NCT07528989

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

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

November 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2024

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

May 13, 2024

Last Update Submit

April 28, 2026

Conditions

Keywords

Nurse navigationPreoperative anxietyPerioperative nursing careCoronary artery bypass graftingCortisolRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Anxiety

    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 Outcomes (2)

  • Perceived Quality of Perioperative Nursing Care

    Postoperative day 3

  • Serum Cortisol

    The day before surgery and the morning of surgery

Study Arms (2)

Nursing navigation program

EXPERIMENTAL

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

Control

NO INTERVENTION

Participants in the control group will receive standard perioperative care according to routine clinical practice.

Interventions

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.

Nursing navigation program

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • Undergoing emergency surgery
  • Who cannot speak and understand Turkish
  • Having a psychiatric diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Gürer

Bursa, Nilüfer, 16000, Turkey (Türkiye)

Location

Study Officials

  • Neriman Akansel, professor

    faculty member

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is designed as a randomized controlled trial to evaluate the effect of a nurse-led preoperative navigation program on preoperative anxiety, perceived quality of perioperative nursing care, and serum cortisol and glucose levels in patients undergoing coronary artery bypass graft (CABG) surgery. Participants will be randomly assigned to either the intervention or control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 13, 2024

First Posted

April 14, 2026

Study Start

November 1, 2023

Primary Completion

June 1, 2024

Study Completion

November 1, 2024

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations