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Not yet recruitingNCT07927855Updated Nov 10, 2026

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

An interventional study of Simulation in Simulation Based Learning, Nursing Students and Knowledge, sponsored by Lokman Hekim University. Not yet recruiting. Open to participants aged Up to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Lokman Hekim University · Not applicable, Interventional, and Supportive care

Updated Nov 10, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
Up to 40 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Simulation Based Learning
  • Nursing Students
  • Knowledge
  • Skill Performance
  • Self-Efficacy
  • Self-Confidence
  • Satisfaction

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03

In context

Personal Satisfaction

541 studies on the registry are indexed under Personal Satisfaction; 93 are open to participants now.

This study's planned enrollment of 34 is below the median of 93 across 416 interventional studies indexed under Personal Satisfaction.

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Lead sponsor

Lokman Hekim University is the lead sponsor of 43 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Being a final-year nursing student

Exclusion criteria

Exclusion Criteria:

  • Having a failed course that will affect graduation
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (estimated)

Study arms

  • Experimental
    Simulation Group

    Other: Simulation

Interventions

  • OtherSimulation

    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.

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What researchers measure

Primary outcomes

  1. Knowledge of VAP Prevention

    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.

    Time frame: Before the educational intervention and immediately after the theoretical education.

  2. Students' Self-Efficacy/competence

    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.

    Time frame: Before the educational intervention and immediately after the simulation and debriefing session.

  3. Student Satisfaction with Learning and Self-Confidence in Learning

    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.

    Time frame: Before the educational intervention and immediately after the simulation and debriefing session.

  4. Performance in Applying the H-ER-O-S VAP Prevention Care Bundle

    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.

    Time frame: During the 15-minute individual simulation scenario

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07927855
Lead sponsor
Lokman Hekim University
Responsible party
Mujde CALIKUSU INCEKAR (Lokman Hekim University, Lokman Hekim University) — Principal investigator
First posted
Nov 10, 2026
Start date
Nov 13, 2026 (estimated)
Primary completion
Jan 30, 2027 (estimated)
Completion
Jan 30, 2027 (estimated)
Last update
Nov 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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