| 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 Card™ 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 Card™ 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
|
|
|
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
|
|
|
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.
|
|
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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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