The Effect of Simulation-Based Training on the a Care Bundle to VIP

November 4, 2026 updated by: Mujde CALIKUSU INCEKAR, Lokman Hekim University

The Effect of Simulation-Based Training on a Care Bundle to VIP

Ventilator-associated pneumonia (VAP) is one of the most serious and frequent healthcare-associated infections occurring in premature and low-birth-weight infants in neonatal intensive care units. The literature on VAP prevention strongly indicates that a "care bundle" approach is among the most effective methods for reducing the incidence of this infection.

The objective of this research is to determine the impact of a simulation-based intervention-structured around the "H-ER-O-S care bundle" designed to prevent the development of VAP-on the knowledge, skills, self-efficacy/competence, self-confidence, and satisfaction levels of final-year nursing students.

This study will employ a pretest-posttest experimental design and will be conducted at the Lokman Hekim University Vital Simulation Center, involving 34 final-year nursing students.

As part of the pretest and posttest assessments, students will complete the "Self-Efficacy/Competence Scale", the "Student Satisfaction and Self-Confidence in Learning Scale", and "VAP Test". During the simulation, the students' acquisition of the relevant skills will be evaluated and scored using the "H-ER-O-S Care Bundle Checklist." Data will be recorded anonymously in the SPSS software.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

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 (Estimated)

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.
34

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

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

No older than 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being a final-year nursing student

Exclusion Criteria:

  • Having a failed course that will affect graduation

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: Simulation Group
Other: Simulation

The intervention is a simulation-based educational program on neonatal ventilator-associated pneumonia (VAP) prevention. Students will receive face-to-face theoretical education on VAP and the H-ER-O-S VAP prevention care bundle. A prebriefing session will introduce the simulation objectives, equipment, and scenario. Each student will individually perform a 15-minute simulation scenario after 5 minutes of preparation. Researchers will observe without providing assistance, and performance will be assessed using the H-ER-O-S Care Bundle Checklist. Performances will be video-recorded for debriefing. Immediately after the scenario, students will participate in a 20-30-minute structured debriefing session in groups of 5-6, including video review, reflection, and feedback.

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
Knowledge of VAP Prevention
Time Frame: Before the educational intervention and immediately after the theoretical education.

Students' knowledge regarding ventilator-associated pneumonia (VAP) prevention in neonatal intensive care settings will be assessed using a 10-item multiple-choice knowledge test developed by the researchers based on the literature. Each correct answer will receive 10 point, and incorrect answers will receive 0 points. Total scores will range from 0 to 100, with higher scores indicating greater knowledge.
Before the educational intervention and immediately after the theoretical education.
Students' Self-Efficacy/competence
Time Frame: Before the educational intervention and immediately after the simulation and debriefing session.

Students' self-efficacy will be assessed using the Turkish version of the 23-item Self-Efficacy-competence Scale. Total scores range from 23 to 115, with higher scores indicating greater perceived self-efficacy and competence.
Before the educational intervention and immediately after the simulation and debriefing session.
Student Satisfaction with Learning and Self-Confidence in Learning
Time Frame: Before the educational intervention and immediately after the simulation and debriefing session.

Students' satisfaction with learning and self-confidence in learning will be assessed using the 12-item Turkish version of the Student Satisfaction and Self-Confidence in Learning Scale. The scale includes two subscales: satisfaction with current learning (5 items) and self-confidence in learning (7 items). Higher scores indicate greater satisfaction and self-confidence.
Before the educational intervention and immediately after the simulation and debriefing session.
Performance in Applying the H-ER-O-S VAP Prevention Care Bundle
Time Frame: During the 15-minute individual simulation scenario

Students' performance in applying the H-ER-O-S ventilator-associated pneumonia prevention care bundle will be assessed during individual simulation scenarios using the H-ER-O-S Care Bundle Checklist. Performance will be evaluated by researchers through direct observation of students' actions during the simulation.
During the 15-minute individual simulation scenario

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.
Lokman Hekim University

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 (Estimated)

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 13, 2026

Primary Completion (Estimated)

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.
January 30, 2027

Study Completion (Estimated)

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.
January 30, 2027

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).
November 4, 2026

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.
November 4, 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.
November 10, 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.
November 10, 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.
November 4, 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.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • LHU-MCI-01

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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