Psychological StressNCT04469660
Impact of COVID-19 Pandemic on the Psychological Wellbeing of Healthcare Professionals in India
An observational study of Psychological Stress, run by Max Healthcare Insititute Limited at 1 site in India.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress
- How many people
- 1,300 participants
- Where
- 1 siteIndia
- Study dates
- 18 May 2020to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthcare Professionals of Max Super Speciality Hospital,Saket,New Delhi
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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Max Super Speciality Hospital Saket
New Delhi, National Capital Territory of Delhi, 110017
Hiba Siddiqui, 9911175205, hiba.siddiqui16@gmail.com
Ramandeep S Arora, 8375017305, childhoodcancer@gmail.com
About this study
Official title: Impact of COVID-19 Pandemic on the Psychological Wellbeing of Healthcare
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)
Read the detailed description
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).
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.
- Conditions
- Psychological Stress
- Medical subject headings
- Stress, Psychological
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months
Secondary outcomes (1)
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.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start18 May 2020
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Max Healthcare Insititute Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hiba Siddiqui, Principal investigator, Max Super Speciality Hospital,Saket,New Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469660
- Sponsor's protocol ID
- Onco Survey_COVID-19
- Status last verified
- Jul 2020
- First submitted
- 13 Jul 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yet not decided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 Pandemic on the Psychological Wellbeing of Healthcare
- ClinicalTrials.gov ID
- NCT04469660
- Acronym / sponsor ID
- Onco Survey_COVID-19
- Conditions
- Psychological Stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Max Healthcare Insititute LimitedUniversity, hospital or other
- Study start
- 18 May 2020 (actual)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare Professionals of Max Super Speciality Hospital,Saket,New Delhi
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Therapeutic Sessions emphasizing on Stress
Time frame: 3 Months
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.
1 secondary outcome
Resilience building and planning
Time frame: 3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: Undecided. Yet not decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiba Siddiqui principal investigator
Max Super Speciality Hospital,Saket,New Delhi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Stress, run by Max Healthcare Insititute Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siddiqui (9911175205, hiba.siddiqui16@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic Sessions emphasizing on Stress (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.