| 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
|
|
|
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
|
|
|
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. |