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CTRI Number  CTRI/2024/07/070525 [Registered on: 12/07/2024] Trial Registered Prospectively
Last Modified On: 12/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [randomized clinical trial ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparative Study Of The Cardâ„¢ System And Tell-Show-Do Technique In The Behaviour Management Of 6–10-Year-Old Children to reduce fear and anxiety. 
Scientific Title of Study   A Comparative Study Of The Cardâ„¢ System And Tell-Show-Do Technique In The Behaviour Management Of 6–10-Year-Old Children. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Asvitha B 
Designation  Post graduate student.  
Affiliation  Chettiand Dental College and Research Institute 
Address  Clinic 6b, Third Floor, Department of Pediatric and Preventive Dentistry, Chettinad Dental College and Research Institute, Kelambakkam, Chennai.

Kancheepuram
TAMIL NADU
603103
India 
Phone  9843578112  
Fax    
Email  asvithameenakshi@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Senthil Eagappan 
Designation  Professor  
Affiliation  Chettinad Dental College and Research Institute 
Address  Clinic 6b, Third Floor, Department of Pediatric and Preventive Dentistry, Chettinad Dental College and Research Institute, Kelambakkam, Chennai.

Kancheepuram
TAMIL NADU
603103
India 
Phone  9894212394  
Fax    
Email  dr.eaga_ars@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Asvitha B 
Designation  Post graduate student 
Affiliation  Chettinad Dental College and Research Institute 
Address  Clinic 6b, Third Floor, Department of Pediatric and Preventive Dentistry, Chettinad Dental College and Research Institute, Kelambakkam, Chennai.

Kancheepuram
TAMIL NADU
6003103
India 
Phone  9843578112  
Fax    
Email  Asvithameenakshi@yahoo.com  
 
Source of Monetary or Material Support  
Clinic 6b, Third Floor, Department of Pediatric and Preventive Dentistry, Chettinad Dental College and Research Institute, Kelambakkam, Chennai. 
 
Primary Sponsor  
Name  Aadarsha Keerthi 
Address  S2, 36/44, Ponniamman Kovil Street,Alandur, Chennai-600016 
Type of Sponsor  Other [self payment ] 
 
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 
DrAsvitha  Chettinad Dental College and Research Institute  Clinic 6b, Third Floor, Department of Pediatric and Preventive Dentistry, Chettinad Dental College and Research Institute, Kelambakkam, Chennai.
Kancheepuram
TAMIL NADU 
9843578112

asvithameenakshi@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICS COMMITTEE - CHETTINAD DENTAL COLLEGE AND RESEARCH INSTITUTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CARD SYSTEM  The CARDâ„¢ system represents a newer approach that empowers children by involving them in the management of their dental anxiety. This system educates children on various evidence-based coping strategies, categorised into four letters: Comfort, Ask, Relax, and Distract. During dental treatment, children are invited to choose their preferred coping interventions from these categories, fostering a sense of control and participation in their care.TIIME: DURING FIRST DENTAL VISIT ONE DAY 
Comparator Agent  Tell Show Do  . Among the various nonpharmacological techniques, the tell-show-do (TSD) technique is one of the most widely used in paediatric dentistry. TSD involves explaining the dental procedures to the child (tell), demonstrating the procedures using models or instruments (show), and then performing the procedure (do). 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  childrens first visit
physically and mentally healthy
children demonstrating positive behaviour according to Wright’s modification of Frankl’s Behavior Rating Scale,
necessitating an inferior alveolar nerve block for dental procedures such as extractions, pulpotomies,
 
 
ExclusionCriteria 
Details  children with prior dental treatment experience,
history of unpleasant dental visits, acute painful oral conditions,
known systemic diseases, recent prolonged hospitalisation, or physical disabilities.
Participants who did not provide informed consent were also excluded from the study.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
to check the effectiveness of card system in reducing the dental fear and anxiety in 6-10 years children  to check the effectiveness of card system in reducing the dental fear and anxiety in 6-10 years children 
 
Secondary Outcome  
Outcome  TimePoints 
Fear & Anxiety determination in the mean value of Spo2 & pulse rate.  Value recorded 10mins before the treatment in the waiting area & 10mins after the dental treatment. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 4 
Date of First Enrollment (India)   23/07/2024 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Dental fear and anxiety are prevalent psychological issues that significantly impact the provision of dental care, particularly in paediatric patients . These reactions can interfere with daily activities and present considerable challenges in delivering adequate dental treatments . Several factors contribute to the development of dental fear and anxiety in children, including previous negative experiences, parental anxiety, and the child’s temperament. Fear of the unknown, the sight and sound of dental instruments, and the potential for pain are common triggers. Dental fear can lead to avoidance of dental care, which exacerbates oral health problems and creates a cycle of increasing anxiety and deteriorating oral health . Therefore, addressing dental fear and anxiety in children is essential for their overall well-being and successful dental treatment outcomes .

 

Various methods have been developed to manage children’s behaviour during dental visits, with nonpharmacological techniques gaining popularity due to their safety and effectiveness . These methods include parental presence and reassurance, distraction, relaxation techniques, systematic desensitisation, modelling, and the use of music or light physical contact. Previous studies have shown that these nonpharmacological techniques can effectively reduce anxiety and improve cooperation in paediatric patients, offering a safer and more holistic approach to managing child dental anxiety compared to pharmacological interventions . Among the various nonpharmacological techniques, the tell-show-do (TSD) technique is one of the most widely used in paediatric dentistry . TSD involves explaining the dental procedures to the child (tell), demonstrating the procedures using models or instruments (show), and then performing the procedure (do). This step-by-step approach aims to familiarise children with dental procedures, reduce their fear through clear communication, and build trust between the dentist and the child. The effectiveness of the TSD technique has been well-documented in previous studies, which have shown that it can significantly reduce anxiety and improve cooperative behaviour in children. Its simplicity and efficacy have made it a popular choice among paediatric dentists for managing child dental anxiety.

 

The CARD™ system represents a newer approach that empowers children by involving them in the management of their dental anxiety. This system educates children on various evidence-based coping strategies, categorised into four letters: Comfort, Ask, Relax, and Distract . During dental treatment, children are invited to choose their preferred coping interventions from these categories, fostering a sense of control and participation in their care. Limited literature is available on the CARD™ system compared to the extensive research on the TSD technique. However, preliminary studies suggest that involving children in selecting coping strategies can enhance their sense of agency and reduce anxiety . The need for this study arises from the lack of comprehensive research comparing the effectiveness of the CARD™ system to the well-established TSD technique. This study aims to fill this gap by systematically evaluating the anxiety levels, physiological parameters, and behavioural responses of children managed with these two techniques, with the primary objective being to compare the effectiveness of the CARD™ system to the tell-show-do technique in managing the behaviour of 6–10-year-old children during dental procedures. Specifically, the study aims to determine which method is more effective in reducing anxiety and enhancing cooperation among paediatric patients. The null hypothesis is that there is no significant difference in the effectiveness of the CARD™ system and the tell-show-do technique in managing child dental anxiety. By systematically assessing anxiety levels and physiological and behavioural parameters before and after the procedures, this study will provide a comprehensive comparison of the two techniques.

 



 
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