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CTRI Number  CTRI/2024/01/061379 [Registered on: 11/01/2024] Trial Registered Prospectively
Last Modified On: 09/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Placebo Controlled Trial 
Public Title of Study   A study on patient satisfaction after anaesthesia and interventions to improve satisfaction in a Tertiary care Hospital. 
Scientific Title of Study   A Quality Improvement Project for Patient Satisfaction after Anaesthesia at a Tertiary Care Hospital  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gincy Ann Lukachan 
Designation  Associate Professor  
Affiliation  Believers Church Medical Hospital 
Address  Department of Anaesthesiology Believers Church Medical College Hospital Thiruvalla

Pathanamthitta
KERALA
689103
India 
Phone  9447475818  
Fax    
Email  gincy.luk@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gincy Ann Lukachan 
Designation  Associate Professor  
Affiliation  Believers Church Medical Hospital 
Address  Department of Anaesthesiology Believers Church Medical College Hospital Thiruvalla

Pathanamthitta
KERALA
689103
India 
Phone  9447475818  
Fax    
Email  gincy.luk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gincy Ann Lukachan 
Designation  Associate Professor  
Affiliation  Believers Church Medical Hospital 
Address  Department of Anaesthesiology Believers Church Medical College Hospital Thiruvalla

Pathanamthitta
KERALA
689103
India 
Phone  9447475818  
Fax    
Email  gincy.luk@gmail.com  
 
Source of Monetary or Material Support  
Believers Church Medical College Hospital, Kuttapuzha, Thiruvalla, Kerala 689103 
 
Primary Sponsor  
Name  Believers Church Medical College Hospital 
Address  St Thomas Nagar Kuttapuzha Thiruvalla- 689103 
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 Gincy Ann Lukachan  Believers Church Medical College Hospital   Department of Anaesthesia St Thomas Nagar Kuttapuzha P.O. Thiruvalla
Pathanamthitta
KERALA 
9447475818

gincy.luk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Believers Church Medical College Hospital, Thiruvalla  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Quality Improvement Interventions for Postoperative pain and thirst  The interventions will be done over a period of one month. The satisfaction survey will be repeated after this period for another month. 1. Reducing the preoperative fasting periods by asking patients to drink 200 ml of water at 6 am. 2. Encouraging patients to use ice chips in the postoperative period. 3. Six hourly assessment of pain using VAS pain scores on the first post-operative day and appropriate management by the concerned anaesthesiologist if VAS scores more than 4. 4. Setting up of acute pain services to follow up patients undergoing major surgeries. 5. Educational intervention in the form of lectures, bedside discussions and visual reminders (posters, computer screensavers) in the postoperative bay. 
Comparator Agent  Regular care  Patients in this arm will receive regular care as is standard in the institution during non cardiac surgeries and their satisfaction will be measured during postoperative day 1. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All adult patients undergoing elective, inpatient non-cardiac surgeries, ASA I-III, expected post-operative duration of stay > 24 hours.
 
 
ExclusionCriteria 
Details  Patients shifted post-operatively to ICU and HDU, discharged on the same day, delirious, repeat surgery 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To investigate the areas of dissatisfaction & anaesthesia related discomfort among patients undergoing elective non-cardiac surgeries
2. To study the efficacy of a multimodal intervention strategy to improve patient satisfaction for two topmost reasons for dissatisfaction, namely postoperative pain & thirst.
 
Baseline satisfaction survey 2 months
Intervention for pain & thirst 2 months
Postintervention satisfaction survey 2 months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess risk factors for dissatisfaction among patients undergoing elective non-cardiac surgeries  Baseline satisfaction survey 2 months
Intervention for pain & thirst 2 months
Postintervention satisfaction survey 2 months 
 
Target Sample Size   Total Sample Size="800"
Sample Size from India="800" 
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)   15/01/2024 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 - Proposals should be directed to [gincy.luk@gmail.com].

  6. For how long will this data be available start date provided 15-02-2024 and end date provided 16-07-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Over the last few years, patient satisfaction has gained importance as a meaningful and essential source of information for identifying gaps in healthcare and bringing about changes, to improve the quality of care administered in hospitals. Anaesthetists are actively involved in providing peri-operative care to patients undergoing surgery. Factors which have been reported to affect patient satisfaction concerning anaesthesia services are; interaction between patient and anaesthetist, peri-operative anaesthetic management and postoperative follow-up.

We conducted a pilot study on 110 patients to assess their satisfaction with the anaesthetic services in our hospital. Patients were administered a 12-point Bauer satisfaction questionnaire (both in English and Malayalam) by a trained junior doctor on their first postoperative day. We found thirst (12/110, 11%) and pain at the surgical site (10/110, 9%) were the most common anaesthesia-related discomfort.

We plan to take include a larger cohort as the Control arm to assess satisfaction.

Following this, we plan to start interventions targeting postoperative thirst and pain as follows for one month. This includes:

1.     Reducing the preoperative fasting periods by asking patients to drink 200 ml of water at 6 am.

2.     Encouraging patients to use ice chips in the postoperative period.

3.     Six hourly assessments of pain using VAS pain scores on the first postoperative day and appropriate management by the concerned anaesthesiologist if VAS scores more than 4.

4.     Setting up of acute pain services to follow up patients undergoing major surgeries.

5.      Educational intervention in the form of lectures, bedside discussions and visual reminders (posters, computer screensavers) in the postoperative bay.

Once this intervention is in place, we will do a re-audit to evaluate satisfaction.

  Rationale
 
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