Siti Fatimah Regional General Hospital, South Sumatra Province
Palembang, South Sumatra, 30152, Indonesia
NCT Number: NCT07540598
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Palembang, South Sumatra, 30152, Indonesia
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.
This study addresses important gaps in the integration of culturally responsive spiritual care into perioperative nursing practice. The findings are expected to provide evidence for a feasible, non-pharmacological, and culturally appropriate intervention to improve patient outcomes in cardiac surgical settings.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This intervention consists of a culturally tailored nurse-led holistic spiritual care session delivered approximately one hour before surgery. The intervention lasts approximately 20 minutes and is conducted in a quiet preoperative setting. It includes five structured components: (1) therapeutic communication to assess patient concerns and establish rapport, (2) guided deep breathing exercises using slow diaphragmatic techniques, (3) progressive muscle relaxation to reduce physiological tension, (4) spiritual reflection focusing on meaning, hope, and coping, and (5) culturally adapted prayer based on the patient's religious and cultural background. The intervention is delivered by trained cardiac nurses using a standardized protocol to ensure consistency across study sites.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured at baseline (pre-intervention) and immediately after the intervention (preoperative period).
Psychological well-being will be assessed using the World Health Organization-Five Well-Being Index (WHO-5), a validated instrument consisting of five items. The total score ranges from 0 to 25, with higher scores indicating better psychological well-being.
Lincoln University College Malaysia
Other
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
Acronym: CARE-Cardiac
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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