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CTRI Number  CTRI/2020/02/023114 [Registered on: 04/02/2020] Trial Registered Prospectively
Last Modified On: 03/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Acceptance of Anaesthesia mask in children 
Scientific Title of Study   Comparison of Anaesthesia mask acceptance scores in children exposed to and not exposed to anaesthesia mask pre operatively during inhalational induction of anaesthesia- a prospective randomised trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Samuel David Chandran 
Designation  PG Registrar  
Affiliation  Christian Medical College and Hospital  
Address  Department of Anaesthesia Christian Medical College and Hospital Ida Scudder Road Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9789497797  
Fax    
Email  samchandran19889@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Aparna Williams 
Designation  Professor  
Affiliation  Christian Medical College and Hospital  
Address  Department of Anaesthesia Christian Medical College and Hospital Ida Scudder Road Vellore

Vellore
TAMIL NADU
632004
India 
Phone  8098899339  
Fax    
Email  williamsaparna@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Samuel David Chandran 
Designation  PG Registrar  
Affiliation  Christian Medical College and Hospital  
Address  Department of Anaesthesia Christian Medical College and Hospital Ida Scudder Road Vellore


TAMIL NADU
632004
India 
Phone  9789497797  
Fax    
Email  samchandran19889@yahoo.co.in  
 
Source of Monetary or Material Support  
Christian Medical College and Hospital Ida scudder Road Vellore 632004 Tamil Nadu 
 
Primary Sponsor  
Name  Institutional Review board Fluid grant 
Address  Institutional Review Board Christian Medical College Vellore - 632002  
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 
Samuel David Chandran  Christian Medical College and Hospital   Paediatric surgeries in CB theater complex Mother and child building
Vellore
TAMIL NADU 
9789497797

samchandran19889@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Christian Medical College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K319||Disease of stomach and duodenum, unspecified, (2) ICD-10 Condition: L949||Localized connective tissue disorder, unspecified, (3) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, (4) ICD-10 Condition: M798||Other specified soft tissue disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Anaesthesia mask   Anaesthesia mask will given to the child to play with on the previous night of surgery 
Comparator Agent  Nil  The child will not be given an anaesthesia mask. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  Children belonging to ASA physical status
1, 2, 3 posted for elective surgical procedure. 
 
ExclusionCriteria 
Details  Children with intravenous cannula in situ, history of seizures, developmental delay, ASA physical status 4 and 5 and emergency procedures.  
 
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 
Ease of Anaesthesia mask acceptance as indicated by the anaesthesia mask acceptance score  during gas induction of anaesthesia in the induction room. 
 
Secondary Outcome  
Outcome  TimePoints 
Pre operative and pre induction anxiety levels in children using Yale paediatric anxiety scale  At the holding bay and during gas induction of anaesthesia in the induction room. 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   05/02/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
Undergoing surgery is a stressful period for any child. Children undergoing surgery are bound to be anxious due to unfamiliarity of  the surroundings. One method to reduce anxiety is to pre medicate the child with certain medication, but this exposes the child to the adverse effects of these medicines and may prolong the duration of recovery. This is where the concept of non pharmacological methods to reduce pre operative anxiety comes In to the picture. Various non pharmacological methods which have been used earlier to decrease anxiety in children include parental presence at the time of induction. The aim is to make the child more acquainted with the surroundings or equipment used during anaesthesia induction. Hence the aim.of the study is to assess if pre operative exposure of children to the anaesthesia mask will improve their mask acceptance. We will also study whether this intervention reduces the anxiety during inhalational induction in this study population.
 
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