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CTRI Number  CTRI/2024/07/070424 [Registered on: 10/07/2024] Trial Registered Prospectively
Last Modified On: 09/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational intervention]  
Study Design  Other 
Public Title of Study   A study to implement counselling skill module among the MBBS students  
Scientific Title of Study   Development and implementation of Counselling Skills in MBBS students pertaining to Caregivers of Malnourished Children 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhishek Kumar 
Designation  Assistant Professor 
Affiliation  Manipal Tata Medical College, Manipal Academy of Higher Education, Manipal, India 
Address  Dept. of Community Medicine 1st Floor, New Academic Block Kadani Road, Baridih Jamshedpur East Singhbhum JHARKHAND 831017 India

Purbi Singhbhum
JHARKHAND
831017
India 
Phone  9525808606  
Fax    
Email  abhi.kumar@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Abhishek Kumar 
Designation  Assistant Professor 
Affiliation  Manipal Tata Medical College, Manipal Academy of Higher Education, Manipal, India 
Address  Dept. of Community Medicine 1st Floor, New Academic Block Kadani Road, Baridih, Jamshedpur East Singhbhum JHARKHAND 831017 India

Purbi Singhbhum
JHARKHAND
831017
India 
Phone  9525808606  
Fax    
Email  abhi.kumar@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Abhishek Kumar 
Designation  Assistant Professor 
Affiliation  Manipal Tata Medical College, Manipal Academy of Higher Education, Manipal, India 
Address  Dept. of Community Medicine, 1st Floor, New Academic Block Kadani Road, Baridih Jamshedpur East Singhbhum Jharkhand 831017 India

Purbi Singhbhum
JHARKHAND
831017
India 
Phone  9525808606  
Fax    
Email  abhi.kumar@manipal.edu  
 
Source of Monetary or Material Support  
No funding is there for the project. Infrastructure support by - Manipal Tata Medical College Kadani Road, Baridih Jamshedpur Dist. East Singhbhum Jharkhand - 831017 
 
Primary Sponsor  
Name  00 
Address  00 
Type of Sponsor  Other [00] 
 
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 Abhishek Kumar  Manipal Tata Medical College, Jamshedpur   Room no: 143; Department of community medicine; Kadani Road, Baridih, Jamshedpur Dist. - Purbi Singhbhum
Purbi Singhbhum
JHARKHAND 
9525808606

abhi.kumar@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MTMC IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy young vouulnteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Educational intervention about counselling  Counselling skills will be taught to MBBS students pertaining to the care givers of Malnourished children. The total duration of the intervention along with assessment will be around 6 hpurs. 
Comparator Agent  Not Applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Phase II MBBS Students 
 
ExclusionCriteria 
Details  Other phase MBBS students and Students who don’t give consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
a. Validated counselling module for MBBS students pertaining to caregivers ofmalnourishedchildren. b. Learning of the counselling skills to counsel caregivers of malnourished children by MBBS students. c. Improved counselling skills of MBBS students measured based on score obtained in Counsellor Cmpetency Scale-Revised scale.   12 Months 
 
Secondary Outcome  
Outcome  TimePoints 
a. Motivated caregivers of the malnourished children to take care of their child meticulously
b. Attainment normal growth curve rapidly by the malnourished child. 
12 months 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   02/09/2024 
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="1"
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   Aim(s) and objective(s) of the study: To develop a counselling module for MBBS students pertaining to caregivers of a malnourished child and to assess the knowledge and counselling skill of students after teaching.
module for counselling skills pertaining to the caregivers of a malnourished child will be developed for phase II MBBS students which will be validated by senior faculty members, medical education experts and FAIMER fellows and will be achieved in the first year of project. Then the investigator will design a pre-test question for knowledge and simulated OSCE stations for skill assessment of students. From the Phase II, 25 MBBS students will be selected from those posted for clinical posting who will undergo pre-test & OSCE in simulated parent of a malnourished child for assessment. After assessment MBBS students will be taught about the developed counselling skills module. The total expected duration of teaching of the module will be around six hours. While the MBBS students will visit NRC during their clinical posting they will demonstrate the counselling skills on real caregivers of malnourished child. At the same time skills and knowledge of counselling will be assessed using
the CCS-R Scale (Lambie, Mullen, & Swank, & Blount 2014). Data obtained from both the pre and post test score of MBBS students will be collected and kept for record and compiled for analysis. The mean score of both pre & post class assessment will be calculated to see the change in skills of counselling of MBBS students. The phase II MBBS students of other batches of clinical posting will also be educated and trained about the module in same manner in subsequent classes. Operational definition of caregiver – A caregiver can be any person (Parents, Grandparents, caretaker, guardian, elder brother and sister) who will be accompanying the malnourished child.
 
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