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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04552392
Other study ID # COVID
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 20, 2020
Est. completion date October 20, 2020

Study information

Verified date March 2021
Source Dr. Ram Manohar Lohia Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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. 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 would thus fill the research gap. The cross-sectional observational study is aimed at assessing the psychological impact of quarantine on Indian Border Security Force (BSF) soldiers (n=100). The 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.


Recruitment information / eligibility

Status Completed
Enrollment 176
Est. completion date October 20, 2020
Est. primary completion date October 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Indian-origin adults between the age of 18-60 yrs quarantined at border security force facility - Both genders would be included Exclusion Criteria: - Any chronic co-morbid medical condition - Current Diagnosis of COVID-19

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
India ITBP Chawala Delhi

Sponsors (1)

Lead Sponsor Collaborator
Dr. Ram Manohar Lohia Hospital

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary depression Beck Depression Inventory Baseline
Primary anxiety State Trait Anxiety Inventory Baseline
Primary perceived stress Perceived Stress Scale Baseline
Primary impact of life events Impact of Events Scale-Revised Baseline