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CTRI Number  CTRI/2021/03/031954 [Registered on: 12/03/2021] Trial Registered Prospectively
Last Modified On: 23/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Studying the benefits of giving information to patients about procedures to be expected in hospitals before and after surgery in improving the patients experience through their first surgery. 
Scientific Title of Study   Effect Of Preoperative Counseling On Patients Overall Surgical Experience Through Their First Surgical Journey In A Tertiary Care Hospital :A Randomized Control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Feba Susan Kurian 
Designation  Student 
Affiliation  MOSC Medical College,Kolencherry 
Address  2017 batch MBBS student MOSC Medical College, Medical College Road, Kolenchery Ernakulam

Ernakulam
KERALA
686106
India 
Phone  9061984552  
Fax    
Email  febask1999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Santosh Balakrishnan 
Designation  Associate Professor 
Affiliation  MOSC Medical College,Kolencherry 
Address  Department of General Surgery, MOSC Medical College, Kolenchery

Ernakulam
KERALA
682311
India 
Phone  9747058458  
Fax    
Email  santosurg@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Santosh Balakrishnan 
Designation  student 
Affiliation  MOSC Medical College,Kolencherry 
Address  Associate Professor, Department of General Surgery, MOSC Medical College, Kolenchery

Ernakulam
KERALA
682311
India 
Phone  09747058458  
Fax    
Email  santosurg@yahoo.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  Feba Susan Kurian 
Address  2017 batch MBBS student, MOSC Medical College, Kolenchery 
Type of Sponsor  Other [Self sponsored trial] 
 
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 
Feba Susan Kurian  MOSC Medical College,Kolencherry  Medical College Road,PO Kolencherry, Kochi, Kerala
Kottayam
KERALA 		 919061984552

febask1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MOSC Medical college IEC  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 
Comparator Agent  Current practice   Patients are provided information as per current standard of are in the institute. 
Intervention  Pre-operative Patient education  Patients who receive pre-operative educational counselling about routine elements of peri-operative care in addition to standard hospital care 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Inpatients admitted to surgery and urology wards at the study institute.
a) Age group:18-80 years
b) Patient’s undergoing surgical procedures under general and spinal anaesthesia.
 
 
ExclusionCriteria 
Details  a) Patients undergoing major surgeries requiring post-operative intensive care other than the purpose of recovery from anaesthesia and surgery.
b) Patients undergoing minor surgeries under local anaesthesia.
c)Patients undergoing emergency surgical procedures.
d)Patients who have had previous surgical experience other than obstetric procedures
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Objective assessment of improved patient experience using validated questionnaire  We will conduct interim review of our findings in one months and then at the completion of data collection in 2 months. 
 
Secondary Outcome  
Outcome  TimePoints 
None planned for study  Not applicable 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="62" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   15/03/2021 
Date of Study Completion (India) 24/04/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Since project is part of ICMR-STS programme,publication is to be decided after completion of the project. 
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 (Others) -  De-identified data will be made available as excel sheets.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    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 (Others) -  Researchers interested in viewing data may contact us via email at febask1999@gmail.com and above defined data will be available through a secure google drive link

  6. For how long will this data be available start date provided 23-11-2021 and end date provided 31-10-2024?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary
Modification(s)  		 Preoperative counselling refers to an educational intervention before surgery which aims at improving patient’s knowledge, health and outcome. Going through surgery can be a frightening event even when the surgery is relatively minor. Preoperative counselling aims to alleviate the fears of the patients and provide psychological preparation for the treatment experience .In pre-surgical counselling ,patients are informed about the potential risks ,complications and benefits of surgery .Our study seeks to investigate whether educating patients on those aspects of peri-operative care inherent to all surgical procedures but often unaddressed have a role in improving patient’s overall surgical experience.
Our inclusion criteria is :Inpatients admitted to surgery and urology wards at the study institute.
                                     a)Age group:18-80 years
                                     b)Patient’s undergoing surgical procedures under general and spinal anaesthesia.
exclusion criteria        :a)Patients undergoing major surgeries requiring post-operative intensive care other than the purpose of recovery from anaesthesia and surgery.
                                    b)Patient’s undergoing minor surgeries under local anaesthesia.
                                    c)Patients undergoing emergency surgical procedures.
                                    d)Patients who have had previous surgical experience other than obstrectic procedures.
Our sample size is n=62 and study design is randomised control trial
 
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