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
|
|
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
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [gincy.luk@gmail.com].
- 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.
- 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 |