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Clinical Trials/NCT04406181
NCT04406181
Unknown
Not Applicable

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

Universitair Ziekenhuis Brussel1 site in 1 country200 target enrollmentMay 18, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety and Fear
Sponsor
Universitair Ziekenhuis Brussel
Enrollment
200
Locations
1
Primary Endpoint
Reduced access to medical and psychological help
Last Updated
5 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
May 18, 2020
End Date
January 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Veerle Van Mossevelde

Data Nurse

Universitair Ziekenhuis Brussel

Eligibility Criteria

Inclusion Criteria

  • All adult patients whose operation date has been deferred due to the pandemic COVID-
  • All patients who did not have had an operation date before the pandemic COVID-
  • All patients who have been operating on during the month before the pandemic COVID-19.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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)

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.

Study Sites (1)

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