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CTRI Number  CTRI/2024/11/077254 [Registered on: 25/11/2024] Trial Registered Prospectively
Last Modified On: 14/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Mixed method study 
Study Design  Single Arm Study 
Public Title of Study   Attitudes, perceptions and experience of parents regarding their presence at induction of anaesthesia  
Scientific Title of Study   Attitudes perceptions and experience of parents regarding their presence at induction of anaesthesia in Children A Mixed method 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  Naitham Dileep 
Designation  junior Resident 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Department of anesthesia,4th floor,Nehru hospital,Post Graduate Institute of Medical Education and Research,sector 12,chandigarh ,160012

Chandigarh
CHANDIGARH
160012
India 
Phone  7396989606  
Fax    
Email  dileepnitham@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Naveen Naik B  
Designation  Assistant professor 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Department of anesthesia,4th floor,Nehru hospital,sector 12,chandigarh ,160012

Chandigarh
CHANDIGARH
160012
India 
Phone  8872377925  
Fax    
Email  navin_amc@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Naveen Naik B 
Designation  Assistant professor 
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Department of anesthesia,4th floor,Nehru hospital,sector 12,chandigarh ,160012
Department of anesthesia,4th floor,Nehru hospital,sector 12,chandigarh ,160012
Chandigarh
CHANDIGARH
160012
India 
Phone  8872377925  
Fax    
Email  navin_amc@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive care, 4th Floor, Nehru Hospital, Block A, POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH,SECTOR 12 CHANDIGARH PINCODE 160012,INDIA 
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education and Research 
Address  Department of Anaesthesia and Intensive care, 4th floor Nehru hospital, Post Graduate Institute of Medical Education and Research, SECTOR 12, PINCODE 160012 CHANDIGARH INDIA 
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 Dileep  Post Graduate Institute of Medical Education and Research  Department of Anaesthesia and Intensive care,4th floor nehru hospital,Post graduate institute of medical education and research, Sector 12
Chandigarh
CHANDIGARH 
07396989606

dileepnitham@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Postgraduate Institute of Medical Education and Research Chandigarh Institutional Ethics Committee Intramural  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  parents who are willing to participate in study
able to communicate in english/hindi
consented to participate in study 
 
ExclusionCriteria 
Details  parents/caregivers who did not wish to participate in study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To describe the attitudes, perceptions, and experiences of parents concerning PPIA.
 
with in 24hours of post induction

 
 
Secondary Outcome  
Outcome  TimePoints 
To describe the role of the following factors in influencing these perceptions surrounding the practice of PPIA in
Profession of parent
Family income (Kuppuswamy scale)
rural/urban
Sibling order
Premedication
Type of anaesthesia (Inhalational/Intravenous induction)
 
with in 24hours of post induction
 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/12/2024 
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="0"
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 - NO
Brief Summary  

Parental presence at anaesthesia induction is defined as the interaction of the child, parent, anaesthesiologist, and peri-operative nurses in the induction room for the duration of anaesthesia induction.4 The protection of one’s offspring is a powerful parental biological instinct, and, unsurprisingly, the separation of children from their parents for medical procedures is stressful for both children and their parents.3 Most children under the age of sixteen are not sufficiently psychologically and intellectually developed to deal with the psycho-trauma associated with pre-operative fears and anxieties, which are exacerbated when they are separated from their parents.Parental presence at anaesthesia induction is defined as the interaction of the child, parent, anaesthesiologist, and peri-operative nurses in the induction room for the duration of anaesthesia induction.4 However, research exploring the attitudes, perceptions, and experiences of parents regarding this practice is limited within the Indian context, which has one of the most religiously and ethnically diverse populations. At our institute, where patients of multiple ethnic groups, speaking different languages coexist. We hypothesize that diverse beliefs will influence the experience a parent has in Operation Theatre regarding PPIA. Furthermore, the results of this study may help form policies guiding PPIA at our institution and may be relevant to other institution in oour country.in this study we will take consent of childrens parents between 2 to 8 years posted for elective surgeries.ocess of we will take parents inside along with patient they are gonna witness entire process of induction of anesthesia. we will conduct interviews of parents within 24 hours of post induction of anesthesia regarding presnce at induction of anesthesia and we willl note their experience. 

 
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