CTRI Number |
CTRI/2023/08/056934 [Registered on: 25/08/2023] Trial Registered Prospectively |
Last Modified On: |
16/11/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Single Arm Study |
Public Title of Study
|
Patient Satisfaction survey of anaesthesia related issues |
Scientific Title of Study
|
A Survey to Understand Patient Satisfaction with Specific
Anaesthesia-Related Aspects of Care in A Tertiary Care Centre in 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 |
Pratibha Kane |
Designation |
HOD Anaesthesia |
Affiliation |
Jehangir hospital and Research centre |
Address |
Jehangir Hospital.
Department of Anaesthesia
32 SASSOON RD.PUNE.
411001 Department of Anaesthesia
Jehangir Hospital
32, SASSOON RD.PUNE 1
411001 Pune MAHARASHTRA 411001 India |
Phone |
9822090771 |
Fax |
|
Email |
pratibha.kane@jehangirhospital.com |
|
Details of Contact Person Scientific Query
|
Name |
PRATIBHA KANE |
Designation |
Head Of Department. Anaesthesia |
Affiliation |
Jehangir hospital and Research centre |
Address |
Department of Anaesthesia Jehangir Hospital.
32 Sassoon Rd.Pune
411001 Department of Anaesthesia
Jehangir Hospital.
32, SASSOON RD.PUNE 1
411001 Pune MAHARASHTRA 411001 India |
Phone |
9822090771 |
Fax |
|
Email |
pratibha.kane@jehangirhospital.com |
|
Details of Contact Person Public Query
|
Name |
PRATIBHA KANE |
Designation |
HOD Anaesthesia |
Affiliation |
Jehangir hospital and Research centre |
Address |
Jehangir Hospital.
Department of Anaesthesia
32, Sassoon Rd. Pune.
411001
Department of Anaesthesia
Jehangir Hospital
32,SASSOON RD.PUNE1
411001 Pune MAHARASHTRA 411001 India |
Phone |
9822090771 |
Fax |
|
Email |
pratibha.kane@jehangirhospital.com |
|
Source of Monetary or Material Support
|
PRATIBHA KANE
Head of Department. Department of Anaesthesia. Jehangir Hospital. 32 Sassoon Road. Pune 1 |
|
Primary Sponsor
|
Name |
PRATIBHA KANE |
Address |
JEHANGIR HOSPITAL |
Type of Sponsor |
Other [SELF FUNDED] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
PRATIBHA KANE |
JEHANGIR HOSPITAL |
Department of Anaesthesia. 2nd Floor. Jehangir Hospital. 32, Sassoon Road.
PUNE 1. 411001 Pune MAHARASHTRA |
9822090771
pratibha.kane@jehangirhospital.com |
PRATIBHA KANE |
JEHANGIR HOSPITAL |
Department of Anaesthesia. 2nd Floor. Jehangir Hospital 32, Sassoon Rd.
Pune 1. 411001 Pune MAHARASHTRA |
9822090771
pratibha.kane@jehangirhospital.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
JEHANGIR CLINICALDEVELOPMENT CENTRE PVT LTD |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, (2) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
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 |
All patients who have undergone surgery under General Anaesthesia |
|
ExclusionCriteria |
Details |
All patients who are sent to ICU postoperatively
All patients who refuse to take part in the survey. |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Patient Satisfaction |
QUESTIONAIRE FOR PATIENT SATISFACTION |
|
Secondary Outcome
|
Outcome |
TimePoints |
SATISFACTION SCALE |
1-10 SCALE |
|
Target Sample Size
|
Total Sample Size="1000" Sample Size from India="1000"
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)
|
19/09/2023 |
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)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
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
|
Introduction: There are multiple complex factors which affect satisfaction with anaesthesia services. In India, anaesthesia service and the importance of anaesthesia in the overall outcome of surgery is not well recognised. Most patient satisfaction studies in the postoperative period are usually about general satisfaction with hospital services. We propose to look at some important aspects of patient satisfaction about the specific anaesthesia-related indicators of awareness and postoperative discomfort of all patients undergoing General Anaesthesia in the period between 15th August to 31st December.2023. This will be done with a structured survey based on questions related mainly to aspects of awareness and post-operative discomfort in all patients who have undergone General Anaesthesia in Jehangir Hospital between 1st August 2023 to 31st December 2023. Any other data which is highlighted during the questionnaire interview will also be presented in the results as aspects of importance to the patient. This questionnaire will be presented to the patient who consents to fill out the survey form by a member of the staff who is not connected with the anaesthesia service. There are very few studies of anaesthesia-related patient satisfaction as there are multiple factors which are of extreme importance to the patient in the first 24 hours. Most people forget about the anaesthesia experience when things go right. At the same time, they are very bitter about anaesthesia/anaesthetist when complications take place. In this study, we are trying to understand issues of importance to the patient through a questionnaire. This task is difficult as most people with good experience are reluctant to comment on the details and are mostly glad it is over. Patients with a prolonged stay or developing complications are reluctant to participate in the survey. It is also difficult to separate the postoperative complications into anaesthesia and surgical complications as they overlap. This study is expected to help us improve our anaesthesia services, especially focusing on the incidence of awareness and postoperative concerns related to anaesthesia which significantly affect patient satisfaction after surgery. |