| CTRI Number |
CTRI/2025/06/088189 [Registered on: 03/06/2025] Trial Registered Prospectively |
| Last Modified On: |
03/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Workload and its effect on the happiness of residents. |
|
Scientific Title of Study
|
A Follow up Study to assess Burnout, Workload and Happiness Index among PG Medical Residents |
| 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 Manthan Narendrabhai Patel |
| Designation |
First year resident |
| Affiliation |
Govt. Medical college Bhavnagar |
| Address |
Dept. of psychiatry, Sir T Hospital Bhavnagar.
Plot no - 1589/A2 behind Laxmi Appartment, Sardarnagar, Bhavnagar.
Bhavnagar
GUJARAT
364001
India |
| Phone |
8160362353 |
| Fax |
|
| Email |
drmanthanpatel03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok U Vala |
| Designation |
Proffesor and Head |
| Affiliation |
Govt. Medical college Bhavnagar |
| Address |
Dept. of Psychiatry, Sir T Hospital Bhavnagar.
“AKSHDAâ€,Plot No.-2,
Pattani Park, Anantwadi,
Bhavnagar – 364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427774959 |
| Fax |
|
| Email |
dr175vala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok U Vala |
| Designation |
Proffesor and Head |
| Affiliation |
Govt. Medical college Bhavnagar |
| Address |
Dept. of Psychiatry, Sir T Hospital Bhavanagr.
“AKSHDAâ€,Plot No.-2,
Pattani Park, Anantwadi,
Bhavnagar – 364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427774959 |
| Fax |
|
| Email |
dr175vala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Sir T Hospital Bhavnagar |
|
|
Primary Sponsor
|
| Name |
Dr MANTHAN NARENDRABHAI PATEL |
| Address |
plot no: 1589/A2 behind laxmi appartment sardarnagar bhavnagar |
| Type of Sponsor |
Other [Self] |
|
|
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 Manthan Patel |
Govt. Medical College and Sir T Hospital Bhavnagar |
Department of Psychiatry, Sir T Hospital Bhavnagar.
Bhavnagar
GUJARAT |
8160362353
drmanthanpatel03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PG residents BATCH 2023 of govt. medical college Bhavnagar. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All the medical PG Residents of batch 2023 willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.PG Residents of batch 2023 not willing to give consent
2.PG Residents of batch 2023 already on any psychotropic medication since last 2 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| As the workload among the PG residents increases, it eventually causes burnout in those residents. |
27 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PG residents with lesser burnout are happier than the ones who are more burned out. |
27 MONTHS |
|
|
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)
|
14/06/2025 |
| 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="2"
Months="3"
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
|
This study is carried out to assess the burnout and happiness levels among the First Year Medical PG Residents at regular intervals of 6 months and also explore its co-relation with the workload with the help of appropriate tools and regular follow up. |