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CTRI Number  CTRI/2025/08/092402 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 10/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Two Behavior Techniques to Reduce Dental Anxiety in Children During Dental Treatment 
Scientific Title of Study   Comparative evaluation of the effectiveness of Tell-Show-Ask-Show-Do technique vs Tell-Show- Do Technique in the Management of Dental anxiety in Pediatric dental Patients -A Randomized Controlled Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
07072501-01-15-07-2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Monisha Baskaran 
Designation  Undergraduate 
Affiliation  Tagore dental college and hospital 
Address  Tagore dental college and hospital Department of pediatric and preventive dentistry Rathinamangalam melakottaiyur post chennai 600127

Chennai
TAMIL NADU
600127
India 
Phone  9791140129  
Fax    
Email  monishabaskaran01@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijayakumar M 
Designation  Reader department of pediatric and preventive dentistry 
Affiliation  Tagore dental college and hospital 
Address  Tagore dental college and hospital Department of pediatric and preventive dentistry Rathinamangalam melakottaiyur post chennai 600127

Chennai
TAMIL NADU
600127
India 
Phone  9884411172  
Fax    
Email  drvijaypedo6@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vijayakumar M 
Designation  Reader department of pediatric and preventive dentistry 
Affiliation  Tagore dental college and hospital 
Address  Tagore dental college and hospital Department of pediatric and preventive dentistry Rathinamangalam melakottaiyur post chennai 600127

Chennai
TAMIL NADU
600127
India 
Phone  9884411172  
Fax    
Email  drvijaypedo6@gmail.com  
 
Source of Monetary or Material Support  
Tagore dental college and hospital Department of pediatric and preventive dentistry Rathinamangalam melakottaiyur post chennai 600127 Tamil Nadu India  
 
Primary Sponsor  
Name  Monisha Baskaran 
Address  Tagore dental college and hospital Department of pediatric and preventive dentistry Rathinamangalam melakottaiyur post chennai 600127  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
DR VIJAYAKUMAR M  TAGORE DENTAL COLLEGE AND HOSPITAL DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY RATHINAMANGALAM MELAKOTTAIYUR POST CHENNAI 600127 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Monisha Baskaran  Tagore dental college and hospital  Tagore dental college and hospital Department of pediatric and preventive dentistry Rathinamangalam melakottaiyur post chennai 600127
Chennai
TAMIL NADU 
9791140129

monishabaskaran01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Tagore dental college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ORAL CAVITY 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Tell-Show- Do Technique  The Tell-Show-Do (TSD) technique, introduced by Addelston in 1959, is a conventional behaviour management method. It emphasizes ensuring children are well-informed and verbally guided through procedures (Tell), followed by demonstration through visual, tactile, and auditory means in a non-threatening way (Show), and finally, performing the procedure without deviating from the explanation (Do).It is a single session administered prior to treatment lasting for 15-20 minutes 
Intervention  Tell-Show-Ask-Show-Do technique  The Tell-Show-Ask-Show-Do technique includes a verbal explanation of the procedures using simple, non-threatening language to help children understand the process (Tell). The dentist demonstrates the procedures on a dental model to familiarize children with the procedures (Show), followed by asking to reproduce or repeat the explanation provided by the dentist (Ask). This engages the child, assesses their understanding, encourages participation, and reinforces learning by making them to perform the procedure on the dental model (Show). This will improve the cognitive and neuro motor skill development which is associated with the dental procedure. This improves the child’s behavioural response to treatment. Finally, the procedure is carried out by the dentist without deviating from the what been explained (Do).It is a single session administered prior to treatment lasting for 15-20 minutes 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1. Children of 6 - 10 years of age.
2. Children without any past dental experience.
3. Healthy children who are free of systemic disease.
4. Children are willing to participate in the study.
5. Children who have positive or negative behavior based on Frankl behavior rating scale.
6. Children requiring class 1 restorative procedures 
 
ExclusionCriteria 
Details  1. Children presenting with any of the systemic or mental disorders.
2. Children or parents who refused to participate in the study.
3. Children were definitely positive or definitely negative based on Frankl behavior rating
scale.
4. Children requiring invasive procedures such as local anesthesia. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Physiological Response-Changes in heart rate will be recorded using a heart rate monitor
2.Subjective Anxiety Level-Changes in the RMS-PS scale. 
1.Heart rate recorded baseline, intra operative and immediately post treatment
2.RMS PS SCALE assessed baseline and immediately post treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Behavior & cooperation  Baseline, intra operative & immediately post operative 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/09/2025 
Date of Study Completion (India) 27/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Dental anxiety and fear are the most common challenges faced by dentists in paediatric patients during dental procedures. These are major obstacles that interfere with providing effective dental care to children. Dental anxiety can influence a child’s behaviour. Behaviour management plays a vital role in providing an effective and efficient dental care and to instil a positive dental attitude to the child. The Tell-Show-Do (TSD) technique is a conventional behaviour management method. It emphasizes ensuring children are well-informed and verbally guided through procedures (Tell), followed by demonstration through visual, tactile, and auditory means in a non-threatening way (Show), and finally, performing the procedure without deviating from the explanation (Do). Tell-Show-Ask-Show-Do (TSASD) technique it is new form of behaviour shaping that actively involves the child in the learning process under the concept of learning by doing. The Tell-Show-Ask-Show-Do technique includes a verbal explanation of the procedures using simple, non-threatening language to help children understand the process (Tell). The dentist demonstrates the procedures on a dental model to familiarize children with the procedures (Show), followed by asking to reproduce or repeat the explanation provided by the dentist (Ask). This engages the child, assesses their understanding, encourages participation, and reinforces learning by making them to perform the procedure on the dental model (Show). This will improve the cognitive and neuro motor skill development which is associated with the dental procedure. This improves the child’s behavioural response to treatment. Finally, the procedure is carried out by the dentist without deviating from the what been explained (Do). Therefore, this study aims to assess the effectiveness of the tell-show-ask-show-do technique compared to the tell-show-do technique in managing dental anxiety in pediatric dental patients.

 

OUTCOME MEASURES:

Physiological Response: Changes in heart rate will be recorded before, during, and after the

dental procedure using a heart rate monitor

Subjective Anxiety Level: Changes in the RMS-PS scale (pre- and post-treatment).

 

 
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