Culturally Tailored Nurse-Led Holistic Spiritual Care Improves Hemodynamic Stability and Well-Being in Cardiac Surgery Patients (CARE-Cardiac)

April 16, 2026 updated by: Aris Citra Wisuda, Lincoln University College Malaysia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

248

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • South Sumatra
      • Palembang, South Sumatra, Indonesia, 30152
        • Siti Fatimah Regional General Hospital, South Sumatra Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Culturally Tailored Nurse-Led Holistic Spiritual Care
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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic Blood Pressure (mmHg)
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.
Measured at baseline (pre-intervention) and immediately after the intervention.
Diastolic Blood Pressure (mmHg)
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.
Measured at baseline (pre-intervention) and immediately after the intervention.
Heart Rate (beats per minute)
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.
Measured at baseline (pre-intervention) and immediately after the intervention.
Mean Arterial Pressure (mmHg)
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.
Measured at baseline (pre-intervention) and immediately after the intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological Well-Being Score
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.
Measured at baseline (pre-intervention) and immediately after the intervention (preoperative period).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lincoln University College Malaysia

Investigators

  • Principal Investigator: Aris Citra Wisuda, PhD, Lincoln University College Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2025

Primary Completion (Actual)

March 12, 2026

Study Completion (Actual)

March 12, 2026

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACW-RCT-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be publicly shared due to ethical and confidentiality considerations. However, de-identified data may be made available from the corresponding author upon reasonable request, subject to approval by the institutional ethics committee.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Surgery

Clinical Trials on Culturally Tailored Nurse-Led Holistic Spiritual Care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe