Cardiovascular Diseases (CVD)CARE-CardiacNCT07540598
Culturally Tailored Nurse-Led Holistic Spiritual Care Improves Hemodynamic Stability and Well-Being in Cardiac Surgery Patients
A study testing Culturally Tailored Nurse-Led Holistic Spiritual Care in people with Cardiovascular Diseases (CVD) and Preoperative Anxiety, run by Lincoln University College Malaysia at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiovascular Diseases (CVD), Preoperative Anxiety, Cardiac Surgery
- What is being tested?
- Culturally Tailored Nurse-Led Holistic Spiritual Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteIndonesia
- Study dates
- 9 Oct 2025to 12 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Siti Fatimah Regional General Hospital, South Sumatra Province
Palembang, South Sumatra, 30152
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Culturally Tailored Nurse-Led Holistic Spiritual Care
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Tailored Nurse-Led Holistic Spiritual CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Culturally Tailored Nurse-Led Holistic Spiritual Care | Experimental | 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. Receives: Behavioral: Culturally Tailored Nurse-Led Holistic Spiritual Care |
| Standard Preoperative Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure (mmHg)
Systolic blood pressure will be measured using calibrated bedside monitors to assess changes in hemodynamic status following the intervention.
Measured: Measured at baseline (pre-intervention) and immediately after the intervention.
Diastolic Blood Pressure (mmHg)
Diastolic blood pressure will be measured using calibrated bedside monitors to evaluate vascular resistance and hemodynamic response to the intervention.
Measured: Measured at baseline (pre-intervention) and immediately after the intervention.
Heart Rate (beats per minute)
Heart rate will be measured using calibrated bedside monitors to assess autonomic and cardiovascular response to the intervention.
Measured: Measured at baseline (pre-intervention) and immediately after the intervention.
Mean Arterial Pressure (mmHg)
Mean arterial pressure (MAP) will be measured or calculated using bedside monitoring systems to evaluate overall tissue perfusion and hemodynamic stability.
Measured: Measured at baseline (pre-intervention) and immediately after the intervention.
Secondary outcomes (1)
Psychological Well-Being Score
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: Measured at baseline (pre-intervention) and immediately after the intervention (preoperative period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start9 Oct 2025
- Primary completion12 Mar 2026
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Diseases (CVD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lincoln University College Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aris Citra Wisuda, Lincoln University College Malaysia
- Investigators
- Aris Citra Wisuda, PhD, Principal investigator, Lincoln University College Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540598
- Sponsor's protocol ID
- ACW-RCT-2025
- Acronym
- CARE-Cardiac
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07540598
- Acronym / sponsor ID
- CARE-Cardiac / ACW-RCT-2025
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Lincoln University College MalaysiaUniversity, hospital or other
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturally Tailored Nurse-Led Holistic Spiritual Care | Experimental | Behavioral: Culturally Tailored Nurse-Led Holistic Spiritual CareParticipants 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. |
| Standard Preoperative Care | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally Tailored Nurse-Led Holistic Spiritual CareThis 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. | Behavioural | Culturally Tailored Nurse-Led Holistic Spiritual Care |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Psychological Well-Being Score
Time frame: Measured at baseline (pre-intervention) and immediately after the intervention (preoperative period).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aris Citra Wisuda, PhD principal investigator
Lincoln University College Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Tailored Nurse-Led Holistic Spiritual Care in people with Cardiovascular Diseases (CVD) and Preoperative Anxiety, run by Lincoln University College Malaysia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (mmHg) (time frame: Measured at baseline (pre-intervention) and immediately after the intervention.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.