- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07528989
Nurse Navigation Programs Affect to Anxiety, Perception of Quality Nursing Care and Stress Hormone Levels
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nilüfer
-
Bursa, Nilüfer, Turkey (Türkiye), 16000
- Zeynep Gürer
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
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
Sponsor
Collaborators
Investigators
- Study Director: Neriman Akansel, professor, faculty member
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20212411
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Preoperative Anxiety
-
KU LeuvenCompletedPreoperative Anxiety | Preoperative CareBelgium
-
Sunnybrook Health Sciences CentreRecruiting
-
Cairo UniversityNot yet recruitingPreoperative Anxiety | Preoperative Anxiety Experienced by the Pediatric PatientEgypt
-
Sin Lun CHANRecruitingPreoperative AnxietyHong Kong
-
Naime YalçınEnrolling by invitationPreoperative Anxiety | Eosinophil Blood Count | STAI | Preoperative EvaluationTurkey
-
Jia-Ling WangNot yet recruiting
-
Kanuni Sultan Suleyman Training and Research HospitalRecruitingPreoperative AnxietyTurkey (Türkiye)
-
Institut Ophtalmologique de l'Ouest Jules VerneNantes UniversityCompletedPreoperative Anxiety | Virtual RealityFrance
-
Bingol UniversityActive, not recruitingCesarean Section | Preoperative AnxietyTurkey (Türkiye)
-
Mehmet Burak EşkinRecruitingPediatric Preoperative AnxietyTurkey (Türkiye)
Clinical Trials on Nursing navigation program
-
Selcuk UniversityEnrolling by invitation
-
Mehtap GümüşayCompletedQuality of Life | Nursing Caries | Surgical MenopauseTurkey
-
National Taiwan University HospitalCompleted
-
Beni-Suef UniversityBenha UniversityCompletedSickle Cell Disease | Hemoglobinopathies | Thalassemia | Nurse's RoleEgypt
-
University of WashingtonNational Institute of Nursing Research (NINR)Completed
-
University of ZurichCompletedCystic FibrosisSwitzerland
-
The First Affiliated Hospital of Soochow UniversityRecruiting
-
TURKAN OZDASEnrolling by invitation
-
Helwan UniversityCompletedBiomedical Waste Management | Empowering Nursing CompetenceEgypt