| CTRI Number |
CTRI/2016/02/006634 [Registered on: 15/02/2016] Trial Registered Prospectively |
| Last Modified On: |
12/02/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Survey |
| Study Design |
Other |
|
Public Title of Study
|
Stress amongst anesthesia residents: State wide survey |
|
Scientific Title of Study
|
Incidence and influence of stress amongst anesthesia residents: State wide survey |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Bakshi |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anesthesia, Critical Care & Pain,
Tata Memorial Hospital,
Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
24177058 |
| Fax |
|
| Email |
sumitrabakshi@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Bakshi |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anesthesia, Critical Care & Pain,
Tata Memorial Hospital,
Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
24177058 |
| Fax |
|
| Email |
sumitrabakshi@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Bakshi |
| Designation |
Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Department of Anesthesia, Critical Care & Pain,
Tata Memorial Hospital,
Parel, Mumbai.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
24177058 |
| Fax |
|
| Email |
sumitrabakshi@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia, Critical Care and Pain |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr E. Borges Road
Parel, Mumbai |
| Type of Sponsor |
Research institution and hospital |
|
|
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 S Bakshi |
Department of Anesthesia, Critical Care and Pain |
2nd floor
Main building
Tata Memorial Hospital,
Parel, Mumbai
Mumbai
MAHARASHTRA |
24177058
sumitrabakshi@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-1 |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Anesthesia Residents |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NA |
| Intervention |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
All anesthesia residents |
|
| ExclusionCriteria |
| Details |
Residents not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of stress using Cohen perceived stress scale
Impact of stress on students day to day life
willingness to participate in stress management programs |
One time filling of survey |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Work pattern of residents and influence on stress |
One time filling of survey |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800"
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)
|
15/02/2016 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Work stress amongst Anesthesia Residents is not unknown. We have planned a survey of all anesthesia residents in the state of Maharashtra, to understand their common stressors, and impact of stressors in their day to day life.
A twenty seven question based survey in English is designed after literature search and opinion from experienced anesthesiologists. Cohen perceived stress scale has been incorporated in the survey. Fourteen probable causes of stress have been looked into, with 6 questions on effect and seven on coping strategy. The questionnaire will be distributed by hand/ mail to all anesthesia residents in the state of Maharashtra. Act of filling the questionnaire and returning will imply consent. The identity of individual will not be captured thus assuring anonymity. The results from this survey will help in formulating further stress management programs for anesthesia residents.
|