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CTRI Number  CTRI/2024/09/074368 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 28/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of tell show do technique game and cartoon video on anxious patients 
Scientific Title of Study   Comparative Evaluation Of Influence Of Pretreatment Exposure To Pediatric Dental Care Using Tell Show Do Technique,Tiny Dentist Game and Animated Movie In Anxiety Reduction Of 5-12 Years Patients : A Randomizer Cinical 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. Priyanka Kadam 
Designation  Post Graduate 
Affiliation  Mahirishi Markandeshwar College of Dental Science and Research 
Address  Department of Pediatric and Preventive Dentistry,Mahirishi Markandeshwar College of Dental Science and Research

Ambala
HARYANA
133207
India 
Phone  6380971425  
Fax    
Email  priyankakadamsan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. H P Suma Sogi 
Designation  Head of Department 
Affiliation  Mahirishi Markandeshwar College of Dental Science and Research 
Address  Department of Pediatric and Preventive Dentistry,Mahirishi Markandeshwar College of Dental Science and Research

Ambala
HARYANA
133207
India 
Phone  8197793383  
Fax    
Email  hod.pedodontics@mmumullana.org  
 
Details of Contact Person
Public Query  
Name  Dr. Priyanka Kadam 
Designation  Post Graduate 
Affiliation  Mahirishi Markandeshwar College of Dental Science and Research 
Address  Department of Pediatric and PReventive Dentistry ,Mahirishi Markandeshwar College of Dental Science and Research

Ambala
HARYANA
133207
India 
Phone  6380971425  
Fax    
Email  priyankakadamsan@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry , MMCDSR, Mullana , Ambala , Haryana , India 133207 
 
Primary Sponsor  
Name  Dr Priyanka Kadam 
Address  Department of Pediatric and Preventive Dentistry,MMCDSR , Mullana, Amabla , Haryana, India 133207 
Type of Sponsor  Other [NIL] 
 
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 Priyanka Kadam  Maharishi Marakandeshwar College of Dental Science and Research  Room no. 4 Department of Pediatric and Preventive Dentistry , MMCDSR
Ambala
HARYANA 		 6380971425

priyankakadamsan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee , Maharishi Markandeshwar Institute of Medical Sciences and Research , Mullana , Ambala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R458||Other symptoms and signs involvingemotional state,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cartoon video , Tiny Dentist Game   30 minutes - cartoon video 30 minutes - Tiny Dentist Game  
Comparator Agent  Tell Show Do Technique  30 minutes 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Healthy children of the age group 5-12 years visiting the department to undergo routine dental
treatments.2.Patients with no previous dental experience.3.Children with Frankl behavior rating 2 and 3.  
 
ExclusionCriteria 
Details  1.Children requiring parental attention.2.Children suffering from any systemic or mental ailments. 3.Guardians without Android-compatible devices. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction of anxiety rate in patients.  1 hour 
 
Secondary Outcome  
Outcome  TimePoints 
modification of behaviour in patients  1 hour 
 
Target Sample Size   Total Sample Size="39"
Sample Size from India="39" 
Final Enrollment numbers achieved (Total)= "39"
Final Enrollment numbers achieved (India)="39" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/10/2024 
Date of Study Completion (India) 20/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [priyankakadamsan@gmail.com].

  6. For how long will this data be available start date provided 20-09-2024 and end date provided 20-09-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 This study is a randomized clinical trial , single blinded trial comparing the Influence of Pretreatment Exposure to Pediatric Dental Care using Tell Show Do Technique, Tiny Dentist Game and Animated movie in Anxiety Reduction of 5-12 years Patients that was conducted in Department of Pediatric and Preventive Dentistry , MMCDSR , Mullana , Haryana with the sample size of 39.  Findings revealed that both the Tiny Dentist Game and animated films were substantially more successful than the traditional Tell-Show-Do method in reducing anxiety and pain perception, as well as in promoting positive behavior during treatment. Animated films, specifically, exhibited the most pronounced overall advantage by yielding notable enhancements in both subjective (behavioral, anxiety, and pain assessments) and objective (physiological) indicators. 
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