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CTRI Number  CTRI/2025/12/099869 [Registered on: 26/12/2025] Trial Registered Prospectively
Last Modified On: 26/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative Evaluation of Pretend Play and Smartphone Dentist Game in Managing Anxiety among Pediatric Dental Patients Aged 4-8 Years 
Scientific Title of Study   Comparative Evaluation of Pretend Play and Smartphone Dentist Game in Managing Dental anxiety in children aged 4 - 8 Years. 
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 Lekhwani 
Designation  Assistant Professor 
Affiliation  DR DY PATIL DENTAL COLLEGE AND HOSPITAL PUNE 
Address  DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY DR DY PATIL DENTAL COLLEGE AND HOSPITAL PIMPRI PUNE 411018

Pune
MAHARASHTRA
411018
India 
Phone  7710920795  
Fax    
Email  priyanka.lekhwani@dpu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Jasmine Kaur 
Designation  student 
Affiliation  DR DY PATIL DENTAL COLLEGE AND HOSPITAL  
Address  Department of Paediatric and Preventive Dentistry Dr DY Patil Dental College and Hospital Pune Pimpri- 411018
Department of Paediatric and Preventive Dentistry Dr DY Patil Dental College and Hospital Pune Pimpri- 411018
Pune
MAHARASHTRA
411018
India 
Phone  9818801149  
Fax    
Email  jasminek419@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jasmine Kaur 
Designation  student 
Affiliation  DR DY PATIL DENTAL COLLEGE AND HOSPITAL  
Address  DR DY PATIL DENTAL COLLEGE AND HOSPITAL PIMPRI PUNE 411018

Pune
MAHARASHTRA
411018
India 
Phone  9818801149  
Fax    
Email  jasminek419@gmail.com  
 
Source of Monetary or Material Support  
ICMR 
 
Primary Sponsor  
Name  Indian Council of Medical Research (ICMR) 
Address  V Ramalingaswami Bhawan PO Box Number 4911 Ansari Nagar New Delhi 110029 India 
Type of Sponsor  Government funding agency 
 
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 
Jasmine Kaur  Dr DY Patil Dental College and Hospital  Department of Paediatric and Preventive Dentistry Dr DY Patil Dental College and Hospital Pune Pimpri- 411018
Pune
MAHARASHTRA 		 9818801149

jasminek419@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE DR DY PATIL DENTAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy human volunteers 
Patients  (1) ICD-10 Condition: F419||Anxiety disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  pretend play  children aged 4 to 8 will undergo a simulated dental procedure using a mock dental setup including dental chair and instruments as part of pretend play to reduce dental anxiety. 
Comparator Agent  smartphone dentist game  children aged 4 to 8 years old will interact with a smartphone based dental simulation game to familiarise them with dental procedures and reduce dental anxiety 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  The inclusion criteria will consist of children aged 4 to 8 years and
those visiting the dentist for the first time and medically fit and cooperative children and children whose
parents provide informed consent and those requiring restorative treatment 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Alternation 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
This study compares pretend play and smartphone dental simulation to find which better reduces dental anxiety in young children. Pretend play helps children understand dental procedures in a safe environment. It gives them a sense of control and reduces fear of the clinic. The findings aim to support age appropriate behaviour management. This will improve cooperation reduce chairside time and make treatment easier. It also helps build a positive dental attitude and supports long term preventive care.  Pre-operative (before intervention) and Post -operative (after dental treatment) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study compares pretend play and smartphone dental simulation to find which better reduces dental anxiety in young children. Pretend play helps children understand dental procedures in a safe environment. It gives them a sense of control and reduces fear of the clinic. The findings aim to support age appropriate behaviour management. This will improve cooperation reduce chairside time and make treatment easier. It also helps build a positive dental attitude and supports long term preventive care.


 
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