NCT04766125已完成不适用
Psychological Factors in Cardiac Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Number of adverse events
研究概览
简要总结
The study investigates the effect of adverse event information on adverse event occurrence in patients undergoing elective cardiac surgery in a two-armed, randomized study. One group will receive standard information about adverse events; the second group will receive a standardised elaboration of the standard information. Hypothesis: Elaborated information about adverse events will increase adverse event occurrence, mediated by expectations and anxiety, and moderated by coping style.
详细描述
If quality assessment indicates that the protocol was not followed adequately, participants will be excluded from data analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18 and older) undergoing elective cardiac surgery at the Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital
排除标准
- •Patients who have previously had cardiac surgery
- •Cardiac surgery with deep hypothermia (<32 degrees Celsius)
- •Acute surgery
- •Patients with psychiatric or neurological disease who are unable to collaborate with the study protocol
- •Patients who do not speak/read Danish
结局指标
主要结局
Number of adverse events
时间窗: Assessed on day four
次要结局
- Occurrence of specific adverse events(Assessed on day four, 30, 90, and 180)
- Intensity of experienced adverse events(Assessed on day four, 30, 90, and 180)
- Number of adverse events(Assessed on day 30, 90, and 180)
- Hospital readmission(Assessed on day 180)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
不适用
Psychological Assessment Before General Anesthesia (VeSPPA2018)AnesthesiaNCT03818464University of Parma100
进行中（未招募）
不适用
A Randomized Clinical Trial to Measure Efficacy of Music on Cardiac Surgery PatientsCardiac SurgeryNCT04551469Massachusetts General Hospital120
已完成
不适用
Preoperative Optimization of Cardiac Valve Patients' ExpectationsCardiac Valve DiseaseNCT04502121Philipps University Marburg Medical Center89
已完成
不适用
Effect on Anxiety in Pediatric Patients; Successful Randomized Controlled TrialAnxietyNCT06427928Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital58
已完成
不适用
How do Patients, Nurses and Physicians Perceive Negative Postoperative Events?HealthyNCT00785096University of Zurich615