The Effectiveness of a Health Education Intervention to Reduce Anxiety in Quarantined COVID-19 Patients

NCT ID: NCT05715593

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-07-07

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Education

Group Type EXPERIMENTAL

health education intervention

Intervention Type OTHER

health education intervention

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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health education intervention

health education intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Monastir

OTHER

Sponsor Role lead

Responsible Party

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Imen Zemni

Medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fattouma Bourguiba University Hospital

Monastir, , Tunisia

Site Status

Countries

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Tunisia

References

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Zemni I, Gara A, Nasraoui H, Kacem M, Maatouk A, Trimeche O, Abroug H, Fredj MB, Bennasrallah C, Dhouib W, Bouanene I, Belguith AS. The effectiveness of a health education intervention to reduce anxiety in quarantined COVID-19 patients: a randomized controlled trial. BMC Public Health. 2023 Jun 20;23(1):1188. doi: 10.1186/s12889-023-16104-w.

Reference Type DERIVED
PMID: 37340300 (View on PubMed)

Other Identifiers

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UMONASTIR1

Identifier Type: -

Identifier Source: org_study_id

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