Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-30 @ 10:21 AM
Study NCT ID:
NCT04469660
Status:
UNKNOWN
Last Update Posted:
2020-07-14
First Post:
2020-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of COVID-19 Pandemic on the Psychological Wellbeing of Healthcare Professionals in India
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-13', 'studyFirstSubmitDate': '2020-07-13', 'studyFirstSubmitQcDate': '2020-07-13', 'lastUpdatePostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Therapeutic Sessions emphasizing on Stress', 'timeFrame': '3 Months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Resilience building and planning', 'timeFrame': '3 Months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychological Stress']}, 'descriptionModule': {'briefSummary': '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)', 'detailedDescription': "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).\n\nHypothesis: 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.\n\nParticipation 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthcare Professionals of Max Super Speciality Hospital,Saket,New Delhi', 'healthyVolunteers': True, 'eligibilityCriteria': '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\n\nExclusion Criteria Non-employees of Max Super Speciality Hospital Saket New Delh Healthcare professionals residing outside India'}, 'identificationModule': {'nctId': 'NCT04469660', 'briefTitle': 'Impact of COVID-19 Pandemic on the Psychological Wellbeing of Healthcare Professionals in India', 'organization': {'class': 'OTHER', 'fullName': 'Max Healthcare Insititute Limited'}, 'officialTitle': 'Impact of COVID-19 Pandemic on the Psychological Wellbeing of Healthcare', 'orgStudyIdInfo': {'id': 'Onco Survey_COVID-19'}}, 'contactsLocationsModule': {'locations': [{'zip': '110017', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Hiba Siddiqui', 'role': 'CONTACT', 'email': 'hiba.siddiqui16@gmail.com', 'phone': '9911175205'}, {'name': 'Ramandeep S Arora', 'role': 'CONTACT', 'email': 'childhoodcancer@gmail.com', 'phone': '8375017305'}], 'facility': 'Max Super Speciality Hospital Saket', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'centralContacts': [{'name': 'Siddiqui', 'role': 'CONTACT', 'email': 'hiba.siddiqui16@gmail.com', 'phone': '9911175205'}, {'name': 'Ramandeep Arora', 'role': 'CONTACT', 'email': 'childhoodcancer@gmail.com', 'phone': '8375017305'}], 'overallOfficials': [{'name': 'Hiba Siddiqui', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Max Super Speciality Hospital,Saket,New Delhi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Yet not decided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Max Healthcare Insititute Limited', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}