The Effectiveness of a Health Education Intervention to Reduce Anxiety in Quarantined COVID-19 Patients: A Randomized Controlled Trial

University of Monastir1 site in 1 country402 target enrollmentFebruary 1, 2021

ConditionsHealth Education, COVID-19, Quarantine, Anxiety, Pandemic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Health Education, COVID-19, Quarantine, Anxiety, Pandemic
Sponsor: University of Monastir
Enrollment: 402
Locations: 1
Primary Endpoint: The rate of anxiety reduction
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

we aimed to assess the impact of health education on the anxiety level of COVID-19 patients during the isolation period.

Detailed Description

This is a randomized controlled trial conducted between February 2021 and June 2021. Patients tested positive for Covid-19 with mild to moderate forms were randomized to Education (n=267) or control (n=269). The education group received a phone health education session on day 1 (D1) following the diagnosis. The three components of the health education intervention were an explanation of the coronavirus disease, what to do in the event of complications, and the recommended preventive measures. The two groups received a telephone evaluation of their Hospital Anxiety and Depression scores on (D1) and day seven D7 following the positive diagnosis. The primary outcome was the rate of anxiety reduction in each group at D7 based on a HAD-A score ≥ 8. Secondary outcomes were the rate of anxiety reduction at D7 based on a HAD-A score ≥ 11, the percentage of people complying with isolation and the scores of adherence to preventive measures during the isolation in each group.

Registry

clinicaltrials.gov

Start Date

February 1, 2021

End Date

July 7, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Monastir

Responsible Party

Principal Investigator

Imen Zemni

Medical doctor

University of Monastir

Eligibility Criteria

Inclusion Criteria

•Patients diagnosed with Covid-19 after positive PCR or positive antigen rapid test, over 18 years of age, who did not require hospitalization

Exclusion Criteria

•Patients not reachable at the first day phone call of the diagnosis and patients unable to answer the telephone questionnaire due to their cognitive state.