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CTRI Number  CTRI/2024/01/061910 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 26/01/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessment of psychological well being of undergraduate medical students  
Scientific Title of Study   Impact of Personality Traits, Emotional Intelligence and Coping Strategies on Psychological Well-Being of Undergraduate Medical Students. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tanmay Gill 
Designation  Undergraduate Medical Student 
Affiliation  Maulana Azad Medical College 
Address  Department of physiology, Room 146, 2nd floor pathology block, MAMC

Central
DELHI
110002
India 
Phone  7055142185  
Fax    
Email  parthtanmaypapa@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Preeti Jain 
Designation  Professor 
Affiliation  Maulana Azad Medical College Delhi 
Address  Department of physiology, Room number 146, 2nd floor, Pathology block Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi.

Central
DELHI
110002
India 
Phone  9868259394  
Fax    
Email  drpreetijain@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Preeti Jain 
Designation  Professor 
Affiliation  Maulana Azad Medical College Delhi 
Address  Department of physiology, Room number 146, 2nd floor, Pathology block, Maulana Azad Medical College, New Delhi.

Central
DELHI
110002
India 
Phone  9868259394  
Fax    
Email  drpreetijain@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College  
 
Primary Sponsor  
Name  Tanmay Gill 
Address  Department of physiology, 2nd floor pathology block, Maulana Azad Medical College, New Delhi 
Type of Sponsor  Other [Self sponsor ] 
 
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 
Tanmay Gill  Maulana Azad Medical College, Lok Nayak Hospital  Department of physiology, room number 146, 2nd floor pathology block, MAMC Delhi.
Central
DELHI 
7055142185

parthtanmaypapa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maulana Azad Medical College And Associated Hospital, Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy undergraduate medical students belonging to the age group of 18 to 25 years. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Healthy undergraduate medical students of the institute of either sex in the
age group 18 to 25 years who are willing to participate in the study. •
 
 
ExclusionCriteria 
Details  Students with diagnosed psychiatric illness or any prescribed medication for psychiatric disorder will be excluded.
Subjects otherwise healthy but returning incomplete questionnaires will be excluded too. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Personality traits
Psychological well being
Emotional intelligence
Coping strategies  
The results of the study will be assessed and analysed after 5 weeks of recruitment of the questionnaires. 
 
Secondary Outcome  
Outcome  TimePoints 
Identification of modifiable traits  The results of the study will be analysed 2 weeks after the responses have been collected 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   05/02/2024 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Psychological well-being (PWB) is a multifaceted dynamic concept that refers to a combination of feeling good and functioning effectively. It incorporates both hedonic (pleasure) and eudaemonic (fulfilment) happiness in the present as well as, contentment and satisfaction for the past along with optimism for the future [3]. The multiple facets of PWB include mutually interdependent dimensions such as self-acceptance, positive relations, autonomy in thought and action, environmental mastery, the sense of purpose in life and personal growth [4]. There is a strong possibility that many of the factors that influence PWB might not be the same as those implicated as contributory risk factors towards increased mental distress and behavioural problems. Hence, exploration of PWB is a promising new area of research in promoting positive mental health. Data will be collected using self-reported, pre-tested, online versions of questionnaires (in English Language) on psychological well-being, Big five personality traits, emotional intelligence and Coping Strategies. The questionnaires will be adapted in google forms, and the link for filling them up would be sent to the participating students in breaks from teaching schedule or after the completion of lectures. For each measure, a separate google form would be made. The subjects would be requested to submit the completed google forms for all questionnaires on the same day. Completion of the questionnaires will be voluntary and will not affect their progression in medical course. They will be asked to fill a case study form about their socio demographic scale details and history of any psychiatric illness (yes/no) and/or medication. They will be asked to fill the Ryff’s PWB scale, Big five international personality item pool (Big-5 IPIP), Trait emotional intelligence questionnaire short form (TEIQue-sf) and the brief COPE inventory in this order. Filling of all the questionnaires would take approximately 30-45 minutes. The present study has been planned with the aim of assessing the psychological well-being of the undergraduate students of our institute, and to investigate which specific personality traits, elements of emotional intelligence and the choice of coping strategy used by the subject is leading to deviation from well-being. To the best of our knowledge, till date no study has as yet attempted to take into consideration a cumulative effect of all these elements to examine psychological well-being in our country.

One of the key aspects of the study is the identification of modifiable traits with regards to personality and/or emotional intelligence and the choice of coping strategy which the subject can consciously modify so as to have a positive effect on the psychology of the subject.

 
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