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

Not Applicable

• Conditions: Anxiety Depression; Anxiety Postoperative; Anxiety and Fear; Psychological Stress
• Interventions: Behavioral: HADS; Behavioral: a survey

• Registration Number: NCT04406181
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Study Timeline

• Study First Submitted: 2020-04-28
• Status Verified: 2020-05
• Study Start: 2020-05-18
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-28
• Last Update Submitted: 2020-05-28
• Last Update Posted: 2020-06-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit	10 minutes	The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit by means of an adjusted survey.
Reduced access to medical and psychological help	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)	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)

Trial Locations

Locations (1)

universitair Ziekenhuis Brussel; 🇧🇪 Jette, Vlaams Brabant, Belgium