Effect of Culturally Tailored Nurse-Led Holistic Spiritual Care on Hemodynamic Stability and Well-Being in Preoperative Cardiac Surgery Patients in South Sumatra, Indonesia: A Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure (mmHg)
研究概览
简要总结
This study aims to evaluate the effectiveness of culturally tailored nurse-led holistic spiritual care in improving hemodynamic stability and psychological well-being among patients undergoing preoperative cardiac surgery in South Sumatra, Indonesia.
Preoperative anxiety is common among cardiac surgery patients and can lead to increased blood pressure, heart rate, and overall physiological instability. In addition, psychological distress may negatively affect patient recovery and well-being.
This multi-center randomized controlled trial involves adult patients scheduled for elective cardiac surgery. Participants are randomly assigned to either an intervention group or a control group. The intervention group receives a 20-minute session of culturally tailored holistic spiritual care, including therapeutic communication, deep breathing, progressive muscle relaxation, spiritual reflection, and culturally appropriate prayer. The control group receives standard preoperative care.
Primary outcomes include changes in hemodynamic parameters such as blood pressure, heart rate, and mean arterial pressure. Psychological well-being is assessed using the WHO-5 Well-Being Index.
The results of this study are expected to provide evidence on the effectiveness of integrating culturally responsive spiritual care into routine preoperative nursing practice to improve both physiological and psychological outcomes.
详细描述
Cardiovascular diseases remain a leading cause of morbidity and mortality worldwide, with an increasing number of patients requiring cardiac surgical procedures such as coronary artery bypass grafting and valve surgery. Preoperative anxiety is highly prevalent among cardiac surgery patients and is associated with adverse physiological responses, including increased blood pressure, elevated heart rate, and hemodynamic instability, which may negatively affect perioperative outcomes.
Holistic nursing care, particularly spiritual care, has been recognized as an important approach to address both physiological and psychological needs of patients. Spiritual care interventions, including relaxation techniques, therapeutic communication, and prayer, have demonstrated potential in reducing anxiety and promoting emotional well-being. However, existing evidence remains limited, particularly in multi-center randomized controlled trials and in culturally diverse populations.
This study is a multi-center randomized controlled trial conducted in two tertiary hospitals in South Sumatra, Indonesia. The study aims to evaluate the effectiveness of culturally tailored nurse-led holistic spiritual care in improving hemodynamic stability and psychological well-being among patients undergoing preoperative cardiac surgery.
Participants are randomly assigned to either an intervention group or a control group. The intervention consists of a structured 20-minute session delivered by trained nurses prior to surgery, incorporating therapeutic communication, guided deep breathing, progressive muscle relaxation, spiritual reflection, and culturally adapted prayer based on patients' beliefs and cultural background. The control group receives standard preoperative care without structured spiritual intervention.
The study evaluates both physiological and psychological outcomes. Hemodynamic parameters, including systolic and diastolic blood pressure, heart rate, and mean arterial pressure, are measured before and after the intervention. Psychological well-being is assessed using a validated instrument.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective cardiac surgery
- •Age 18-65 years
- •Conscious and able to communicate effectively
- •Able to understand and provide informed consent
- •Hemodynamically stable prior to intervention
- •Willing to participate in the study
排除标准
- •Patients scheduled for elective cardiac surgery
- •Age 18-65 years
- •Conscious and able to communicate effectively
- •Able to understand and provide informed consent
- •Hemodynamically stable prior to intervention
- •Willing to participate in the study
研究组 & 干预措施
Culturally Tailored Nurse-Led Holistic Spiritual Care
Participants receive a culturally tailored nurse-led holistic spiritual care intervention delivered approximately one hour before surgery. The intervention lasts about 20 minutes and includes therapeutic communication, guided deep breathing, progressive muscle relaxation, spiritual reflection, and culturally adapted prayer based on the patient's beliefs. The intervention is delivered by trained cardiac nurses in a quiet preoperative setting.
干预措施: Culturally Tailored Nurse-Led Holistic Spiritual Care (Behavioral)
Standard Preoperative Care
Participants receive routine preoperative care according to hospital protocols, including standard nursing assessment, preoperative education, monitoring, and surgical preparation. No structured spiritual care or relaxation intervention is provided.
结局指标
主要结局
Systolic Blood Pressure (mmHg)
时间窗: Measured at baseline (pre-intervention) and immediately after the intervention.
Systolic blood pressure will be measured using calibrated bedside monitors to assess changes in hemodynamic status following the intervention.
Diastolic Blood Pressure (mmHg)
时间窗: Measured at baseline (pre-intervention) and immediately after the intervention.
Diastolic blood pressure will be measured using calibrated bedside monitors to evaluate vascular resistance and hemodynamic response to the intervention.
Heart Rate (beats per minute)
时间窗: Measured at baseline (pre-intervention) and immediately after the intervention.
Heart rate will be measured using calibrated bedside monitors to assess autonomic and cardiovascular response to the intervention.
Mean Arterial Pressure (mmHg)
时间窗: Measured at baseline (pre-intervention) and immediately after the intervention.
Mean arterial pressure (MAP) will be measured or calculated using bedside monitoring systems to evaluate overall tissue perfusion and hemodynamic stability.
次要结局
- Psychological Well-Being Score(Measured at baseline (pre-intervention) and immediately after the intervention (preoperative period).)
研究者
Aris Citra Wisuda
Principal Investigator
Lincoln University College Malaysia