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CTRI Number  CTRI/2024/06/068296 [Registered on: 04/06/2024] Trial Registered Prospectively
Last Modified On: 30/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate and compare three behaviour modification techniques for children of 4-9years of age for dental treatments that requires local anesthesia application 
Scientific Title of Study   Comparative evaluation of the effectiveness of three different non-pharmacological behaviour guidance techniques during dental procedures requiring local anaesthesia in 4–9-year-old children : A randomized control trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Maneesha Babu 
Designation  Principal Investigator 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  Department of Dentistry C block Ground floor All India Institute of Medical Sciences Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  08129528557  
Fax    
Email  drmaneesha242@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Virat Galhotra 
Designation  Head of the Department 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  Department of dentistry,C-block,Ground floor, AIIMS Raipur. Chhattisgarh

Raipur
CHHATTISGARH
492099
India 
Phone  9216274600  
Fax    
Email  drviratgalhotra@aiimsraipur.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Virat Galhotra 
Designation  Head of the Department 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  Department of Dentistry,C-Block,Ground floor, AIIMS Raipur. Chhattisgarh

Raipur
CHHATTISGARH
492099
India 
Phone  9216274600  
Fax    
Email  drviratgalhotra@aiimsraipur.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Tatibandh , Raipur, Chhattisgarh , India pincode 492099 
 
Primary Sponsor  
Name  All India Institute of Medical SciencesRaipur 
Address  All India Institute of Medical Sciences, G E Road, Tatibandh Raipur Chhattisgarh India pincode 492099 
Type of Sponsor  Research institution and hospital 
 
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 Maneesha Babu  All India Institute of Medical Sciences,Raipur  Department of Dentistry,C-Block,Ground floor, Gate no 4, AIIMS RAIPUR, G E Road,Tatibandh 492099
Raipur
CHHATTISGARH 
8129528557

drmaneesha242@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of Ethics Committee, AIIMS Raipur  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  comparison of Non-pharmacological behaviour management techniques  The behaviour management techniques namely Tell-show-do, Tell-show-play-doh with teach back and filmed modelling will be applied on children before the dental treatment and compared based on reduction in anxiety and improvement in co-operativeness that will be assessed using changes in heart rate sp02 and scales such as facial image scale and frankels behaviour rating scale. duration of intervention : 18months 
Comparator Agent  comparison of Non-pharmacological behaviour management techniques  the techniques tell show do, tell play doh with teach back and filmed modelling will be compared with each other 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Children between age group of 4 to 9 years
Children with Frankl’s behavior rating score of 2 or 3
Children coming for first dental visit / 6 months elapsed between current and previous dental visit.
Children with a treatment need that requires the administration of local anesthesia
Children whose parent/legal guardian give consent to participate in the study 
 
ExclusionCriteria 
Details  Children with Frankl’s behavior rating score of 1 or 4
Children below 4 years of age and above 9 years of age
Children with systemic,neurological,coagulopathy, psychiatric or behavioral conditions, which precludes the ability to display suitable behavior
Children coming for treatment modalities not requiring local anesthesia.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in anxiety accessed using change in heart rate and sp02   baseline-pretreatment
during treatment
post treatment 
 
Secondary Outcome  
Outcome  TimePoints 
improvement in cooperativess of child assessed using frankels behaviour rating scale  baseline-pretreatment
during treatment
post treatment 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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 2/ Phase 3 
Date of First Enrollment (India)   17/06/2024 
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="1"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drmaneesha242@gmail.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 04-01-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

        The phenomena of dental fear and anxiety in children is a pervasive and often underestimated issue that has significant implications for both the oral health of young individuals and their overall well-being. Children may experience various levels of apprehension due to dental treatment, which may be mild and temporary, or severe and protracted, and may develop even before the scheduled visit. The amount of information that is perceived by a child depends on the cognitive development of the child.

The "Tell-Show-Do (TSD)" communication model, is regarded as the foundation of behavior control strategies. Its goal is to reduce the child’s fear by acquainting them with the dental environment. A modified version of this technique is tell-show-play doh, which makes use of the principle of learning by doing.

 Learning through observation is known as modeling, and it can occur when children mimic a model’s actions in a similar circumstance. Modelling can be live modelling or filmed modelling. Research has shown that modeling can help children learn better coping mechanisms for stressful medical situations and can be a therapeutic tool for managing anxiety.

Teach back is a verbal communication strategy, is an efficient way to reinforce or provide health education to both adults and children. Combining Tell-Show-Play-Doh and teach back techniques is expected to provide the child a clear understanding of what he/she is going to be experience, and can help prepare the child for the treatment by alleviating the associated anxiety.

 

JUSTIFICATION OF THE STUDY   Only limited studies are available comparing Tell-show-Play-Doh and Filmed modelling. Also, no such studies have been done combining teach back technique with Tell-Show-Play-Doh. Moreover, most of the studies have been done during preventive treatment procedure. Hence this study will be undertaken during procedures which require local anesthesia administration, for assessment of the reduction in anxiety and improvement in cooperativeness of behavior after applying the behavior modification technique

 

 
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