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

U

Universitair Ziekenhuis Brussel

Status

Unknown

Conditions

Psychological Stress
Anxiety Depression
Anxiety and Fear
Anxiety Postoperative

Treatments

Behavioral: a survey
Behavioral: HADS

Study type

Interventional

Funder types

Other

Identifiers

NCT04406181
COVID-19 Cardiac psy wellbeing

Details and patient eligibility

About

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

Full description

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 3 patient groups

operation deferred
Other group
Description:
Adult patients whose operation date has been deferred due to the pandemic
Treatment:
Behavioral: a survey
Behavioral: HADS
no operation date
Other group
Description:
Patients who did not have had an operation date and who were told to need cardiac surgery before the pandemic started
Treatment:
Behavioral: a survey
Behavioral: HADS
postoperative consultation deferred
Other group
Description:
Patients who have been operating on during the month before the pandemic
Treatment:
Behavioral: a survey
Behavioral: HADS

Trial contacts and locations

1

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Central trial contact

Veerle Van Mossevelde, Data Nurse

Data sourced from clinicaltrials.gov

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