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CTRI Number  CTRI/2024/03/063935 [Registered on: 11/03/2024] Trial Registered Prospectively
Last Modified On: 10/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Quantitative observational study 
Study Design  Single Arm Study 
Public Title of Study   Study to assess the level of satisfaction of patients coming to Pre anaesthesia OPD clinic 
Scientific Title of Study   A prospective observational project on assessing the satisfaction of patients visiting PAC(Pre-Anaesthetic Clinic) and the factors affecting the satisfaction score in tertiary care institute at South India.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MINU N RAJAN 
Designation  PG RESIDENT ANAESTHESIA 
Affiliation  CMC VELLORE TAMILNADU 
Address  DEPARTMENT OF ANAESTHESIA CMC VELLORE PIN CODE 632004 TAMILNADU

Vellore
TAMIL NADU
632004
India 
Phone  9400634782  
Fax    
Email  minunrajan1994@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR EKTA RAI 
Designation  HEAD OF DEPARTMENT ANAESTHESIA 
Affiliation  CMC VELLORE TAMILNADU 
Address  DEPARTMENT OF ANAESTHESIA CMC VELLORE PIN CODE 632004 TAMIL NADU

Vellore
TAMIL NADU
632004
India 
Phone  9789250113  
Fax    
Email  drektarai@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  MINU N RAJAN 
Designation  PG RESIDENT ANAESTHESIA 
Affiliation  CMC VELLORE TAMILNADU 
Address  DEPARTMENT OF ANAESTHESIA CMC VELLORE PIN CODE 632004

Vellore
TAMIL NADU
632004
India 
Phone  9400634782  
Fax    
Email  minunrajan1994@gmail.com  
 
Source of Monetary or Material Support  
Internal Fluid research grant HOSPITAL- CMC VELLORE,TAMILNADU 
 
Primary Sponsor  
Name  Internal Fluid Research Grant CMC VELLORE 
Address  CHRISTIAN MEDICAL COLLEGE VELLORE VELLORE TAMIL NADU 632004 
Type of Sponsor  Private medical college 
 
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 Minu N Rajan  Christian Medical College  CMC VELLORE DEPARTMENT OF ANAESTHESIOLOGY
Vellore
TAMIL NADU 
9400634782

minunrajan1994@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board and Ethics Committee of CMC Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z048||Encounter for examination and observation for other specified reasons,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients visiting PAC more than 18 years and less than 80 years posted for elective surgeries 
 
ExclusionCriteria 
Details  1.Patients with age group less than 18 years
2.Refusal to participate in study
3.Unable to answer questions due to poor medical condition
4.Psychaitric and mentally retarded patients
5.In patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to determine level of patients satisfaction with pre-operative anaesthetic visit  Same day 
 
Secondary Outcome  
Outcome  TimePoints 
to study about factors affecting satisfaction scores
time delay at PAC(Pre anaesthetic clinic) & understanding of PAC Consent 
one week 
 
Target Sample Size   Total Sample Size="576"
Sample Size from India="576" 
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)   25/03/2024 
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 - NO
Brief Summary  

Background: Patient satisfaction is an important measure of quality of health care and it is considered to be an integral part of service quality also. Anaesthetist plays an important role in perioperative management of a surgical patient at various stages from first visit at PAC clinic to discharge of the patient. There are lot of evidence that in-person assessment at PAC clinic is associated with reduction in morbidity and mortality. Aim of the PAC is not just to clear the patients for surgery, rather to prepare them for it by explaining about the need for optimisation of comorbidities, explaining analgesic plans ,ensuring lesser anxiety,better co-operation and improved satisfaction. But all these are lesser evaluated in our hospitals.In this background we decided to do an observational study on to assess  satisfaction of patients attending anaesthesia OPDs(PAC).

      

                      

Primary Objective: Aim of the study is to determine the level of patientÂ’s satisfaction with pre operative anaesthetic visit

 Secondary Objective: To study about the factors affecting satisfaction scores ,time delay at PAC, & understanding of PAC consent

                  

      Study design:   observational study

      Study population: Patients posted for elective surgeries in the age group of 18-80 years visiting PAC Clinic as an out patient.

      Location:  Pre anaesthetic clinic (PAC) , Christian Medical College and Hospital, Vellore.

    

 

 Methodology:

                  This study will be conducted after institutional IRB clearance. Study will be conducted on 570 patients in the age group of 18-80 years whom are posted for elective surgeries visiting PAC Clinic as an out patient. Patients will be approached by primary investigator prior to surgery in the PAC clinic (pre anaesthetic clinic) in CMC vellore. Informed consent will be taken from the patient. After obtaining a written informed consent patients were given the questionnaire in English/ Tamil/Malayalam/Hindi/Bangla(Patient survey) . We planned to conduct face to face interviews with a sample of 25 patients to validate the questionnaire for our Indian population.

 The questionnaire will be given to 20 professionals (Professional survey) including 5 Consultants in Dept. of Anaesthesia ,5 Senior residents,  1 MRO and 3 nurses who work at the PAC .

We are planning to take PEPAC questionnaire  (Patient Experiences with the Preoperative Assessment Clinic) as our starting point.PEPAC Questionnaire is a reliable, comprehensive and validated questionnaire to measure patient experiences with PAC clinic .It can be used to determine the service level of PAC in a single institute as well as to compare service levels across institutions also.Since this questionnaire has originated in UK ,hence  we are validating the language and appropriateness of content for Indian setup before starting the study.

 
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