Psychological Well-being of Patients Awaiting for Cardiac Surgery During the COVID-19 Pandemic

NCT ID: NCT04406181

Last Updated: 2020-06-01

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-18

Study Completion Date

2021-01-01

Brief Summary

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The effect and impact of postponing cardiac surgery / creating a waiting list as a result of COVID-19 on patients, both psychologically and symptomatically on three groups of patients:

1. The degree of anxiety and/or depression induced by their altered medical care trajectory.
2. The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit
3. The occurrence of reduced access to medical and psychological help

Detailed Description

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A prospective study by means of a questionnaire, specifically designed for each of the three groups.

1. Adult patients whose operation date has been deferred
2. Patients who did not have had an operation date
3. Patients who have been operating on during the month before

Each group will receive a twofold questionnaire:

Part I: Hospital Anxiety and Depression Scale (HADS), a robust questionnaire used for hospitalized and non-hospitalized patients gauging the degree of anxiety and/or depression, irrespective of their specific medical condition. All three groups receive the same list of questions.

-Part II: a questionnaire made up specifically for issues concerning the medical/psychological/access aspects during the COVID-19 outbreak. Each of the three groups will receive a questionnaire, adapted to the group they are assigned to.

The questionnaires will be delivered by the use of Qualtrics or on paper. Timing and mode of presentation (Qualtrics or fill-in paper on admission) of the questionnaire will depend on the length of the quarantine measures.

Conditions

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Anxiety and Fear Anxiety Depression Anxiety Postoperative Psychological Stress

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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operation deferred

Adult patients whose operation date has been deferred due to the pandemic

Group Type OTHER

HADS

Intervention Type BEHAVIORAL

Hospital Anxiety and Depression Scale

a survey

Intervention Type BEHAVIORAL

made up specifically for issues concerning the medical/psychological/access aspects during the COVID-19 outbreak

no operation date

Patients who did not have had an operation date and who were told to need cardiac surgery before the pandemic started

Group Type OTHER

HADS

Intervention Type BEHAVIORAL

Hospital Anxiety and Depression Scale

a survey

Intervention Type BEHAVIORAL

made up specifically for issues concerning the medical/psychological/access aspects during the COVID-19 outbreak

postoperative consultation deferred

Patients who have been operating on during the month before the pandemic

Group Type OTHER

HADS

Intervention Type BEHAVIORAL

Hospital Anxiety and Depression Scale

a survey

Intervention Type BEHAVIORAL

made up specifically for issues concerning the medical/psychological/access aspects during the COVID-19 outbreak

Interventions

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HADS

Hospital Anxiety and Depression Scale

Intervention Type BEHAVIORAL

a survey

made up specifically for issues concerning the medical/psychological/access aspects during the COVID-19 outbreak

Intervention Type BEHAVIORAL

Other Intervention Names

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questionnaire

Eligibility Criteria

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Inclusion Criteria

All adult patients whose operation date has been deferred due to the pandemic COVID-19.

All patients who did not have had an operation date before the pandemic COVID-19.

All patients who have been operating on during the month before the pandemic COVID-19.

Exclusion Criteria

N/A
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Veerle Van Mossevelde

Data Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Nijs, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Mark La Meir, Phd, MD

Role: STUDY_DIRECTOR

Universitair Ziekenhuis Brussel

Ashley Welch, MD

Role: STUDY_CHAIR

Universitair Ziekenhuis Brussel

Locations

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universitair Ziekenhuis Brussel

Jette, Vlaams Brabant, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Veerle Van Mossevelde, Data Nurse

Role: CONTACT

+3224763134

Facility Contacts

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Veerle Van Mossevelde

Role: primary

+3224763134

Other Identifiers

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COVID-19 Cardiac psy wellbeing

Identifier Type: -

Identifier Source: org_study_id

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