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

May 28, 2020 updated by: Veerle Van Mossevelde, Universitair Ziekenhuis Brussel

Effect on the COVID-19 Pandemic-induced Reduction in Elective Surgery on Medical Events and Psychological Well-being of Patients Waiting for Cardiac Surgery

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Vlaams Brabant
      • Jette, Vlaams Brabant, Belgium, 1090
        • Recruiting
        • Universitair Ziekenhuis Brussel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: operation deferred
Adult patients whose operation date has been deferred due to the pandemic
Behavioral: HADS
Hospital Anxiety and Depression Scale
Other Names:
  • questionnaire
Behavioral: a survey
made up specifically for issues concerning the medical/psychological/access aspects during the COVID-19 outbreak
Other: no operation date
Patients who did not have had an operation date and who were told to need cardiac surgery before the pandemic started
Behavioral: HADS
Hospital Anxiety and Depression Scale
Other Names:
  • questionnaire
Behavioral: a survey
made up specifically for issues concerning the medical/psychological/access aspects during the COVID-19 outbreak
Other: postoperative consultation deferred
Patients who have been operating on during the month before the pandemic
Behavioral: HADS
Hospital Anxiety and Depression Scale
Other Names:
  • questionnaire
Behavioral: a survey
made up specifically for issues concerning the medical/psychological/access aspects during the COVID-19 outbreak

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety/depression by means of Hospital Anxiety and Depression Scale (HADS)
Time Frame: 10 minutes
The degree of anxiety and/or depression in all three groups, induced by their altered medical care trajectory. 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)
10 minutes
Medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit
Time Frame: 10 minutes
The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit by means of an adjusted survey.
10 minutes
Reduced access to medical and psychological help
Time Frame: 10 minutes
The occurrence of reduced access to medical and psychological help by means of an adjusted survey.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Investigators

  • Principal Investigator: Jan Nijs, MD, Universitair Ziekenhuis Brussel
  • Study Director: Mark La Meir, Phd, MD, Universitair Ziekenhuis Brussel
  • Study Chair: Ashley Welch, MD, Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2020

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

April 28, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

June 1, 2020

Last Update Submitted That Met QC Criteria

May 28, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-19 Cardiac psy wellbeing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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