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

Study Overview
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Brief Summary
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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: The degree of anxiety and/or depression induced by their altered medical care trajectory. The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit The occurrence of reduced access to medical and psychological help

Detailed Description
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A prospective study by means of a questionnaire, specifically designed for each of the three groups. Adult patients whose operation date has been deferred Patients who did not have had an operation date 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.

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

Conditions
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Anxiety and Fear, Anxiety Depression, Anxiety Postoperative, Psychological Stress

Intervention / Treatment
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* Behavioral: HADS
* Behavioral: a survey


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, postoperative consultation, postponed elective surgery, COVID-19