Clinical trial NCT04406181: Psychological Well-being of Patients Awaiting for Cardiac Surgery During the COVID-19 Pandemic
Official title: Effect on the COVID-19 Pandemic-induced Reduction in Elective Surgery on Medical Events and Psychological Well-being of Patients Waiting for Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety and Fear
Anxiety Depression
Anxiety Postoperative
Psychological Stress
Keywords: cardiac surgery
postoperative consultation
postponed elective surgery
COVID-19
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety/depression by means of Hospital Anxiety and Depression Scale (HADS)
timeFrame: 10 minutes
measure: Medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit
timeFrame: 10 minutes
measure: Reduced access to medical and psychological help
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: universitair Ziekenhuis Brussel
state: Vlaams Brabant
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Jan Nijs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Mark La Meir, Phd, MD
role: STUDY_DIRECTOR
affiliation: Universitair Ziekenhuis Brussel
name: Ashley Welch, MD
role: STUDY_CHAIR
References: