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临床试验/NCT02804009
NCT02804009Unknown不适用

Evaluating and Predicting Anxiety in Patients Undergoing Elective Coronary Angiography

General and Teaching Hospital Celje1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
350
试验地点
1
主要终点
Change between emotional anxiety in patients without depressive symptoms

研究概览

简要总结

Anxiety will be assessed from two aspects, the somatic and emotional. ANGST aims to determine how anxiety correlates with psychological parameters (personality traits, coping strategies and depressive symptoms) and with the outcome of elective coronary angiography (CA).

详细描述

This research is a prospective cross-section study of patients undergoing elective CA. Research design will allow studying anxiety at four timepoints and its correlation with CA outcome and psychological parameters. This study will be conducted at the Coronary care unit of the department of Cardiology, General and Teaching Hospital Celje, Slovenia.

Data regarding prior to CA, during hospital stay and after discharge variables will be collected in order to control for confounding variables when testing the association between anxiety and psychological parameters. All the data needed for this study will be collected within one month from the patient enrollment in this study at four occasions: (1) 14 days prior CA - all patients will receive questionnaires by post, (2) on the day of the admission, 2-4 hours before CA, (3) 24 hours after CA, but prior to discharge and (4) 4-6 weeks after discharge. Clinical and demographical data will be collected from medical records. Data regarding anxiety and other psychological parameters will be assessed using standardized questionnaires. These will be sent to the patient together with covering letter providing instructions to complete the questionnaires 14 days prior CA without help of family members/friends. A month after CA, the questionnaires for anxiety and depressive symptoms will be sent to participants address with reply paid envelope provided.

The Republic of Slovenia National Medical Ethics Committee has approved this study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • invited to elective CA because of suspected/unknown: coronary artery disease, valvular heart disease, heart failure etiology, unexplained arrhythmia, cardiomyopathy etiology;
  • written consent;
  • completed first set of questionnaires 14 days prior to coronary angiography

排除标准

  • need for an urgent coronary angiography,
  • coronary angiography in last 6 months,
  • unable to provide written consent,
  • severe physical and/or mental disease/disability,
  • help needed in completing the questionnaires,
  • unsigned consent form,
  • incomplete first set of questionnaires 14 days prior to coronary angiography.

结局指标

主要结局

Change between emotional anxiety in patients without depressive symptoms

时间窗: Baseline, 2 hours before CA, 24h after CA and 1 month after CA

Measured with Spielberger State Anxiety Inventory

Change between somatic anxiety in patients without depressive symptoms

时间窗: Baseline, 2 hours before CA, 24h after CA and 1 month after CA

Measured with Beck Anxiety Inventory

次要结局

  • Depressive symptoms(Baseline, 1 month after CA)
  • Response on stress(Baseline)
  • Personality traits(Baseline)
  • Trait Anxiety(Baseline)

研究者

发起方
General and Teaching Hospital Celje
申办方类型
Other
责任方
Sponsor

研究点 (1)

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