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CTRI Number  CTRI/2024/03/063559 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 29/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessment of Knowledge and fear about anaesthesia among pregnant females attending antenatal visits and to evaluate their post cesarean section feedback about anaesthesia - a cross sectional study 
Scientific Title of Study   Assessment of Knowledge, apprehension about anaesthesia and post operative satisfaction among parturients undergoing Cesarean section in a healthcare centre in south India a cross sectional 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  MERLIN SHYLA 
Designation  PhD scholar 
Affiliation   
Address  DEPARMENT OF ANAESTHESIA OPERATION THEATRE 2nd FLOOR D BLOCK CHETTINAD HEALTH CITY KELAMBAKKAM

Chennai
TAMIL NADU
603103
India 
Phone  9597561657  
Fax    
Email  merlindshyla@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun Kumar 
Designation  Professor Department of Anaesthesia 
Affiliation   
Address  OPERATION THEATRE 2nd FLOOR D BLOCK CHETTINAD HEALTH CITY KELAMBAKKAM

Chennai
TAMIL NADU
603103
India 
Phone  9489404818  
Fax    
Email  pugalenthi08@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Arun Kumar 
Designation  Professor Department of Anaesthesia 
Affiliation   
Address  OPERATION THEATRE 2nd FLOOR D BLOCK CHETTINAD HEALTH CITY KELAMBAKKAM

Chennai
TAMIL NADU
603103
India 
Phone  9489404818  
Fax    
Email  pugalenthi08@yahoo.co.in  
 
Source of Monetary or Material Support  
Hospital 
 
Primary Sponsor  
Name  Chettinad hospital and research institution 
Address  Chettinad health city rajiv gandhi salai kelambakkam tamilnadu 
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 
merlin shyla  CSI KNAYAKUMARI MEDICAL MISSION HOSPITALS  OBG DEPARTMENT OPD BLOCK CSI MISSION HOSPITAL NAGERCOIL
Kanniyakumari
TAMIL NADU 		 9597561657

merlindshyla@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee for faculty research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Participants: Parturients undergoing Cesarean section
Language: Participants who can understand and communicate in Tamil or English
Patients with ASA 1&2
 
 
ExclusionCriteria 
Details  Participants who are not willing to take part in the study
Participants with severe cognitive impairments or mental health conditions that may hinder their ability to comprehend the study objectives and provide reliable responses.
Participants with underlying medical conditions (ASA 3&4) that may affect their perception of anesthesia or post-operative satisfaction (e.g., neurological disorders, severe pain disorders).
Participants who decline or are unable to provide informed consent for participating in the study.
Participants with conditions that make it unsuitable for them to be involved in the study, such as severe complications during surgery or any conditions that could hinder their participation or responses
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the level of knowledge and apprehension about different anaesthesia techniques utilised among parturients.  preoperatively during antenatal visit 
 
Secondary Outcome  
Outcome  TimePoints 
To assess postoperative satisfaction of parturients in terms of anesthesia and the entire surgical experience who have undergone cesarean section
To determine the factors contributing to the apprehension or anxiety, and postoperative satisfaction levels among parturients undergoing Cesarean section.
 		 post operatively after LSCS  
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   30/03/2024 
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 Yet Recruiting 
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 - 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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [merlindshyla@yahoo.co.in].

  6. For how long will this data be available start date provided 30-03-2026 and end date provided 30-03-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The level of knowledge perceptions and attitude about anaesthesia among patients undergoing cesarean section will be evaluated during the antenatal visits.post operatively patients will be assessed for satisfaction lscales. 
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