Effectiveness of a Nursing Intervention for the Preparation and Follow-up of Patients Undergoing Cardiovascular Surgery. Design and Evaluation of a Nursing Educational Program for the Preparation and Follow-up of Patients Undergoing Cardiovascular Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- Anxiety
研究概览
简要总结
Cardiovascular surgery is associated with high levels of anxiety, uncertainty, and postoperative complications. Educational interventions led by nurses may improve patients' psychological adaptation, self-care abilities, and recovery outcomes.
This randomized controlled trial aims to evaluate the effectiveness of a nurse-led educational program designed to prepare and support patients undergoing cardiovascular surgery. Participants are randomly assigned to either an intervention group receiving a structured perioperative educational program or a control group receiving usual care.
The primary outcome is anxiety. Secondary outcomes include posoperative complications, patient satisfaction, pain intensity, length of ICU Stay, length of Hospital Stay, Body Mass Index, blood pressure, fasting blood glucose, Glycated Hemoglobin (HbA1c) and total Cholesterol. Participants are followed for six months after surgery.
详细描述
Patients undergoing cardiovascular surgery frequently experience anxiety and uncertainty before surgery and during postoperative recovery. Adequate preparation and follow-up may improve psychological well-being, promote self-care, and facilitate recovery.
This single-center randomized controlled trial evaluates a nurse-led educational intervention for patients undergoing elective cardiovascular surgery at Hospital Clínic de Barcelona. The intervention includes structured education and follow-up throughout the perioperative period, focusing on preparation for surgery, postoperative recovery, self-care, symptom management, and lifestyle recommendations.
Participants are randomly allocated to either the intervention group or the usual care group. Outcomes are assessed at baseline, during hospitalization, and during follow-up up to six months after surgery.
The primary outcome is anxiety measured using validated assessment instruments. Secondary outcomes include self-efficacy, self-care capacity, health-related quality of life, postoperative complications, hospital readmissions, healthcare utilization, and patient satisfaction.
The study aims to determine whether a structured nurse-led educational program improves psychological, behavioral, and clinical outcomes in patients undergoing cardiovascular surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Adults aged 18 years or older.
- •Patients undergoing first-time cardiac surgery.
- •Ability to understand and communicate in Spanish or Catalan.
- •Provision of written informed consent.
排除标准
- •Refusal or inability to provide informed consent.
- •Previous cardiovascular surgery.
- •Transcatheter aortic valve implantation (TAVI) or other percutaneous procedures.
- •Cardiogenic shock before surgery requiring sedation and endotracheal intubation.
- •Psychiatric disorders requiring treatment, including anxiety disorders, depression, alcoholism, dementia, psychosis, schizophrenia, amnesia, or personality disorders.
- •Severe chronic diseases, including cirrhosis, hepatitis B or C, HIV/AIDS, Parkinson's disease, severe autoimmune disorders, blindness, or severe hearing impairment.
- •Intensive care unit stay longer than 15 days after surgery.
- •Death during hospitalization, including perioperative mortality.
研究组 & 干预措施
Experimental Group
Nurse-Led Educational Intervention
干预措施: Nurse-Led Educational Program (Behavioral)
Control Group
Usual Care
结局指标
主要结局
Anxiety
时间窗: Baseline through 6 months after surgery
Anxiety assessed using the Hospital Anxiety and Depression Scale (HADS). Total HADS scores range from 0 to 42, with higher scores indicating greater emotional distress.
次要结局
- Postoperative Complications(From surgery until 6 months post-surgery)
- Pain Intensity(Hospitalization through 6 months post-surgery)
- Patient Satisfaction(6 months post-surgery)
- Length of ICU Stay(From ICU admission after surgery until ICU discharge during the index hospitalization (up to 15 days after surgery).)
- Length of Hospital Stay(From hospital admission until hospital discharge (up to 30 days after surgery))
- Body Mass Index(Baseline, hospital admission, and 6 months post-surgery)
- Blood Pressure(Baseline, hospital admission, and 6 months post-surgery)
- Fasting Blood Glucose(Baseline, hospital admission, and 6 months post-surgery)
- Glycated Hemoglobin (HbA1c)(Baseline, hospital admission, and 6 months post-surgery)
- Total Cholesterol(Baseline, hospital admission, and 6 months post-surgery)
研究者
Anna Farrús Torrella
Principal Investigator
University of Barcelona