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CTRI Number  CTRI/2025/02/080471 [Registered on: 13/02/2025] Trial Registered Prospectively
Last Modified On: 10/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Breathing exercise]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   effect of a breathing exercise on anxiety of patients 
Scientific Title of Study   the effect of box breathing exercise on anxiety during administration of buccal infiltration in children aged 6 to 10 years. 
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 Harsha Kewlani 
Designation  Part 3 Post gruduate student 
Affiliation  College of Dental sciences and research centre, Bopal 
Address  College of dental sciences and research centre Near navneet printing press, opposite pleasure club, bopal, ahmedabad Ahmadabad GUJARAT

Ahmadabad
GUJARAT
382115
India 
Phone  09023999594  
Fax    
Email  harshakewlani28@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harsha Kewlani 
Designation  Part 3 Post gruduate student 
Affiliation  College of Dental sciences and research centre, Bopal 
Address  College of dental sciences and research centre Near navneet printing press, opposite pleasure club, bopal, ahmedabad Ahmadabad GUJARAT


GUJARAT
382115
India 
Phone  09023999594  
Fax    
Email  harshakewlani28@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Harsha Kewlani 
Designation  Part 3 Post gruduate student 
Affiliation  College of Dental sciences and research centre, Bopal 
Address  College of dental sciences and research centre Near navneet printing press, opposite pleasure club, bopal, ahmedabad Ahmadabad GUJARAT


GUJARAT
382115
India 
Phone  09023999594  
Fax    
Email  harshakewlani28@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Self College of dental sciences and research centre 
Address  Silver alaknanda dental college road, nr navneet printing press, manipur,ahmedabad 
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 Harsha Kewlani  College of dental sciences and research centre  2nd floor department of pediatric and preventive dentistry,CDSRC,Near navneet printing press, opposite pleasure club, bopal, ahmedabad
Ahmadabad
GUJARAT 		 09023999594

harshakewlani28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical commitee college of dental sciences and research centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  children who have anxiety to dental treatment 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  breathing exercise  box breathing exercise, inhaling for 4 seconds, hold for 4 seconds, exhaling for 4 secongs and again hold for 4 seconds. 
Comparator Agent  without exercise  dental anxiety is assessed without introducing box breathing exercise 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  good physical health, Requiring bilateral infiltration, should be nasal breathers, show mild to moderate anxiety levels according to RMS, Frankl’s behaviour rating-2,3  
 
ExclusionCriteria 
Details  Children with severe anxiety
uncooperative behaviour or cognitive impairments that may hinder participation
mouth breathers 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Dental Anxiety
Dental Pain
 		 at baseline,immediately after box breathing exercise 
 
Secondary Outcome  
Outcome  TimePoints 
cooperation or behaviour  at baseline, immediately after box breathing exercise 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   24/02/2025 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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 procedures, especially local anesthetic administration, are a source of great anxiety to children. Breathing exercises have been proposed as an effective intervention to improve subjective well-being and manage anxiety symptoms. As they are comparatively easy to learn and to implement, breathing exercises may be particularly beneficial for children. Box breathing or square breathing involves inhaling, holding the breath, exhaling and again holding the breath for 4 counts. It forms the box pattern with the breath.

 

 

Aim:

The aim of this study is to evaluate immediate effects of Box breathing exercise on anxious children before and after administration on Buccal infiltration.

children between age range of 6-10 years who require bilateral buccal infiltration local anesthesia for dental treatment will be randomly selected.

 Inclusion Criteria:  good physical health, have no previous experience with breathing exercises for anxiety relief, should be nasal breathers and show mild to moderate anxiety levels according to RMS.

Exclusion Criteria: Children with severe anxiety, or cognitive impairments that may hinder participation, mouth breathers.

Informed Consent and Ethical Approval- taken.

The children will be administered buccal infiltration local anesthesia in the first session. After an interval period of 1 week, on the second session, the children will be taught box breathing exercise just prior to administration of buccal infiltration local anesthesia on the contralateral side.

Dental anxiety, dental pain and child’s behaviour assessed

 
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