| 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
|
|
|
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
|
|
|
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. |