Patient SafetyNCT07557082
THE EFFECT OF STANDARD PATİENT-BASED AND WEB-BASED SİMULATİON ON NURSİNG STUDENTS' KNOWLEDGE AND CLİNİCAL SKİLLS İN FALL RİSK ASSESSMENT
A study testing Standardized patient and web-based simulation in people with Patient Safety and Fall, run by ESRA ERTUĞRUL at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Safety, Fall, Simulation Edication
- What is being tested?
- Standardized patient and web-based simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Apr 2026to 12 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Süleyman Demirel University Eğirdir School of Health Services
Isparta, Eğirdir, 32500
About this study
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.
Read more
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.
- Conditions
- Patient Safety, Fall, Simulation Edication
- Being tested
- Standardized patient, web-based simulation
- Keywords
- web-based simulation, standard patient, nursing students, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized patientOther
The group receiving training with standard patients in a simulation laboratory environment.
web-based simulationOther
Group receiving training through web-based simulation in a laboratory environment.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Group trained with a standard patient in the simulation lab | Experimental | Not described Receives: Other: Standardized patient |
| Group 2 The group is receiving web-based simulation training in a laboratory setting. | Experimental | Not described Receives: Other: web-based simulation |
| Group 3 Classical classroom education group. | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The change in the total knowledge scores of nursing students will be measured using the Patient Fall Prevention Knowledge Test. Change from baseline will be assessed.
Measured: Immediately after the intervention]
Fall Risk Assessment Skills Rubric
A Fall Risk Assessment Skills Rubric for Clinical Practice has been developed. The rubric consists of 10 items designed to assess students' clinical reasoning, observation, and decision-making skills, independent of any specific scale, with each item scored on a scale of 0-2. The total score ranges from 0 to 20.
Measured: Four weeks after the procedure
Planned Mean Change in Student Satisfaction Score Regarding the Simulation Experience
The change in the average satisfaction score of nursing students in the experimental group will be measured using the Student Satisfaction Scale. Change from baseline will be assessed.
Measured: Immediately after the intervention
Planned Mean Change in Learning Self-Confidence Score Regarding the Simulation Experience
The average learning self-confidence score of nursing students in the experimental group will be measured using the Learning Confidence Scale. Change from baseline will be assessed.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start27 Apr 2026 (estimated)
- Primary completion22 May 2026 (estimated)
- Study completion12 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ESRA ERTUĞRUL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ESRA ERTUĞRUL, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557082
- Sponsor's protocol ID
- 66
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF STANDARD PATİENT-BASED AND WEB-BASED SİMULATİON ON NURSİNG STUDENTS' KNOWLEDGE AND CLİNİCAL SKİLLS İN FALL RİSK ASSESSMENT
- ClinicalTrials.gov ID
- NCT07557082
- Acronym / sponsor ID
- 66
- Conditions
- Patient Safety, Fall, Simulation Edication
- Keywords
- web-based simulation, standard patient, nursing students, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- ESRA ERTUĞRULUniversity, hospital or other
- Study start
- 27 Apr 2026 (estimated)
- Primary completion
- 22 May 2026 (estimated)
- Study completion
- 12 Jun 2026 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized patientThe group receiving training with standard patients in a simulation laboratory environment. | Other | Group 1 Group trained with a standard patient in the simulation lab |
| web-based simulationGroup receiving training through web-based simulation in a laboratory environment. | Other | Group 2 The group is receiving web-based simulation training in a laboratory setting. |
Primary outcome
Planned Mean Change in Total Knowledge Score on the Fall Prevention Knowledge Test (0-28)
Time frame: From enrollment to the 8th week of the intervention.
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.
4 secondary outcomes
Planned Mean Change in Total Knowledge Score on the Patient Fall Prevention Knowledge Test
Time frame: Immediately after the intervention]
Fall Risk Assessment Skills Rubric
Time frame: Four weeks after the procedure
Planned Mean Change in Student Satisfaction Score Regarding the Simulation Experience
Time frame: Immediately after the intervention
Planned Mean Change in Learning Self-Confidence Score Regarding the Simulation Experience
Time frame: Immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized patient and web-based simulation in people with Patient Safety and Fall, run by ESRA ERTUĞRUL at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ESRA ERTUĞRUL (+9005071053241, esraertugrul3232@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Planned Mean Change in Total Knowledge Score on the Fall Prevention Knowledge Test (0-28) (time frame: From enrollment to the 8th week of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.