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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04621214
Other study ID # IRBEC/BIH/013-2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 21, 2020
Est. completion date April 28, 2020

Study information

Verified date November 2020
Source University of Lahore
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

During the novel coronavirus pandemic, also known as SARS-CoV-2 or COVID-19 pandemic, frontline healthcare professionals suffered psychological as well as pathological trauma due to the lack of preparation to cope with this unforeseen situation. The protocols to prevent the spread of this disease proved to be less effective than anticipated. In these circumstances, improvement of the existing triage system was felt and an AUDIO-VISUAL TRIAGE (AVT) system was introduced to enhance confidence as well as increase the safety of frontline healthcare professionals. The current analysis was performed from March 21, 2020, to April 28, 2020, until the completion of sixty response forms, at Bahria Town International Hospital, Lahore. Thirty participants (Group A) deployed on visual triage and other thirty (Group B) on Audio-Visual triage for screening suspected cases of COVID-19 infection. Anxiety levels were measured by using the GAD-7 scoring system and the participants of both groups were periodically tested for COVID-19 infection by PCR. Independent t-test was used to evaluate the significance of different variables at a confidence level of 95%.


Description:

A novel strategy 'Audio-Visual Triage' was introduced to boost up the confidence levels, lower down the anxiety levels and the most important factor is to reduce the risk of COVID-19 infection spread. This Triage system included Audio system to communicate with patients and access the COVID-19 infection status at recommended distance of 6 feet. The main disturbing factors that were noted on Visual triage system were, 1). Close contact of healthcare professionals with patients and attends, 2). Fear of transmission of infection lead to higher levels of anxiety. To assess the efficiency of AVT Anxiety level were analyzed by using Spitzer et al., 2006, General Anxiety Disorder-7 (GAD-7) scoring system and outcomes were assessed where a score less than 5 is taken as no anxiety, 5-9 interpreted as mild anxiety, 10-14 moderate anxiety, and ≥ 15 as severe anxiety levels.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 28, 2020
Est. primary completion date April 28, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 38 Years
Eligibility Inclusion Criteria: - Participants performing their duty on visual triage. Exclusion Criteria: - Those participants having previous psychological illness, frequently used to use the washroom, had non-serious attitude and poor compliance with the protocols of wearing PPEs were excluded from the study.

Study Design


Intervention

Device:
Audio-Visual Triage System (AVT)
Audio System was added to visual triage that resulted in an AVT. Protocols of AVT included, a medical personal sits on TRIAGE DESK (with glass barrier sheet on it) wearing personal protective equipment (PPE) at a distance of more than 6 feet from the PATIENT DESK. Both desks are connected with Non-touchable MIC SYSTEM for communication

Locations

Country Name City State
Pakistan The University of Lahore Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Polymerase chain reaction (PCR) to detect SARS-CoV-2 virus Every participant was test for COVID-19 infection by PCR. At the end of the study we compare the Number of participant infected by Corona virus in Both groups. 12-24 hours
Primary General Anxiety Disorder-7 (GAD-7) scoring system The GAD-7 is used to measure the severity of anxiety. Score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions.
Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD. It is moderately good at screening three other common anxiety disorders - panic disorder (sensitivity 74%, specificity 81%), social anxiety disorder (sensitivity 72%, specificity 80%) and post-traumatic stress disorder (sensitivity 66%, specificity 81%
15 - 20 minutes
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