| CTRI Number |
CTRI/2025/03/082919 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of mini-clinical evaluation exercise as a method for teaching learning method and assessment tool in postgraduate anaesthesia education |
|
Scientific Title of Study
|
Evaluation of mini-Clinical Evaluation Exercise (mini-CEX) as a teaching learning method and assessment tool in anaesthesia postgraduate education |
| Trial Acronym |
mini-CEX |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shikha Soni |
| Designation |
Associate Professor |
| Affiliation |
Dr S N Medical College, Jodhpur |
| Address |
Dept of Anaesthesia, Mahatma Gandhi Hospital, Jalori Gate, Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9950198704 |
| Fax |
|
| Email |
shikhasoni.19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shikha Soni |
| Designation |
Associate Professor |
| Affiliation |
Dr S N Medical College, Jodhpur |
| Address |
Dept of Anaesthesia, Mahatma Gandhi Hospital, Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9950198704 |
| Fax |
|
| Email |
shikhasoni.19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shikha Soni |
| Designation |
Associate Professor |
| Affiliation |
Dr S N Medical College, Jodhpur |
| Address |
Dept of Anaesthesia, Mahatma Gandhi Hospital, Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9950198704 |
| Fax |
|
| Email |
shikhasoni.19@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr S N Medical College |
| Address |
Shastri Nagar, Jodhpur, Rajasthan, India Pin- 342003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shiklha Soni |
Dr S N Medical College |
Dept of Anaesthesia, first floor Main Building, Mahatma Gandhi Hospital, Jodhpur, Rajasthan, India 342003
Jodhpur
RAJASTHAN |
09950198704
shikhasoni.19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SNMC Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
fit
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mini-CEX |
1) The concept of mini-CEX will be explained to the faculty members and the systematic ways and methods of giving feedback were conveyed to them.
2) All anaesthesia residents who consented will be sensitized toward mini-CEX.
3) A feedback questionnaire for students and faculty will be prepared, and the peer group will validate it.
4) Five encounter of mini-CEX will be conducted for each resident in different settings of the pre-anaesthetic check-up, intensive care unit, pain clinic and emergency ward with an emphasis on maintaining diversity in the clinical cases. Each student will have two encounters in each month.The duration of each encounter varies with the procedure (from 2mins to 10 mins)
5) The students will be assessed using standard mini-CEX Performa testing 7 core clinical skills rated on a 9-point scale. A score of 1–3 will be considered unsatisfactory, a score of 4–6 was considered satisfactory, and a score of 7–9 was considered superior
6) Immediate feedback will be provided to the students by the faculty as a part of formative assessment.
7) Duration of each mini-CEX will be recorded.
8) At the conclusion, the opinion of residents and faculty members regarding their experience with mini-CEX will be taken using a pre-validated questionnaire.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
faculty and residents of Department of Anaesthesia |
|
| ExclusionCriteria |
| Details |
Residents on district residency posting.
Faculty and Residents who are not willing to be a part of the study
Faculty and Residents on long leave |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objectives will be to evaluate the role of mini-CEX as an assessment/learning tool in Anaesthesiology and Critical Care of APGS and faculty members. The secondary objectives will be to assess the improvement in scores over using for 3 months and to introduce, sensitise, and train our faculty and PGS in the use of mini-CEX. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objectives will be to assess the improvement in scores over using for 3 months and to introduce, sensitise, and train our faculty and PGS in the use of mini-CEX. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/04/2025 |
| 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="3"
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
|
Workplace based assessment (WPBA) in a competency-based curriculum is the pillar for skill assessment and a few tools can be used as teaching and learning methods (TLM). Mini-clinical evaluation exercise (mini-CEX) is one method of formative assessment and WPBA. Mini-CEX is a 10-20mins clinical encounter in which a faculty member observes the trainee with the patient at the workplace, observes their history taking, examination and counselling skills and provides feedback to them. the study will be conducted on the anaesthesia postgraduate students in to evaluate mini-CEX as a method for TLM and assessment tool in anaesthesia PG education |