NCT07557082

Brief Summary

Introduction: Falls are the most frequently reported and preventable type of safety incident. Patient falls are the most common adverse events in hospitals. This situation impacts clinical outcomes and increases the financial burden on healthcare systems. Simulation is an important component of nursing education because it enhances patient care and ensures patient safety. Objective: To comparatively examine the effect of standard patient-based and web-based simulation methods, implemented in addition to the same theoretical education provided to nursing students, on students' knowledge levels regarding fall risk assessment and their fall risk assessment skills in clinical practice. Materials and Methods: The study was conducted during the spring semester of the 2025-2026 academic year with first-year students in the Department of Nursing at Aydın Adnan Menderes University as part of the Fundamentals of Nursing course. All participating students will complete theoretical classes in the classroom and practical sessions in the laboratory. The study using standard patient and web-based simulation applications will be conducted in the simulation laboratory of the Faculty of Nursing at Aydın Adnan Menderes University. Research data will be collected using the "Individual Information Form," the "Fall Knowledge Test for Preventing Patient Falls" prepared in accordance with the literature, and the "Fall Risk Assessment Skills Rubric." Research data will be collected over a 4-month period (February 9 - June 9, 2026). A written permission letter will be obtained from the institution to conduct the study. Participants will be provided with detailed information about the study, and both verbal and written consent will be obtained. For numerically measured data, a normal distribution analysis will be performed; based on the results of this analysis, "Pearson Chi-square" and "t-tests" will be used for variables showing a normal distribution. Findings: The research findings will be presented based on the analyses conducted. Conclusion: The results will be presented based on the research findings, and recommendations will be made accordingly.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress24%
Apr 2026Jun 2026

First Submitted

Initial submission to the registry

April 23, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

April 27, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2026

Expected
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2026

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

25 days

First QC Date

April 23, 2026

Last Update Submit

April 23, 2026

Conditions

Keywords

web-based simulationstandard patientnursing studentsrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Planned Mean Change in Total Knowledge Score on the Fall Prevention Knowledge Test (0-28)

    Planned Mean Change in Total Knowledge Score on the Fall Prevention Knowledge Test (0-28) Total knowledge score will be measured using the Fall Prevention Knowledge Test among nursing students. Change from baseline will be assessed.

    From enrollment to the 8th week of the intervention.

Secondary Outcomes (4)

  • Planned Mean Change in Total Knowledge Score on the Patient Fall Prevention Knowledge Test

    Immediately after the intervention]

  • Fall Risk Assessment Skills Rubric

    Four weeks after the procedure

  • Planned Mean Change in Student Satisfaction Score Regarding the Simulation Experience

    Immediately after the intervention

  • Planned Mean Change in Learning Self-Confidence Score Regarding the Simulation Experience

    Immediately after the intervention

Study Arms (3)

Group 1 Group trained with a standard patient in the simulation lab

EXPERIMENTAL
Other: Standardized patient

Group 2 The group is receiving web-based simulation training in a laboratory setting.

EXPERIMENTAL
Other: web-based simulation

Group 3 Classical classroom education group.

NO INTERVENTION

Interventions

The group receiving training with standard patients in a simulation laboratory environment.

Group 1 Group trained with a standard patient in the simulation lab

Group receiving training through web-based simulation in a laboratory environment.

Group 2 The group is receiving web-based simulation training in a laboratory setting.

Eligibility Criteria

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

You may qualify if:

  • Be a first-year student in the School of Nursing
  • Be willing to participate in the study
  • Have no absences at any point during the study
  • Have completed both theoretical and clinical training
  • Be willing to remain in the study throughout all phases
  • Be a student who is not currently working or has not previously worked as a nurse

You may not qualify if:

  • Be a graduate of a vocational high school for health sciences
  • Be a student admitted through the Foreign Student Exam (YÖS)
  • Be a student who does not wish to participate in the research
  • Be a student who was admitted to the nursing program through the Vertical Transfer Exam (DGS) after graduating from a program offering an associate's degree in a health-related field

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Süleyman Demirel University Eğirdir School of Health Services

Isparta, Eğirdir, 32500, Turkey (Türkiye)

Location

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 23, 2026

First Posted

April 29, 2026

Study Start

April 27, 2026

Primary Completion (Estimated)

May 22, 2026

Study Completion (Estimated)

June 12, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

This study does not plan to share raw data at the individual level. However, to promote transparency of research findings, summary data (demographic characteristics, pretest and posttest scores, group comparisons, and analysis results) that do not include participant identification will be shared with researchers upon request. No personal identifying information (name, contact information, institutional information, etc.) will be shared.

Shared Documents
SAP, ICF, CSR
Time Frame
August 2026-December 2026
Access Criteria
Access to data will be available only after a written request from the researcher and a review by the research team for scientific relevance. Access will only be provided by securely transmitting designated datasets via email; no sharing will be made via any open-access repository or online platform.

Locations