| 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
|
|
|
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
|
|
|
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
- 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).
- 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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [sundip.charmode@yahoo.com].
- 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.
- 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. |