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临床试验/NCT04406181
NCT04406181Unknown不适用

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 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年5月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Reduced access to medical and psychological help

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

研究组 & 干预措施

operation deferred

Other

Adult patients whose operation date has been deferred due to the pandemic

干预措施: HADS (Behavioral)

operation deferred

Other

Adult patients whose operation date has been deferred due to the pandemic

干预措施: a survey (Behavioral)

no operation date

Other

Patients who did not have had an operation date and who were told to need cardiac surgery before the pandemic started

干预措施: HADS (Behavioral)

no operation date

Other

Patients who did not have had an operation date and who were told to need cardiac surgery before the pandemic started

干预措施: a survey (Behavioral)

postoperative consultation deferred

Other

Patients who have been operating on during the month before the pandemic

干预措施: HADS (Behavioral)

postoperative consultation deferred

Other

Patients who have been operating on during the month before the pandemic

干预措施: a survey (Behavioral)

结局指标

主要结局

Reduced access to medical and psychological help

时间窗: 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)

时间窗: 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

时间窗: 10 minutes

The incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit by means of an adjusted survey.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Veerle Van Mossevelde

Data Nurse

Universitair Ziekenhuis Brussel

研究点 (1)

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