NCT07632547

Brief Summary

This study is the first of its kind to examine the effect of integrating the real oral environment with a video that supports the expressions used during the Tell-Show-Do technique (such as "we will see the cavity," "the cavity will drink juice to fall asleep," and "we will clean the tooth from the cavity"). This approach aims to enhance the Tell-Show-Do technique, build trust with the child, and reduce anxiety at the different stages of dental treatment in the clinical setting.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Apr 2026Aug 2026

Study Start

First participant enrolled

April 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

May 7, 2026

Last Update Submit

June 2, 2026

Conditions

Keywords

Dental anxietyVideo modeling / SimulationTell-Show-Do technique

Outcome Measures

Primary Outcomes (2)

  • Heart Rate

    Assessment tool: Pulse oximeter Measurement unit: Beats per minute (bpm) Assessment time points: Heart rate was assessed during a single dental treatment visit at baseline before treatment, after behavior management, during local anesthetic injection, before and during rubber dam placement, before handpiece use, and during restorative treatment.

    during a single dental treatment visit at baseline before treatment, after behavior management, during local anesthetic injection, before and during rubber dam placement, before handpiece use, and during restorative treatment.

  • Facial Image Scale (FIS)

    Assessment tool: Facial Image Scale questionnaire Measurement unit: Ordinal score (1-5) Assessment time points: Facial Image Scale was assessed during a single dental treatment visit at baseline and during treatment.

    The Facial Image Scale was assessed during a single dental treatment visit at baseline (first visit before intervention) and during dental treatment.

Secondary Outcomes (1)

  • Oxygen Saturation (SpO₂)

    Baseline; after behavior management; during injection; before rubber dam placement; during rubber dam placement; before handpiece use; during treatment during a single dental treatment visit.

Study Arms (2)

Tell-Show-Do behavior management technique

ACTIVE COMPARATOR

Children in this group will receive restorative treatment with following the traditional TSD technique without any visual aids.

Behavioral: Behavioral Treatment

Real-Oral Simulation Video-Assisted Tell-Show-Do Technique

EXPERIMENTAL

Children in this group will receive restorative treatment with following the enhanced Tell-Show-Do technique with a video simulating the real oral environment

Behavioral: Behavioral Treatment

Interventions

This group received treatment guided by the Tell-Show-Do (TSD) method. Each step was explained through simple analogies-referring to local anesthesia as 'sleepy juice' and the rubber dam as a 'trap' for the 'tooth worm.' After the explanation and instrument demonstration, restorative treatment was carried out. The protocol excluded the use of any audiovisual aids. All procedures involved conservative restoration of the mandibular primary molars

Also known as: Tell-Show-Do Technique
Tell-Show-Do behavior management technique

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 4-6 years, with or without previous dental experience.
  • Children with a positive behavior rating according to the Frankl scale.
  • Children with primary molars requiring conservative dental treatment.

You may not qualify if:

  • Children with systemic or mental disorders.
  • Children who received sedative or analgesic medications within the 3 hours prior to the dental visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damascus University

Damascus, Syria

RECRUITING

Related Publications (4)

  • Abbasi H, Saqib M, Jouhar R, Lal A, Ahmed N, Ahmed MA, Alam MK. The Efficacy of Little Lovely Dentist, Dental Song, and Tell-Show-Do Techniques in Alleviating Dental Anxiety in Paediatric Patients: A Clinical Trial. Biomed Res Int. 2021 May 23;2021:1119710. doi: 10.1155/2021/1119710. eCollection 2021.

    PMID: 34124238BACKGROUND
  • Khandelwal D, Kalra N, Tyagi R, Khatri A, Gupta K. Control of Anxiety in Pediatric Patients using "Tell Show Do" Method and Audiovisual Distraction. J Contemp Dent Pract. 2018 Sep 1;19(9):1058-1064.

    PMID: 30287704BACKGROUND
  • Seligman LD, Hovey JD, Chacon K, Ollendick TH. Dental anxiety: An understudied problem in youth. Clin Psychol Rev. 2017 Jul;55:25-40. doi: 10.1016/j.cpr.2017.04.004. Epub 2017 Apr 19.

    PMID: 28478271BACKGROUND
  • Liu Y, Gu Z, Wang Y, Wu Q, Chen V, Xu X, Zhou X. Effect of audiovisual distraction on the management of dental anxiety in children: A systematic review. Int J Paediatr Dent. 2019 Jan;29(1):14-21. doi: 10.1111/ipd.12430. Epub 2018 Oct 26.

    PMID: 30362187BACKGROUND

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Chaza Kouchaji

    Damascus University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2026

First Posted

June 8, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations