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CTRI Number  CTRI/2023/01/048689 [Registered on: 03/01/2023] Trial Registered Prospectively
Last Modified On: 27/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Anxiety reduction with breathing exercises for dental anaesthesia administration 
Scientific Title of Study   Comparative evaluation of two relaxation breathing exercises for anxiety reduction in children receiving local anaesthesia-a randomized clinical study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanika Umesh Karmarkar 
Designation  Post graduate student 
Affiliation  KLE VK Institute of dental sciences, Belgaum 
Address  JNMC campus, Nehru nagar,
Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India 
Phone  9920896106  
Fax  -  
Email  sanikakarmarkar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chandrashekhar Badakar 
Designation  Reader, Department of pediatric and preventive dentistry 
Affiliation  KLE VK Institute of dental sciences, Belgaum 
Address  JNMC campus, Nehru nagar,
Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India 
Phone  9902773259  
Fax  -  
Email  badakar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sanika Umesh Karmarkar 
Designation  Post graduate student 
Affiliation  KLE VK Institute of dental sciences, Belgaum 
Address  JNMC campus, Nehru nagar,
Belgaum, Karnataka
Belgaum
KARNATAKA
590010
India 
Phone  9920896106  
Fax  -  
Email  sanikakarmarkar@gmail.com  
 
Source of Monetary or Material Support  
Department of pediatric and preventive dentistry, KLE VK Institute of dental sciences 
 
Primary Sponsor  
Name  Sanika Karmarkar 
Address  KLE VK INSTITUTE OF DENTAL SCIENCES, BELAGAVI, KARNATAKA 
Type of Sponsor  Other [Self funded] 
 
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 
Sanika Karmarkar  KLE VK Institute of dental sciences  Department of pediatric and preventive dentistry, KLE VK Institute of dental sciences, JNMC campus, Nehru nagar, Belgaum, Karnataka
Belgaum
KARNATAKA 		 9920896106

sanikakarmarkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLE VK Institute of dental sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients requiring local anaesthesia for dental procedures 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Breathing exercises  Breathing exercises using pinwheel and bubble blowing for anxiety reduction Performed for 3-5 minutes, 1 time 
Comparator Agent  Pinwheel breathing exercise, bubble blowing breathing exercise  Anxiety reduction seen after performing the breathing exercises compared with patients who dont perform breathing exercises before receivinglocal anaesthesia 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children between the ages of 6 to 12 years
Children requiring dental treatment under local anaesthesia.
No history of allergy to anaesthetic drugs
Children with no previous exposure to dental treatment 
 
ExclusionCriteria 
Details  Children with special healthcare needs.
Children with medical conditions contraindicating the use of local anesthetics
containing adrenaline.
Children with respiratory disorders
Children whose parents don’t consent to the breathing exercise procedure.
• Soft-tissue infection/inflammation near the area of injection. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Anxiety reduction  baseline, 10 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/01/2023 
Date of Study Completion (India) 13/02/2023 
Date of First Enrollment (Global)  06/01/2023 
Date of Study Completion (Global) 13/02/2023 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   - 
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
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 26-08-2022 and end date provided 26-02-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 Children undergoing dental treatment are usually anxious about receiving local anaesthesia. The sight and feeling of the anesthetic needle have been identified as the most fear-eliciting stimuli. Therefore, behavior guidance is a core aspect of pediatric dental practice.

In order to reduce procedural pain and anxiety, cognitive behavioural techniques like distraction, relaxation strategies and coping mechanisms have been widely studied and used. Another therapy that has been used by psychologists to communicate with and manage child behaviour has been the ‘play therapy’. It involves providing objects or situations in the form of games, and thereby establishing communication and relaxation of the child.
In this study, a pinwheel and bubble blower will be used as play therapy while teaching the child rhythmic deep breathing as they blow on the pinwheel to rotate it and blow the bubbles. The child will be asked to breathe in the learnt pattern as he/she receives the local anaesthesia.

The study intends to find out the relaxation and anxiety reduction brought about by deep breathing while using the play therapy.

Methodology:
Pre operative anxiety measurement will be done with pulse rate reading and score on the Venham’s Picture test before the local anaesthesia is administered. 
The children will be allocated to 3 groups using lottery method, namely, Group A (Control; no breathing exercise performed), Group B ( pinwheel exercise performed) and Group C ( bubble blowing exercise performed).
The children belonging to Group B and C will be given demonstrations for the exercises and then asked to perform those till their satisfaction.
Following that, local anesthetic gel will be applied and local  anesthesia will be injected for the concerned treatment and tooth/ teeth.
Post operative anxiety will be checked after the local anaesthesia administration is complete with pulse rate reading and score on Venham’s picture test.
 
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