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CTRI Number  CTRI/2025/02/080559 [Registered on: 14/02/2025] Trial Registered Prospectively
Last Modified On: 12/08/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Quasi experimental study using mixed method analysis 
Study Design  Single Arm Study 
Public Title of Study   Helping first-year medical students to think creatively and solve problems better using teamwork 
Scientific Title of Study   Enhancing creative problem-solving skills among first year medical students using a Metacognition module and team-based approaches. 
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 Sundip Charmode 
Designation  Associate Professor 
Affiliation  All-India Institute of Medical Sciences Rajkot  
Address  Department of Anatomy, Ground floor, Academic block, AIIMS Rajkot, KHANDHERI, RAJKOT-360110

Rajkot
GUJARAT
360110
India 
Phone  09633239685  
Fax    
Email  sundip.charmode@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sundip Charmode 
Designation  Associate Professor 
Affiliation  All-India Institute of Medical Sciences Rajkot  
Address  Department of Anatomy, Ground floor, Academic block, AIIMS Rajkot, KHANDHERI, RAJKOT-360110

Rajkot
GUJARAT
360110
India 
Phone  09633239685  
Fax    
Email  sundip.charmode@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sundip Charmode 
Designation  Associate Professor 
Affiliation  All-India Institute of Medical Sciences Rajkot  
Address  Department of Anatomy, Ground floor, Academic block, AIIMS Rajkot, KHANDHERI, RAJKOT-360110

Rajkot
GUJARAT
360110
India 
Phone  09633239685  
Fax    
Email  sundip.charmode@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anatomy, All India Institute of Medical Sciences (AIIMS) Rajkot, Gujarat-360110 
 
Primary Sponsor  
Name  Dr Sundip Charmode 
Address  Department of Anatomy, Academic block, AIIMS Rajkot, KHANDHERI, RAJKOT-360110 
Type of Sponsor  Other [All the expenses will be paid by the principal investigator from his Learning resources allowance. ] 
 
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 Sundip Charmode  All India Institute of Medical Sciences (AIIMS) Rajkot  Department of Anatomy, Academic block, AIIMS Rajkot, KHANDHERI, RAJKOT-360110
Rajkot
GUJARAT 
09633239685

sundip.charmode@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee, AIIMS Rajkot  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal healthy human volunteers shall be selected. First year MBBS undergraduate students will be selected.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1st MBBS medical undergraduates who will give informed consent.
 
 
ExclusionCriteria 
Details  1st MBBS medical undergraduates who will not give informed consent.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Short term outcome (0-1 years):
a. Acquiring enhanced creative problem-solving skills amongst medical undergraduate students in their 1st professional year.
b.Better retention of creative problem-solving skills amongst medical undergraduate students in their 2nd professional year.
 
Milestone Targets Date
Acquiring the copyright permission for using the 52-items MAI scale, Collecting all the evaluation items, Standardizing and Validating them to construct a new metacognition measurement scale for the project. By the end of 2nd month after ethical approval. 31st December 2024
Execution of the module in the institution amongst the 1st year medical undergraduate students. By the end of 6th month after ethical approval. 31st May 2025
Qualitative and quantitative data collection, its evaluation, Compilation of data, master chart preparation, statistical analysis and final report preparation By the end of 8th months 31st July 2025
Publication of study findings. By the end of 12 months. 31st August 2025
 
 
Secondary Outcome  
Outcome  TimePoints 
2. Intermediate outcome (3-5 years):
a. Acquiring enhanced creative problem-solving skills amongst medical professionals.
b. Acquiring enhanced creative problem-solving skills amongst the non-medical professionals.



3. Long term outcome (5-7 years):
a. Reduced misdiagnoses and complications in the patients reporting to the institute.
b. Enhanced the overall patient health outcomes.
c. Enhanced patient safety and satisfaction.
d. Reduced financial burden on the patient and his/her family members.
 
Intermediate outcome (3-5 years):
Milestones
a. Acquiring enhanced creative problem-solving skills amongst medical professionals.

Time period
3rd and 4th year after the project gets completed.

Milestones
b. Acquiring enhanced creative problem-solving skills amongst the non-medical professionals.

Time period
4th and 5th year after the project gets completed.


3. Long term outcome (5-7 years):
Milestones
a. Reduced misdiagnoses and complications in the patients reporting to the institute.
b. Enhanced the overall patient health outcomes.
c. Enhanced patient safety and satisfaction.
d. Reduced financial burden on the patient and his/her family members.

Time period
Between 5th and 7th year after the project gets completed, all these four long-term outcomes shall be acquired.
 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "49"
Final Enrollment numbers achieved (India)="49" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2026 
Date of Study Completion (India) 30/06/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/06/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
The manuscript arising from the study findings has been submitted to BMC Medical Education and is under review.  
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [sundip.charmode@yahoo.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2027?
    Response - Immediately following publication. No end date.

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

Design: Quasi experimental study using mixed-method analysis

Settings: Department of Anatomy of AIIMS Rajkot

Sampling technique: Universal Sampling method.

Sample Size Calculation: Universal sampling method as all the available 50 first year medical students will be included after taking their informed consent.

Sample size (n) = Universal sampling of 1st year medical students.

Eligibility Criteria

Inclusion:

1.       1st MBBS students who will give informed consent.

Exclusion:

1.       1st MBBS students who will not give informed consent.

Data collection procedure: The study participants will be assessed before and after the module implementation. Pre-test before module implementation shall include assessment of metacognition awareness using a self-designed questionnaire which will be prepared from the currently available ‘Metacognition Awareness Inventory’ (MAI) 52-items scale in public domain. Copyright permission to use this scale for designing our scale has been successfully acquired. Additionally, an objective assessment (Pre-test) for assessing the domain specific for knowledge on the case will be conducted. Apart from these mentioned assessments, evaluation regarding the Readiness for Interprofessional Learning Scale using the (RIPLS) scale, creativity of the students using the ‘Short scale for creative self-efficacy’ (SSCS) and 26 items, Creative Self-Regulation (CSR) scale shall be done provided the copyright for the same is acquired and time feasibility. After the module implementation, Model Scoring Scale’ specifically designed for this project shall be used to assess the functional (working) models prepared by students for its creativity, problem-solving accuracy, followed by collaborative skills, and teamwork of the students. In addition, an objective assessment (Post-test) followed by module feedback from students and faculty and IP team shall be collected. The ‘Module Feedback Questionnaire’ and ‘Model Grading Scale’ have been specially designed for the project by the principal and co-investigators.

 
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