Nurse's RoleNCT07448168
Effect of Standardized Patient Simulation on Nursing Students' Assessment, Diagnosis Skills, and Experiences
A study testing Standardized Patient Simulation-Based Training and Traditional Training in people with Nurse's Role, run by Karadeniz Technical University.
Trial summary
This randomized controlled study aims to determine the effect of teaching delivered through standardized patient simulation on nursing students' assessment and nursing diagnosis determination skills, as well as their learning experiences. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role
- What is being tested?
- Standardized Patient Simulation-Based Training and Traditional Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2026to 15 May 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
- First-year nursing student
- Successfully completed the Fundamentals of Nursing I course
- Currently enrolled in the Fundamentals of Nursing II course
- Aged 18 years or older
- Voluntary agreement to participate in the study
Who cannot join
- Previously completed the Fundamentals of Nursing II course
- Withdrawal from the study for any reason
- Failure to complete the post-test assessment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Teaching With Standardized Patient Simulation on Students' Assessment and Nursing Diagnosis Determination Skills and Determination of Their Experiences
This randomized controlled study aims to determine the effect of teaching delivered through standardized patient simulation on nursing students' assessment and nursing diagnosis determination skills, as well as their learning experiences. First-year nursing students will be randomly assigned to intervention and control groups. The intervention group will receive training based on standardized patient simulation, while the control group will receive traditional instruction. Data will be collected using a sociodemographic information form, case-based assessment tools, and measurement instruments designed to evaluate students' perceptions and experiences related to the educational process. Group comparisons will be conducted to evaluate the effectiveness of the simulation-based teaching method.
Read the detailed description
The nursing process is a fundamental component of the bachelor's degree nursing program and plays a critical role in developing students' skills in systematic data collection, analysis, and nursing diagnosis, particularly during the first year of education. Traditional teaching methods may be insufficient to support the development of clinical reasoning and decision-making skills. Therefore, standardized patient simulation, an active learning strategy, is recognized as an effective approach to holistically develop students' cognitive, psychomotor, and affective competencies.
This randomized controlled trial will be conducted with first-year nursing students. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive education based on standardized patient simulation focusing on the first two steps of the nursing process: nursing assessment and nursing diagnosis. The control group will receive the same theoretical content through traditional teaching methods.
The primary outcome measures of the study are the students' nursing assessment and nursing diagnosis skills. The secondary outcome measure is the students' experiences and perceptions of the educational process. Data will be collected before and after the intervention using appropriate measurement tools. The collected data will be analyzed using appropriate statistical methods to compare the differences.
- Conditions
- Nurse's Role
- Being tested
- Standardized Patient Simulation-Based Training, Traditional Training
- Keywords
- Nursing assessment, Nursing diagnosis, Nursing process, Nursing students, Simulation training, Standardised patient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Patient Simulation-Based TrainingBehavioural
This intervention consists of structured training sessions using standardized patient simulation scenarios. The training focuses on developing students' nursing assessment and nursing diagnosis skills through active participation, scenario-based practice, and evaluation meetings.
Traditional TrainingBehavioural
This intervention consists of traditional lecture and case-based education focused on nursing assessment and nursing diagnosis determination.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Patient Simulation-Based Training Group | Experimental | Participants in this group will receive training based on standardized patient simulation focused on nursing assessment and nursing diagnosis skills. Receives: Behavioral: Standardized Patient Simulation-Based Training |
| Traditional Training Group | Active comparator | Participants in this group will receive traditional training in nursing assessment and determining nursing diagnoses. Receives: Behavioral: Traditional Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nursing Assessment Skill Score
Students' nursing assessment skills will be evaluated using the Nursing Assessment Evaluation Form developed by the researchers. Higher scores indicate better assessment performance.
Measured: Pre-test (baseline) and post-test (after completion of training, approximately 1 week).
Secondary outcomes (1)
Nursing Diagnosis Determination Skill Score
Students' ability to determine accurate nursing diagnoses will be evaluated using a standardized diagnosis evaluation checklist. Higher scores indicate greater diagnostic accuracy.
Measured: Pre-test (baseline) and post-test (after completion of training, approximately 1 week).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start31 Mar 2026 (estimated)
- Primary completion24 Apr 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies 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
- Model description
- Participants will be randomized into simulation and traditional education groups, and outcomes will be compared between groups.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulya Batmaz, Karadeniz Technical University
- Investigators
- Fulya Batmaz, PhD(c), Principal investigator, Karadeniz Technical University, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448168
- Sponsor's protocol ID
- 2025/44
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Teaching With Standardized Patient Simulation on Students' Assessment and Nursing Diagnosis Determination Skills and Determination of Their Experiences
- ClinicalTrials.gov ID
- NCT07448168
- Acronym / sponsor ID
- 2025/44
- Conditions
- Nurse's Role
- Keywords
- Nursing assessment, Nursing diagnosis, Nursing process, Nursing students, Simulation training, Standardised patient
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 24 Apr 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 4 Mar 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.
This randomized controlled study aims to determine the effect of teaching delivered through standardized patient simulation on nursing students' assessment and nursing diagnosis determination skills, as well as their learning experiences. First-year nursing students will be randomly assigned to intervention and control groups. The intervention group will receive training based on standardized patient simulation, while the control group will receive traditional instruction. Data will be collected using a sociodemographic information form, case-based assessment tools, and measurement instruments designed to evaluate students' perceptions and experiences related to the educational process. Group comparisons will be conducted to evaluate the effectiveness of the simulation-based teaching method.
Detailed description
The nursing process is a fundamental component of the bachelor's degree nursing program and plays a critical role in developing students' skills in systematic data collection, analysis, and nursing diagnosis, particularly during the first year of education. Traditional teaching methods may be insufficient to support the development of clinical reasoning and decision-making skills. Therefore, standardized patient simulation, an active learning strategy, is recognized as an effective approach to holistically develop students' cognitive, psychomotor, and affective competencies.
This randomized controlled trial will be conducted with first-year nursing students. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive education based on standardized patient simulation focusing on the first two steps of the nursing process: nursing assessment and nursing diagnosis. The control group will receive the same theoretical content through traditional teaching methods.
The primary outcome measures of the study are the students' nursing assessment and nursing diagnosis skills. The secondary outcome measure is the students' experiences and perceptions of the educational process. Data will be collected before and after the intervention using appropriate measurement tools. The collected data will be analyzed using appropriate statistical methods to compare the differences.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into simulation and traditional education groups, and outcomes will be compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Standardized Patient Simulation-Based Training Group | Experimental | Behavioral: Standardized Patient Simulation-Based TrainingParticipants in this group will receive training based on standardized patient simulation focused on nursing assessment and nursing diagnosis skills. |
| Traditional Training Group | Active comparator | Behavioral: Traditional TrainingParticipants in this group will receive traditional training in nursing assessment and determining nursing diagnoses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First-year nursing student
- Successfully completed the Fundamentals of Nursing I course
- Currently enrolled in the Fundamentals of Nursing II course
- Aged 18 years or older
- Voluntary agreement to participate in the study
Key exclusion criteria (3 listed)
- Previously completed the Fundamentals of Nursing II course
- Withdrawal from the study for any reason
- Failure to complete the post-test assessment
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 Patient Simulation-Based TrainingThis intervention consists of structured training sessions using standardized patient simulation scenarios. The training focuses on developing students' nursing assessment and nursing diagnosis skills through active participation, scenario-based practice, and evaluation meetings. | Behavioural | Standardized Patient Simulation-Based Training Group |
| Traditional TrainingThis intervention consists of traditional lecture and case-based education focused on nursing assessment and nursing diagnosis determination. | Behavioural | Traditional Training Group |
Primary outcome
Nursing Assessment Skill Score
Time frame: Pre-test (baseline) and post-test (after completion of training, approximately 1 week).
Students' nursing assessment skills will be evaluated using the Nursing Assessment Evaluation Form developed by the researchers. Higher scores indicate better assessment performance.
1 secondary outcome
Nursing Diagnosis Determination Skill Score
Time frame: Pre-test (baseline) and post-test (after completion of training, approximately 1 week).
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 4 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Fulya Batmaz, PhD(c) principal investigator
Karadeniz Technical University, Faculty of Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Patient Simulation-Based Training and Traditional Training in people with Nurse's Role, run by Karadeniz Technical University.
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 5 inclusion and 3 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 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Fulya Batmaz, RN, MSc, (+9004623771191, fulya.batmaz@ktu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nursing Assessment Skill Score (time frame: Pre-test (baseline) and post-test (after completion of training, approximately 1 week).). 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 4 Mar 2026.