Impact of COVID-19 Pandemic on the Psychological Wellbein... | NCT04469660

Studies
Impact of COVID-19 Pandemic on the Psychological Wellbeing of Healthcare Professionals in India

NCT04469660

Sponsor

Max Healthcare Insititute Limited

Status

Unknown status

Last Update Posted

Jul 14, 2020Actual

Enrollment

1,300Estimated

Phase

Not provided

Conditions

Psychological Stress

Interventions

Not provided

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 18, 2020Actual

Primary Completion Date

Aug 30, 2020Estimated

Completion Date

Sep 30, 2020Estimated

First Submitted Date

Jul 13, 2020

First Submission Date that Met QC Criteria

Jul 13, 2020

First Posted Date

Jul 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2020

Last Update Posted Date

Jul 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To Study the epidemiology of psychological distress among healthcare professionals of Max Super Speciality Hospital,Saket ,New Delhi in India during the COVID-19 Pandemic and assess the implications for providing psychological interventions(or therapeutic services)

Detailed Description

Hypothesis: There is likelihood of psychological distress impacting healthcare professionals' mental well-being as a result of their role in the healthcare setup during the COVID-19 pandemic. Study design-The questionnaire assessing the psychological wellbeing shall be administered via digital means of communication to healthcare professionals and support staff (doctors, nurses, paramedics, front office and support staff) across Max Super Speciality Hospital, Saket, New Delhi that currently employs 1295 individuals in the current category.

Participation in the study will be voluntary and informed consent will be sought prior to the survey administration. Participants' responses will remain anonymous, with an assurance of confidentiality.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Therapeutic Sessions emphasizing on Stress	The therapeutic sessions will emphasize on aspects of anxiety, depression, grief, post traumatic impact, loss, fear and so on, using standardized therapeutic techniques of psychotherapy. If the individual is in need of further management or somatic symptom related treatment, they will be guided for pharmacotherapy.	3 Months

Secondary Outcomes

Measure	Description	Time Frame
Resilience building and planning	Resilience building and planning will be implemented via individual, group and/or online based training portals to the cohort falling in the range of mild-moderate levels of psychological distress.	3 Months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria Healthcare professionals working in Max Super Speciality Hospital Saket New Delhi Healthcare professionals inclusive of doctors, nurses paramedics front office employee and support staff Healthcare professionals above 18 years of age Healthcare professionals residing in India

Exclusion Criteria Non-employees of Max Super Speciality Hospital Saket New Delh Healthcare professionals residing outside India

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Healthcare Professionals of Max Super Speciality Hospital,Saket,New Delhi

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Siddiqui	Contact	9911175205		hiba.siddiqui16@gmail.com
Ramandeep Arora	Contact	8375017305		childhoodcancer@gmail.com

Overall Officials

Name	Affiliation	Role
Hiba Siddiqui	Max Super Speciality Hospital,Saket,New Delhi	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Max Super Speciality Hospital Saket	Recruiting	New Delhi	National Capital Territory of Delhi	110017	India

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Yet not decided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013315	Stress, Psychological

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided