Nurse Navigation Programs Affect to Anxiety, Perception of Quality Nursing Care and Stress Hormone Levels

April 28, 2026 updated by: Zeynep Gürer, Uludag University

The Effect of a Nurse-led Preoperative Navigation Program on Anxiety, Perceived Quality of Perioperative Nursing Care, and Stress Hormone Levels in Patients Undergoing Coronary Artery Bypass Graft Surgery: A Randomized Controlled Trial

This study aims to evaluate the effect of a nurse-led preoperative navigation program on preoperative anxiety, perceived quality of perioperative nursing care, and serum cortisol levels in patients undergoing coronary artery bypass graft (CABG) surgery. A total of 60 patients scheduled for CABG surgery will be recruited from the cardiovascular surgery clinic and randomly assigned to either the intervention group (n=30) or the control group (n=30). Patients in the intervention group will receive a structured nurse-led preoperative navigation program, including verbal education and an animated video about the surgical and operating room process. Patients in the control group will receive standard perioperative care. Preoperative anxiety, serum cortisol and glucose levels, and perceived quality of perioperative nursing care will be assessed at specified time points.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is designed as a randomized controlled trial to evaluate the effect of a nurse-led preoperative navigation program in patients undergoing coronary artery bypass graft (CABG) surgery. Participants in the intervention group (n=30) will receive a structured nurse-led preoperative navigation program delivered approximately 7 days prior to surgery. The program includes verbal education about the surgical process and operating room procedures, along with an educational animated video that can be viewed repeatedly until the day of surgery. Participants in the control group (n=30) will receive standard perioperative care without the structured navigation program. Participants will be randomly assigned to either the intervention or control group. Outcome measures will be assessed at predefined time points.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • • who is 18 years of age or older

    • Planned to undergo elective coronary artery bypass graft surgery,

    • Who agrees to participate in the research,

      • Whose cognitive functions are in place

    • Communicable • Able to speak and understand Turkish,

Exclusion Criteria:

  • Undergoing emergency surgery

    • Who cannot speak and understand Turkish
    • Having a psychiatric diagnosis

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nursing navigation program
Participants in the intervention group will receive a structured nurse-led preoperative navigation program. After admission to the cardiovascular surgery clinic, patients will receive verbal information about the surgical process and operating room procedures. In addition, an educational animated video will be provided and can be viewed repeatedly until the day of surgery. The intervention will be delivered approximately 7 days prior to surgery.
Other: Nursing navigation program

Participants will receive a structured nurse-led preoperative navigation program delivered approximately 7 days prior to surgery. The program consists of verbal counselling provided by the researcher about the surgical process and operating room procedures, along with an educational animated video designed to explain the perioperative process in a clear and patient-friendly manner.

The animated video (9 minutes and 56 seconds) includes information on the purpose of coronary artery bypass graft surgery, preoperative preparation, transfer to the operating room, the operating room environment and surgical team, and postoperative care in the intensive care unit. The video will be made available to patients and/or their relatives and can be viewed repeatedly until the day of surgery.
No Intervention: Control
Participants in the control group will receive standard perioperative care according to routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: At hospital admission and again 1 day before surgery
Preoperative anxiety was measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The scale consists of 6 items rated on a 5-point Likert scale from 1 (not at all) to 5 (extremely). The total score ranges from 6 to 30, with higher scores indicating higher levels of anxiety.
At hospital admission and again 1 day before surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived Quality of Perioperative Nursing Care
Time Frame: Postoperative day 3
Perceived quality of perioperative nursing care was measured using the Good Perioperative Nursing Care Scale (GPNCS). The Turkish version of the scale consists of 32 items rated on a Likert-type scale from 0 to 5. The total score ranges from 0 to 160, with higher scores indicating better perceived quality of perioperative nursing care.
Postoperative day 3
Serum Cortisol
Time Frame: The day before surgery and the morning of surgery
Serum cortisol levels were measured from fasting blood samples collected in the morning under standardized conditions (before mobilization and getting out of bed). Samples will be analyzed using electrochemiluminescence immunoassay (ECLIA), and results will be reported in µg/dL.
The day before surgery and the morning of surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uludag University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bursa City Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Neriman Akansel, professor, faculty member

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20212411

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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