NCT07540598

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2026

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

April 9, 2026

Last Update Submit

April 16, 2026

Conditions

Cardiovascular Diseases (CVD)Preoperative AnxietyCardiac Surgery

Outcome Measures

Primary Outcomes (4)

  • Systolic Blood Pressure (mmHg)

    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)

    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)

    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)

    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 Outcomes (1)

  • Psychological Well-Being Score

    Measured at baseline (pre-intervention) and immediately after the intervention (preoperative period).

Study Arms (2)

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.

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.

Interventions

Culturally Tailored Nurse-Led Holistic Spiritual CareBEHAVIORAL

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.

Culturally Tailored Nurse-Led Holistic Spiritual Care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siti Fatimah Regional General Hospital, South Sumatra Province

Palembang, South Sumatra, 30152, Indonesia

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Aris Citra Wisuda, PhD

    Lincoln University College Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 20, 2026

Study Start

October 9, 2025

Primary Completion

March 12, 2026

Study Completion

March 12, 2026

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations

ID(1)