FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/095818 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 11/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Helping Kids(4–8 years) Feel Less Scared at the Dentist by Comparing three Ways–Tell-Show-Do, Reverse Tell-Show-Do, and Reverse Tell-Show-Do with Video Demonstration 
Scientific Title of Study   Comparative evaluation of effectiveness of Tell-Show-Do, Reverse Tell-Show-Do and Reverse Tell-Show-Do with Filmed modelling in managing dental anxiety among 4-8 years old children: A Randomized controlled clinical trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sayali Hansraj Patil 
Designation  Post Graduate Student 
Affiliation  JMFs ACPM Dental college  
Address  Department No.5,Building No.2,Department of Pediatric and Preventive Dentistry JMFS ACPM Dental College and Hospital, Sakari Road Dhule

Dhule
MAHARASHTRA
424001
India 
Phone  7840985853  
Fax    
Email  patilsayali876@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prashant Bondarde 
Designation  Professor and HOD 
Affiliation  JMFS ACPM DENTAL COLLEGE 
Address  Department No.5,Building No.2,Department of Pediatric and Preventive Dentistry JMFS ACPM Dental College and Hospital, Sakari Road Dhule
Department No.5,Building No.2,Department of Pediatric and Preventive Dentistry JMFS ACPM Dental College and Hospital, Sakari Road Dhule
Dhule
MAHARASHTRA
424001
India 
Phone  9370309008  
Fax    
Email  bondardeprashant@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sayali Hansraj Patil 
Designation  Post Graduate Student 
Affiliation  JMFs ACPM Dental college and Hospital 
Address  Department No.5,Building No.2,Department of Pediatric and Preventive Dentistry JMFS ACPM Dental College and Hospital
Department No.5,Building No.2,Department of Pediatric and Preventive Dentistry JMFS ACPM Dental College and Hospital
Dhule
MAHARASHTRA
424001
India 
Phone  78409 85853  
Fax    
Email  patilsayali876@gmail.com  
 
Source of Monetary or Material Support  
JMFS ACPM Dental College and Hospital Sakari Road Dhule 424001 
 
Primary Sponsor  
Name  Dr Sayali H Patil 
Address  JMFS ACPM Dental College and Hospital Sakari Road Dhule 424001 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sayali Hansraj Patil  JMFS ACPM Dental College  Department No.5,Building No.2,Department of Pediatric and Preventive Dentistry JMFS ACPM Dental College
Dhule
MAHARASHTRA 		 78409 85853

patilsayali876@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee JMFS ACPM Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Tell-Show-Do (TSD)   Tell-Show-Do (TSD) Explanation of the procedure in child-friendly terms. Demonstration on a dental model. Allowing the child to handle dental instruments before treatment. Study will be conducted in single visit appointment of patient for 30 mins  
Intervention  Reverse Tell-Show-Do (RTSD) Reverse Tell-Show-Do (RTSD) with Filmed   Reverse Tell-Show-Do (RTSD) o Use of the instrument directly on anxious patient first.Then show the instrument to patient. Explanation of the procedure in child-friendly terms Reverse Tell-Show-Do (RTSD) with Filmed modelling. Use of the instrument directly on anxious patient first. Then show the instrument to patient. Explanation of the procedure in child-friendly terms using video related to treatment. Study will be conducted in single visit appointment of patient for 30 mins  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1 Children on their first dental visit
2 Preoperative dental anxiety with a Venham Picture Test (VPT) score greater than or equal to 4
3 Presence of carious molar requiring restorative treatment. (ICDAS type 4 and 5)
4 Age group 4–8 years.
5 Child and guardian willing to participate.
 
 
ExclusionCriteria 
Details  1 Medically compromised children (systemic diseases developmental disorders).
2 Previous dental experience.
Preoperative dental anxiety with a Venham Picture Test (VPT) score less than 4
3 ICDAS types (except type 4 and 5)
4 Children or parents unwilling to participate.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To asses which behaviour modification technique is more effective in reducing dental anxiety among anxious child of 4-8yrs   Study will be conducted in single visit appointment of patient and assessment will be done at baseline, intraoperative and postoperative 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   20/10/2025 
Date of Study Completion (India) 11/04/2026 
Date of First Enrollment (Global)  20/10/2025 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Publication sent for peer review journal 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

This study is a randomized controlled clinical trial comparing three behavior management techniques Tell Show Do (TSD), Reverse Tell Show Do (RTSD), and RTSD with Filmed Modeling for managing dental anxiety in children aged 4 to 8 years.

  • Aim: To evaluate and compare the effectiveness of these three techniques in reducing dental anxiety and improving cooperation.

  • Methodology: 45 children (15 per group) with moderate to high anxiety (VPT score 4 or more) were randomly allocated to one of the three groups. Anxiety was assessed before and after treatment using Venham Picture Test and physiological parameters (pulse rate, SpO2).

  • Intervention:

    • TSD: Explain then Show then Do procedure.

    • RTSD: Do first then Show then Explain.

    • RTSD with FM: Child first watches a video model then RTSD is applied.

  • Outcome Measures: Anxiety reduction, time to cooperate, physiological changes.

  • Analysis: One way ANOVA or Kruskal Wallis test with post hoc pairwise comparisons.

  • Results: Subsequent to the intervention, all three groups showed statistically significant decrease in VPT scores and pulse rate. While RTSD and RTSD+FM demonstrated greater mean VPT reductions than TSD, RTSD had the largest mean pulse rate reduction. However, neither the VPT score nor the pulse rate showed statistically significant intergroup differences.


 
Close