NCT07435233

Brief Summary

To compare the impact of simulation practices using a high-reality simulator, hybrid simulator and task-trainers on tracheal aspiration levels of nursing students' knowledge, skills, satisfaction, and self-confidence.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress39%
Jan 2026Mar 2027

Study Start

First participant enrolled

January 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2027

Expected
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

February 20, 2026

Last Update Submit

February 20, 2026

Conditions

Keywords

Nursing educationsimulation technicstracheal aspiration

Outcome Measures

Primary Outcomes (3)

  • Tracheal Aspiration Knowledge Test

    How do different simulation methods affect students' knowledge levels regarding tracheal aspiration procedure? The Tracheal Aspiration Knowledge Test is a 20-item assessment tool developed by researchers based on the literature.

    before the intervention, immediately after the intervention, and at a two-week follow-up

  • Tracheal Aspiration Skill Checklist

    Is there a significant difference in students' tracheal aspiration skill levels between applications performed with a high-fidelity simulator, a hybrid simulator, and a skill dummy? The Tracheal Aspiration Skills Checklist consists of three sections: pre-aspiration, implementation, and post-procedure evaluation. Each step is scored as "performed correctly" (2 points), "performed incompletely/incorrectly" (1 point), or "not performed" (0 points).

    before the intervention, immediately after the intervention, and at a two-week follow-up

  • Student Satisfaction and Self-Confidence in Learning Scale

    How do different simulation methods affect students' satisfaction and self-confidence levels regarding tracheal aspiration procedures? This scale measures students' satisfaction and self-confidence in learning within a simulation environment. It consists of a total of 12 items. Each item is rated on a five-point Likert scale, where 1 represents the lowest score and 5 represents the highest score.

    before the intervention, immediately after the intervention, and at a two-week follow-up

Secondary Outcomes (1)

  • Simulation Design Scale

    immediately after the intervention

Study Arms (3)

Experimental: Group 1: High-Fidelity Simulation Group

EXPERIMENTAL

Experimental Group 1 (High-Fidelity Simulation Group): Nursing students in this group will receive training using a high-fidelity (high-reality) simulator. The simulation scenario will be conducted in a fully immersive environment designed to closely replicate clinical conditions.

Other: High-Fidelity Simulation

Experimental: Group 2: Hybrid Simulation Group

EXPERIMENTAL

Experimental Group 2 (Hybrid Simulation Group): Nursing students in this group will be trained using a hybrid simulation model that combines simulation-based applications with additional instructional components.

Other: Hybrid Simulation

Control Group: Routine Skills Training Group

OTHER

Control Group (Routine Skills Training Group): Students in the control group will receive traditional skills training using a standard skills mannequin as part of routine laboratory practice.

Other: Training mannequin

Interventions

It is life-sized and allows for the application of different patient scenarios, simulating eye blinking, pupil reaction, speech sounds, normal and abnormal respiratory and heart sounds, enabling the measurement of normal and abnormal vital signs (oxygen saturation, respiration, pulse, blood pressure, body temperature), allowing for peripheral venous catheterization and bladder catheterization, featuring movable head and chin, a flexible mouth structure for insertion of the endotracheal tube, and facilitating aspiration procedures.

Experimental: Group 1: High-Fidelity Simulation Group

This technique is based on simulating the intermediate devices used in diagnosis and treatment, rather than simulating the human body itself. In patient diagnosis and treatment, values are monitored on a patient monitor, sounds from various parts of the body are listened to with a stethoscope, and other procedures are performed using similar intermediate devices. Therefore, simulating these intermediate devices provides a similar simulation experience.

Experimental: Group 2: Hybrid Simulation Group

The skills mannequin is a life-size, training simulation dummy routinely used in laboratory classes. It allows for the step-by-step performance of tracheal aspiration (TA), features a flexible mouth structure enabling insertion of an endotracheal tube, and can simulate normal/abnormal breathing and heart sounds. It also has features supporting the measurement of vital signs such as oxygen saturation, respiration, pulse, blood pressure, and body temperature.

Control Group: Routine Skills Training Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being a first-year nursing student and currently continuing education,
  • Having attended the tracheal aspiration (TA) theoretical and laboratory training provided within the scope of this study,
  • Agreeing to participate in the study.

You may not qualify if:

  • Not having attended the TA theoretical and laboratory training provided within the scope of this study,
  • Having prior educational experience related to basic nursing skills,
  • Currently studying in or having graduated from a vocational health high school or any health-related high school, associate, or undergraduate program,
  • Refusing to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karadeniz Technical University

Trabzon, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
To ensure objective evaluation, investigators, selected solely for monitoring purposes and excluded from the randomization process, will administer the pre-test, post-test, and retention tests. For blinding purposes, the observer will not know which group the student being monitored belongs to.
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

February 20, 2026

First Posted

February 27, 2026

Study Start

January 1, 2026

Primary Completion

May 5, 2026

Study Completion (Estimated)

March 5, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations