local Anesthesia, Pediatric Dentistry
- Keywords
- Artificial intelligence, Child behavior, Dental anxiety, Local anesthesia., Randomized Controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI Avatar Video Group | Experimental | Behavioral: AI Avatar-Based videoParticipants 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. |
| Tell-Show-Do Group | Active comparator | Behavioral: Tell-Show-Do TechniqueParticipants 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. |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
Key exclusion criteria (7 listed)
- History of epilepsy
- Diagnosed anxiety or behavioral disorders
- Cognitive or developmental delay
- Hearing or visual impairment
- Previous experience with dental anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI Avatar-Based videoA 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. | Behavioural | AI Avatar Video Group |
| Tell-Show-Do TechniqueA 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. | Behavioural | Tell-Show-Do Group |
Primary outcome
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.
2 secondary outcomes
Pain Perception During Local Anesthesia Administration
Time frame: Immediately after local anesthesia administration (same visit)
Child Behavioral Response During Local Anesthesia
Time frame: During local anesthesia administration (same visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI Avatar-Based video and Tell-Show-Do Technique in people with Anxiety and Fear, run by Saint-Joseph University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rita Melekian, Pediatric dentistry resident (71/895228, rita.melekian@net.usj.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Changes During Local Anesthesia: Physiological Anxiety Response (time frame: Immediately before and during local anesthesia administration (single visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.