NCT07209696

Brief Summary

This study is designed to evaluate strategies for reducing dental anxiety in pediatric patients. The commonly applied "Tell-Show-Do" method involves explaining and demonstrating dental procedures before they are performed. In this randomized controlled trial, three groups of children will be compared: Children who receive only the Tell-Show-Do method, Children who are prepared at home with a storybook prior to receiving the Tell-Show-Do method, Children who are prepared at home with an animation video prior to receiving the Tell-Show-Do method. Children's dental anxiety will be assessed using validated behavioral observation scales, including baseline measurement at the first examination, after preparation, and following completion of dental treatment. The study will determine whether the addition of a storybook or an animation video provides greater effectiveness in reducing dental anxiety compared with the Tell-Show-Do method alone.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

First Submitted

Initial submission to the registry

September 17, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

September 17, 2025

Last Update Submit

March 24, 2026

Conditions

Keywords

Pediatric DentistryBehavior GuidanceTell-Show-DoAnimation Video InterventionJeet Wheel ScaleCFSS-DSSCAN Index

Outcome Measures

Primary Outcomes (1)

  • Change in dental anxiety and cooperation measured by the Jeet Wheel Scale

    The Jeet Wheel Scale (JWS) (Chakraborty et al., 2024) is a validated child-friendly tool for evaluating dental anxiety and cooperation. The scale ranges from 1 to 8, represented by expressive emoji faces from Excited (1) to Shouting (8). Lower scores indicate no or minimal anxiety with good cooperation, whereas higher scores indicate severe anxiety and poor cooperation. Children will be asked to select the emoji that best represents their feelings, and the score will be recorded at each time point.

    Baseline (Day 1, first examination before intervention) Immediately after preparation, before dental treatment (Day 1, pre-treatment) Immediately after completion of dental treatment (Day 1, post-treatment)

Secondary Outcomes (3)

  • Between-group differences in Jeet Wheel scores after behavioral preparation

    Day 1 (Immediately after preparation, before treatment)

  • Proportion of children with high anxiety at post-treatment (Jeet Wheel score ≥ 4)

    Day 1 (Immediately after completion of dental treatment, post-treatment).

  • Safety and acceptability of behavioral preparations

    Throughout the dental visit(s) on Day 1.

Other Outcomes (2)

  • Baseline dental fear assessed by the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS)

    Day 1 (Baseline, before intervention).

  • Baseline need for general anesthesia assessed by the SCAN Index

    Day 1 (Baseline, before intervention).

Study Arms (3)

Tell-Show-Do Only (Control)

ACTIVE COMPARATOR

Children in this arm will receive the standard Tell-Show-Do (TSD) behavioral guidance technique before and during dental treatment. No additional preparation such as storybook or animation video will be provided.

Behavioral: Tell-Show-Do

Storybook + Tell-Show-Do

EXPERIMENTAL

Children in this arm will be prepared at home with a child-friendly storybook that introduces the dental environment, instruments, and treatment steps in an age-appropriate manner. At the clinic, they will then receive the standard Tell-Show-Do (TSD) behavioral guidance technique before and during dental treatment.

Behavioral: Tell-Show-DoBehavioral: Storybook Preparation

Animation Video + Tell-Show-Do

EXPERIMENTAL

Children in this arm will be prepared at home with an age-appropriate animation video introducing the dental environment, instruments, and treatment steps. At the clinic, they will then receive the standard Tell-Show-Do (TSD) behavioral guidance technique before and during dental treatment.

Behavioral: Tell-Show-DoBehavioral: Animation Video Preparation

Interventions

Tell-Show-DoBEHAVIORAL

The conventional behavior guidance technique in pediatric dentistry, where the dentist explains and demonstrates dental procedures before performing them.

Animation Video + Tell-Show-DoStorybook + Tell-Show-DoTell-Show-Do Only (Control)

Home-based preparation using a child-friendly storybook that introduces the dental visit, instruments, and procedures in simple language and illustrations.

Storybook + Tell-Show-Do

The conventional behavior guidance method where the dentist explains and demonstrates dental procedures before performing them, to reduce anxiety and improve cooperation.

Animation Video + Tell-Show-Do

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 4 to 8 years
  • Requiring dental treatment in the pediatric dentistry clinic
  • Classified as cooperative enough for chairside treatment without mandatory general anesthesia
  • Parent or legal guardian able to provide written informed consent
  • Child assent obtained where appropriate -

You may not qualify if:

  • Children with systemic medical conditions that contraindicate routine dental care
  • Children with developmental, cognitive, or behavioral disorders that preclude completion of study procedures
  • Children requiring urgent dental treatment under general anesthesia or sedation
  • Prior exposure to the same storybook or animation video used in the study
  • Parents/guardians who decline to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inönü university faculty of dentistry

Malatya, Battalgazi, 44050, Turkey (Türkiye)

Location

Related Publications (5)

  • Alsaadoon AM, Sulimany AM, Hamdan HM, Murshid EZ. The Use of a Dental Storybook as a Dental Anxiety Reduction Medium among Pediatric Patients: A Randomized Controlled Clinical Trial. Children (Basel). 2022 Mar 1;9(3):328. doi: 10.3390/children9030328.

    PMID: 35327700BACKGROUND
  • Barrera-Avalos C, Luraschi R, Acuna-Castillo C, Vidal M, Mella-Torres A, Inostroza-Molina A, Vera R, Vargas S, Hernandez I, Perez C, Vallejos-Vidal E, Valdes D, Imarai M, Reyes-Lopez FE, Sandino AM. Description of Symptoms Caused by the Infection of the SARS-CoV-2 B.1.621 (Mu) Variant in Patients With Complete CoronaVac Vaccination Scheme: First Case Report From Santiago of Chile. Front Public Health. 2022 Mar 21;10:797569. doi: 10.3389/fpubh.2022.797569. eCollection 2022.

    PMID: 35387187BACKGROUND
  • Wang Q, Chen S, Li Y, Li P, Wu C, Wu Z, Wu Q, Sun F, Li J, Zheng W, Deng C, Zhang F, Li Y. Positive association of genetic variations in the phospholipase C-like 1 gene with dermatomyositis in Chinese Han. Immunol Res. 2016 Feb;64(1):204-12. doi: 10.1007/s12026-015-8738-x.

    PMID: 26603167BACKGROUND
  • Wiley DJ, Grosser S, Qi K, Visscher BR, Beutner K, Strathdee SA, Calhoun B, Palella F, Detels R; Multicenter AIDS Cohort Study Group. Validity of self-reporting of episodes of external genital warts. Clin Infect Dis. 2002 Jul 1;35(1):39-45. doi: 10.1086/340743. Epub 2002 Jun 6.

    PMID: 12060873BACKGROUND
  • Thyne SM, Marmor AK, Madden N, Herrick G. Comprehensive asthma management for underserved children. Paediatr Perinat Epidemiol. 2007 Nov;21 Suppl 3:29-34. doi: 10.1111/j.1365-3016.2007.00882.x.

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The children, parents, and treating dentist were aware of the assigned intervention (storybook, animation video, or Tell-Show-Do only). However, the outcome assessor who rated children's anxiety using the Jeet Wheel scale was blinded to group allocation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of three parallel groups. The control group will receive the Tell-Show-Do (TSD) technique only. The second group will receive storybook preparation at home followed by TSD. The third group will receive animation video preparation at home followed by TSD. Each participant will remain in the assigned group for the duration of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROF LECTURER

Study Record Dates

First Submitted

September 17, 2025

First Posted

October 7, 2025

Study Start

October 1, 2025

Primary Completion

February 28, 2026

Study Completion

March 31, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to privacy and confidentiality concerns in pediatric participants.

Locations