| CTRI Number |
CTRI/2025/08/092416 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Poor sleep in Indian Anesthetists and its impact on work performance |
|
Scientific Title of Study
|
Prevalence of Poor Sleep Quality among Indian Anaesthesiologists and its Impact on Work Performance: A Nation-wide Cross-Sectional Study |
| 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 Kapil Singhal |
| Designation |
Director and Head of Department, Department of Anaesthesia and Critical Care |
| Affiliation |
Metro Hospitals & Heart Institute |
| Address |
HOD Room, 1st Floor, Department of Anaesthesiology and Critical Care, L-94, Sector 11, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9810384790 |
| Fax |
|
| Email |
kpl_dr@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Kritika Agrawal |
| Designation |
Consultant Anaesthesia |
| Affiliation |
Metro Hospitals & Heart Institute |
| Address |
HOD Room, 1st Floor, Department of Anaesthesiology and Critical Care, L-94, Sector 11, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
09899436567 |
| Fax |
|
| Email |
kritika.agrawal.4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kritika Agrawal |
| Designation |
Consultant Anaesthesia |
| Affiliation |
Metro Hospitals & Heart Institute |
| Address |
HOD Room, 1st Floor, Department of Anaesthesiology and Critical Care, L-94, Sector 11, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
09899436567 |
| Fax |
|
| Email |
kritika.agrawal.4@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Metro Hospitals & Heart Institute |
| Address |
L-94, Sector 11, Noida, Uttar Pradesh 201301 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Kritika Agrawal |
Metro Hospitals and Heart Institute |
HOD Room, 1st Floor, Department of Anaesthesia, L-94, Sector 11, Noida, Uttar Pradesh 201301
Gautam Buddha Nagar
UTTAR PRADESH |
09899436567
kritika.agrawal.4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Metro Ethical Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sleep quality |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
26.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Currently practicing anaesthesiologists
2. Working in India
3. At least 1 year of current clinical experience
|
|
| ExclusionCriteria |
| Details |
1. Not currently in clinical practice
2. Non-anaesthesia professionals
3. Suffering (currently/within past 1 month) from depression/anxiety/panic disorder/other psychiatric or mood disorder
4. Incomplete responses
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of participants with PSQI score more than 5, indicating poor sleep quality. |
Single administration during baseline survey (cross-sectional design).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of participants with excessive daytime sleepiness, defined as ESS (Epworth Sleepiness Scale) score more than 10. |
Single administration during baseline survey (cross-sectional design).
|
| Association between occupational factors (e.g. number of night shifts/month, total working hours/week, shift type) and PSQI/ESS scores |
Single administration during baseline survey (cross-sectional design). |
| Association between personal lifestyle factors (e.g. caffeine use, alcohol, smoking, stress) and PSQI/ESS scores. |
Measured concurrently in the same survey |
| Frequency of self-reported workplace impact due to poor sleep, including difficulty concentrating, fatigue, irritability etc. |
Retrospective self-report during the survey. |
|
|
Target Sample Size
|
Total Sample Size="376"
Sample Size from India="376"
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)
|
10/08/2026 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 cross-sectional, questionnaire-based observational study aims to assess sleep quality among Indian anaesthesiologists. There is limited data on sleep health among Indian anaesthesiologists, despite their high-risk work environment and irregular shifts. The study will use globally validated tools i.e. the Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) to measure key sleep-related outcomes. In addition, the study will gather data on occupational workload (shift pattern, night calls, working hours), lifestyle factors (caffeine, alcohol, smoking), and perceived stress at home and work. Respondents will also be asked about the perceived impact of sleep issues on clinical performance, including fatigue, concentration, and decreased productivity.
The primary outcome will be the proportion of participants with poor sleep quality, defined as PSQI score more than 5. Secondary outcomes include prevalence of excessive sleepiness (ESS more than 10), associations between risk factors and sleep scores, and the impact of poor sleep on work performance. The findings are expected to provide insight into the sleep health of anaesthesia professionals and suggest strategies to improve clinician well-being and patient care. |