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

Psychological Stress Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04406181
• Other study ID #: COVID-19 Cardiac psy wellbeing
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2020
• Est. completion date: January 1, 2021

Study information

• Verified date: May 2020
• Source: Universitair Ziekenhuis Brussel
• Contact: Veerle Van Mossevelde, Data Nurse
• Phone: +3224763134
• Email: veerle.vanmossevelde[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety and Fear
• Anxiety Depression
• Anxiety Disorders
• Anxiety Postoperative
• Psychological Stress
• Stress, Psychological

Intervention

Behavioral:
• HADS
Hospital Anxiety and Depression Scale
• a survey
made up specifically for issues concerning the medical/psychological/access aspects during the COVID-19 outbreak

Locations

Country	Name	City	State
Belgium	universitair Ziekenhuis Brussel	Jette	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety/depression by means of Hospital Anxiety and Depression Scale (HADS)	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
Primary	Medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit	The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit by means of an adjusted survey.	10 minutes
Primary	Reduced access to medical and psychological help	The occurrence of reduced access to medical and psychological help by means of an adjusted survey.	10 minutes