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CTRI Number  CTRI/2024/09/074206 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 10/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison between Reframing and Tell-Show-Do techniques for managing child behaviour for dental treatment  
Scientific Title of Study   Comparative evaluation of Reframing and Tell-Show-Do behaviour guidance technique in the management of dental anxiety among children aged 6 to 12 years undergoing dental treatment without and with administration of local anesthesia: A single blind randomized clinical study 
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 Vidyavathi H Patil 
Designation  Ph.D research Scholar 
Affiliation  KAHERs KLE VK Institute of Dental Sciences 
Address  Dept. of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences,JNMC Campu, Nehru nagar, Belagavi.
Nehru nagar
Belgaum
KARNATAKA
590010
India 
Phone  09611835828  
Fax    
Email  nisarga_vhp@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shivayogi M Hugar 
Designation  Professor 
Affiliation  KAHERSs KLE VK Institute of Dental Sciences 
Address  Dept. of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences,JNMC Campu, Nehru nagar, Belagavi.

Belgaum
KARNATAKA
590010
India 
Phone  9986436448  
Fax    
Email  drhugarsm@kledental-bgm.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Vidyavathi H Patil 
Designation  Ph.D research Scholar 
Affiliation  KAHERs KLE VK Institute of Dental Sciences 
Address  Dept. of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences,JNMC Campu, Nehru nagar, Belagavi.
JNMC Campus Nehru nagar
Belgaum
KARNATAKA
590010
India 
Phone  09611835828  
Fax    
Email  nisarga_vhp@yahoo.com  
 
Source of Monetary or Material Support  
KAHERs KL VK Institute of Dental Sciences, JNMC Campus, Nehru nagar, Belagavi-590010, Karnataka, India 
 
Primary Sponsor  
Name  Dr Vidyavathi H Patil 
Address  Dept. of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences,JNMC Campu, Nehru nagar, Belagavi. 
Type of Sponsor  Other [Self sponsored] 
 
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 VidyavathI H Patil  KAHERs KLE VK Institute of Dental Sciences   Room No. 6, Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences, JNMC Campus Nehru nagar Belagavi -590010
Belgaum
KARNATAKA 
9611835828

nisarga_vhp@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL RESEARCH AND ETHICS COMMITTEE KLE VKIDS  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  Reframing  Reframing technique (six steps of reframing to bring change from first order to second order by content reframing) will be used as behaviour guidance technique; that is, Identify the behavior to be changed, Establish communication to know the behavior, Separate the behavior with positive intension, Access a creative part, and generate new behaviors to accomplish the positive function, Willing to take responsibility and Ecological check.The required dental treatment will then be provided for children undergoing dental treatment without and with local anesthesia 
Comparator Agent  Tell Show Do  A brief, age-appropriate description of the care to be completed will be explained to the child followed by Demonstration of the care to be completed/ equipment to be used and lastly Carrying out the care required with minimal delay for children undergoing dental treatment without and with local anesthesia 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children reporting for dental treatment for the first time.
Children between the age group of 6-12 years.
Children requiring dental procedures without and with administration of local anesthesia.
 
 
ExclusionCriteria 
Details  • Patients with past dental experience.
Patients with special health care needs.
Patients who were definitely negative as per Frankel behaviour rating scale .
Patients who were not willing to participate in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in anxiety level  At the beginning and end of the treatment procedure.  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   25/09/2024 
Date of Study Completion (India) 24/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
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 - NO
Brief Summary  

Dental anxiety is defined as a nonspecific feeling of apprehension, worry, uneasiness or dread, the source of which may be vague or unknown. It accounts to 5 to 33 percent worldwide among children. It is the primary emotions seen in a child while entering the dental operatory. Hence it is a matter of concern both to parents and dentist as and is challenging for effective treatment since it can potentially thwart child from seeking dental care. Stimuli such as strange environment, sound, sight and sensation of airotor, bright light seen in dental operatory can easily arose dental anxiety. To render high quality and successful treatment cooperation of the child plays an important role. Hence it is important to mold the child’s attitude towards pediatric dentistry and dental outcomes.

Various behavior guidance techniques are available both pharmacological and non-pharmacological to reduce anxiety in a child. However, many parents prefer non-pharmacological techniques as they regard aversive and pharmacological techniques objectionable for the behavior guidance of children in dental office. The non-pharmacological behavior guidance techniques are the corner stone of successes in pediatric dentistry as they help in coping skills, assist to develop appropriate behaviour, alleviates fear and anxiety there by building trust with the dentist and dental team.

Tell-Show-Do (TSD) is the linchpin in behavior guidance and education for children which involves a brief, age-appropriate description of the care to be completed (Tell), demonstration of the care to be completed or equipment to be used (Show) and carrying out the care required with minimal delay (Do). The orderly rational way of thinking as in TSD may lead to differing of what is expected from child where in the solution of telling may become a problem. However, the dentist can create a different reality by changing the frame of the content, which in turn changes the behavior and response of a person. This can be done through reframing.  Reframing is defined as taking a situation outside the frame that up to that moment contained the individual in different conditions and visualize (reframe) it in a way acceptable to the person involved and with this reframing both the original threat and threatened solution can be safely abandoned. Also many fields have used reframing, like therapy, education, marketing and sales. In medical literature reframing is commonly used both by the caregiver as well as by the patient for coping with stressful situations. The literature search revealed that there are no randomised clinical trials done with this reframing technique in pediatric dentistry. Hence this study is aimed at evaluating Reframing and Tell-Show-Do technique in the management of anxiety among children undergoing dental treatment without and with administration of local anesthesia.

 
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