Evaluating and Predicting Anxiety in Patients Undergoing Elective Coronary Angiography
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
- 否
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)