| CTRI Number |
CTRI/2020/05/025344 [Registered on: 25/05/2020] Trial Registered Prospectively |
| Last Modified On: |
31/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effects of the corona virus disease on mental health of Anaesthesiologists working at different parts of India. |
|
Scientific Title of Study
|
Effects of the COVID-19 Pandemic on mental health of Anaesthesiologists working at different parts of India. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Neha Singh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Pin-751019 Odisha, India
Khordha
ORISSA
751019
India |
| Phone |
9438884045 |
| Fax |
|
| Email |
anaes_neha@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Neha Singh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Pin-751019 Odisha, India
Khordha
ORISSA
751019
India |
| Phone |
9438884045 |
| Fax |
|
| Email |
anaes_neha@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DR Neha Singh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Pin-751019 Odisha, India
Khordha
ORISSA
751019
India |
| Phone |
9438884045 |
| Fax |
|
| Email |
anaes_neha@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Bhubaneswar |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Bhubaneswar |
| Address |
All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Pin-751019 Odisha, India |
| 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 Neha Singh |
All India Institute of Medical Sciences, Bhubaneswar |
Room No. 154, Department of Anaesthesiology All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Pin-751019
Khordha
ORISSA
Khordha
ORISSA |
9438884045
anaes_neha@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Anaesthesiologists working in emergencies, operation theatres and critical care units/ ICUs. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Anaesthesiologists of either sex aged 28 – 65 years taking care of patients during COVID-19 pandemic. |
|
| ExclusionCriteria |
| Details |
Not willing to take the survey |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the psychological impact of COVID-19 pandemic on Anaesthesiologists working at different parts of India during the COVID -19 pandemic. |
After completion of the survey. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="237" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/06/2020 |
| Date of Study Completion (India) |
04/11/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Anesthesiology
has been identified as a stressful specialty due to various factors like production
pressures, long working hours, night call and fatigue. (1, 2) There are few
Indian studies in Anaesthesiologists to identify these stressors and ways to
reduce them. In this COVID-19 pandemic anaesthesiologists are frontline
professionals involved in patient care at emergency, operation theatre and
ICUs. Increasing
number of confirmed and suspected cases day by day, depletion of personal
protection equipment, widespread media coverage, lack of specific drugs, and
feelings of being inadequately supported may all contribute to the mental burden
and stress. (3) Psychological effect of these added factors may pose a risk of variety of psychiatric illnesses like;
depression, anxiety disorders, substance abuse, suicide and Post traumatic
stress disorder (PTSD).(4) We have planned to assess the mental health effects
of COVID-19 pandemic affecting the anaesthesiologists by using standardizes
self-reported questionnaires in terms of experiencing subsyndromal depression,
anxiety and stress.
References:
1.
1.Kain
ZN, Chan KM, Katz JD, Nigam A, Fleisher L, Dolev J, et al. Anaesthesiologists
and acute perioperative stress: A cohort study. Anesth Analg 2002;95:177-83.
2. 2. Bakshi
SG, Divatia JV, Kannan S, Myatra SN. Work-related stress: A survey of Indian
anesthesiologists. J Anaesthesiol Clin Pharmacol. 2017 Jan-Mar;33(1):86-91.
doi: 10.4103/joacp.JOACP_390_15. PMID: 28413278; PMCID: PMC5374836.
3.
3. Lai
J, Ma S, Wang Y, et al. Factors Associated With Mental Health Outcomes Among
Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open.
2020;3(3):e203976. doi:10.1001/jamanetworkopen.2020.3976
4. Shanafelt T, Ripp J, Trockel M. Understanding
and Addressing Sources of Anxiety Among Health Care Professionals During the
COVID-19 Pandemic. JAMA. Published online April 07, 2020.
doi:10.1001/jama.2020.5893. |