| CTRI Number |
CTRI/2024/07/069996 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
04/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the effectiveness of direct observation of procedural skills (DOPS) as a formative assessment tool in postgraduates students in Anaesthesia |
|
Scientific Title of Study
|
Evaluation of direct observation of procedural skills (DOPS) as a formative assessment tool in postgraduates students in Anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vandana Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Dr S N Medical College, Jodhpur |
| Address |
Department of Anaesthesia, Dr SN medical college, Shastri nagar, Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9460157024 |
| Fax |
|
| Email |
vandana.sh02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Dr S N Medical College, Jodhpur |
| Address |
Department of Anaesthesia, Dr SN medical college, Shastri nagar, Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9460157024 |
| Fax |
|
| Email |
vandana.sh02@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Dr S N Medical College, Jodhpur |
| Address |
Department of Anaesthesia, Dr SN medical college, Shastri nagar, Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9460157024 |
| Fax |
|
| Email |
vandana.sh02@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Vandana Sharma |
| Address |
Department of Anaesthesiology, Dr S N Medical College, Jodhpur, Rajasthan, India 342003 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Shikha Soni |
Department of Anaesthesiology, Dr S N Medical College, JOdhpur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vandana Sharma |
Mahatma Gandhi Hospital |
Department of Anaesthesia, Main OT complex, First Floor
Jodhpur
RAJASTHAN |
9460157024
vandana.sh02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee SNMC Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PG students and Faculty |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Direct observation of procedural skills (DOPS) |
Work-place based assessments (WPBA) are introduced to assess psychomotor domain of procedural skills. Direct observation of procedural skills (DOPS) is a WPBA tool designed to observe procedural skills involving real patient encounters, followed by proper immediate feedback by the evaluator to the trainee. Here, proper observation and timely feedback play important roles in improving student’s learning.
Total time taken during intervention (including both observation and feedback) can varies from 10-20 mins depending on procedure.
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Faculty members involved in the teaching
2. PG students of all three years
|
|
| ExclusionCriteria |
| Details |
1. Faculty unavailable due to long leave
2. Individuals unwilling to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the performance (likert scale) of the PG students in DOPS during formative assessment in Anaesthesia department |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To explore the perceptions of PG students & faculty about DOPS as assessment tool both quantitatively (Likerts scale) & qualitatively (open questions) |
1 month |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
15/07/2024 |
| 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="0"
Months="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is a prospective educational interventional study will be conducted with a aim to evaluate the effectiveness of DOPS as a formative assessment tool in anaesthesia PG education.The study will be conducted in the department of Anaesthesia , Dr S N Medical College, Jodhpur. The primary objective of the study is to compare the performance (likert scale) of the PG students in DOPS as formative assessment in Anaesthesia department and the secondary objective is to explore the perception of PG students and faculty about DOPS as assessment tool both quantitatively and qualitatively. |