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CTRI Number  CTRI/2025/01/079195 [Registered on: 22/01/2025] Trial Registered Prospectively
Last Modified On: 21/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Studying How Well Practical Skill Assessments Work for Training Anesthesia Students and What They Think About It 
Scientific Title of Study   A Mixed-Design Study on the Effectiveness and Perceptions of Direct Observation of Procedural Skills (DOPS) in Anaesthesiology Postgraduate Education 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shilpa J 
Designation  Associate professor 
Affiliation  St Johns Medical college hospital 
Address  Operation theatre, Dept of anaesthesiology, SJMCH, koramangala, bangalore
SJMCH, koramangala, bangalore
Bangalore
KARNATAKA
560034
India 
Phone  09986784722  
Fax    
Email  shilpa.j.rao@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shilpa J 
Designation  Associate professor 
Affiliation  St Johns medical college hospital 
Address  operation theatre, dept of anaesthesiology, SJMCH, koramangala, bangalore

Bangalore
KARNATAKA
560034
India 
Phone  09986784722  
Fax    
Email  shilpa.j.rao@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shilpa J 
Designation  Associate professor 
Affiliation  St Johns medical college hospital 
Address  operation theatre, dept of anaesthesiology, SJMCH, koramangala, bangalore

Bangalore
KARNATAKA
560034
India 
Phone  09986784722  
Fax    
Email  shilpa.j.rao@gmail.com  
 
Source of Monetary or Material Support  
operation theatre, dept of anaesthesiology, St Johns medical college hospital, koramangala, Bangalore 560034.  
 
Primary Sponsor  
Name  Shilpa J 
Address  Dept of anaesthesiology, St Johns medical college hospital, koramangala, Bangalore 560034. 
Type of Sponsor  Other [(Self)] 
 
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 Shilpa J  St Johns medical college hospital  Operation theatre, Dept of anaesthesiology.
Bangalore
KARNATAKA 
09986784722

shilpa.j.rao@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St Johns medical college, institutional ethical review board committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Improvement in procedural skills after feedback using direct observation of procedural skills(DOPS) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  not applicable 
Intervention  Work place based assessment called DOPS  All the anaesthesiology post graduates will be given feedback using Direct Observations of procedural skills and re evaluated at the end of 2weeks  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  42 anaesthesiology post graduates and DOPS trained faculty 
 
ExclusionCriteria 
Details  post graduates and faculty not consenting to participate in the study 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of Direct Observation of Procedural Skills (DOPS) in Anaesthesiology Postgraduate Education.  To evaluate the effectiveness of Direct Observation of Procedural Skills (DOPS) in Anaesthesiology Postgraduate Education at the end of DOPS session and at the end of 2weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the perceptions of Postgraduate Students and Faculty on Direct Observation of Procedural Skills (DOPS) in Anaesthesiology using a mixed-methods Interventional Study.  At the end of DOPS session and at the end of 2weeks. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   02/02/2025 
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="3"
Months="0"
Days="0" 
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  

Assessments of procedural skills within anaesthesia training programme have historically been performed through a combination of retrospective subjective feedback from supervising faculty without specific criteria, self-reported procedure logs, or both.

Formative assessments are used to aid learning and have been described as ‘assessment for learning’. In order to be useful, feedback from formative assessment needs to occur in a timely manner, so that it can influence a trainee’s progress. Traditional thinking has been that feedback should be given as soon as possible, sometimes concurrently during the performance of the procedure.

 However, there is recent evidence that feedback after completion of a task is more effective than concurrent feedback, especially for long-term retention of skills.

Formative assessment is usually undertaken during supervised clinical work and so its effectiveness is subject to attributes of the supervisor such as willingness to teach and interpersonal skills.

Our study will help us assess how the DOPS method of WPBA is going to be beneficial in our context and also the feasibility of its application in our clinical practice.

 
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