Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-02-25 @ 8:11 PM
Study NCT ID:
NCT04552392
Status:
COMPLETED
Last Update Posted:
2021-03-10
First Post:
2020-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychological Impact of Institutional Quarantine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-09', 'studyFirstSubmitDate': '2020-09-15', 'studyFirstSubmitQcDate': '2020-09-16', 'lastUpdatePostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'depression', 'timeFrame': 'Baseline', 'description': 'Beck Depression Inventory'}, {'measure': 'anxiety', 'timeFrame': 'Baseline', 'description': 'State Trait Anxiety Inventory'}, {'measure': 'perceived stress', 'timeFrame': 'Baseline', 'description': 'Perceived Stress Scale'}, {'measure': 'impact of life events', 'timeFrame': 'Baseline', 'description': 'Impact of Events Scale-Revised'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Quarantine']}, 'descriptionModule': {'briefSummary': 'Quarantine separates persons who have been potentially exposed to an infectious agent (and thus at risk for disease) from the general community. However, it may create psychological, emotional, and financial problems for some persons. The experience of those placed under quarantine in terms of compliance, difficulties, emotional response and psychological impact remains under-researched. In view of the increasing cases of COVID-19 in India and the rising numbers of people being quarantined as a precautionary measure, it was imperative to assess those quarantined for the psychological impact of the concerns regarding this illness and the quarantine procedure. In India, no such study had been undertaken and our study thus filled the research gap. The cross-sectional observational study aims at assessing the psychological impact of quarantine on Indian BSF jawans (n=100). They would be assessed for depression, anxiety, perceived stress level of impact, and impact of life events using Beck Depression Inventory, State Trait Anxiety Inventory, Perceived Stress Scale, and Impact of Events Scale-Revised. A qualitative interview schedule will also be carried out. Data would be analysed.', 'detailedDescription': 'Institutional quarantine separates persons who have been potentially exposed to an infectious agent (and thus at risk for disease) from the general community. This may create psychological, emotional, and financial problems for some persons. The experience of those placed under quarantine in terms of compliance, difficulties, emotional response and psychological impact remains under-researched.\n\nIn view of the increasing cases of COVID-19 in India and the rising numbers of people being quarantined as a precautionary measure, it was imperative to assess those quarantined for the psychological impact of the concerns regarding this illness and the quarantine procedure. In India, no such study had been undertaken and our study would thus fill the research gap.\n\nThe cross-sectional observational study is aimed at assessing the psychological impact of quarantine on Indian Border Security Force (BSF) soldiers (n=100).\n\nThe participants will be assessed for depression, anxiety, perceived stress level of impact, and impact of life events using Beck Depression Inventory, State Trait Anxiety Inventory, Perceived Stress Scale, and Impact of Events Scale-Revised respectively. A qualitative interview schedule will be carried out.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Jawana quarantined at Border Security Force Facility as a precautionary measure for COVID-19', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indian-origin adults between the age of 18-60 yrs quarantined at border security force facility\n* Both genders would be included\n\nExclusion Criteria:\n\n* Any chronic co-morbid medical condition\n* Current Diagnosis of COVID-19'}, 'identificationModule': {'nctId': 'NCT04552392', 'briefTitle': 'Psychological Impact of Institutional Quarantine', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Dr. Ram Manohar Lohia Hospital'}, 'officialTitle': 'Psychological Impact of Institutional Quarantine - A Cross-Sectional Observational Study', 'orgStudyIdInfo': {'id': 'COVID'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Delhi', 'country': 'India', 'facility': 'ITBP Chawala', 'geoPoint': {'lat': 28.65195, 'lon': 77.23149}}], 'overallOfficials': [{'name': 'Pragya Sharma, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ram Manohar Lohia Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Ram Manohar Lohia Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr Pragya Sharma', 'investigatorAffiliation': 'Dr. Ram Manohar Lohia Hospital'}}}}