Simulation TrainingNCT06454786
The Effect of Simulation Method on Self-Confidence and Stress Levels in Nursing Students
A study testing Simulation Method in people with Simulation Training and Nursing Student, run by Seher Yurt at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the impact of training provided through simulation method on self-confidence and stress levels in nursing students during patient intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Simulation Training, Nursing Student, Self Confidence
- What is being tested?
- Simulation Method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2024to 20 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Volunteering to participate in the research, being a senior nursing student
Who cannot join
- Not participating in any simulation training
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Kent University
Istanbul, Kağıthane, 34406
Seher YURT, P.hD
Zahide AKSOY, Msc
About this study
Official title: The Effect of Training Given by Simulation Method on the Self-confidence and Stress Levels of Nursing Students in Patient Intervention
The aim of this study was to determine the impact of training provided through simulation method on self-confidence and stress levels in nursing students during patient intervention.
Read the detailed description
Improving nursing students' clinical skills and enhancing their professional competencies by increasing their patient intervention skills and strengthening their ability to cope with stress is crucial. High professional confidence among nursing students is fundamental to providing effective patient care, which is critical for patient safety and satisfaction. Simulation training is an effective tool used to enhance nursing students' practical experiences in clinical settings. This method provides students with the opportunity to encounter real-life scenarios in a controlled environment and intervene in these situations. Additionally, simulation training can help develop coping skills for dealing with stress, as it prepares students for situations they may encounter in real clinical settings. The aim of this study is to determine the impact of training provided through simulation method on self-confidence and stress levels in nursing students during patient intervention.
The students included in the study will be divided into experimental and control groups through full randomization. The Student Identification Form will be administered to both groups initially. The theoretical part of Shock Nursing Care (SNC) training will be provided to the control group through in-class face-to-face education. Following the theoretical training, skills training will be conducted in the nursing skills laboratory using the demonstration method. Students will be evaluated using the Self-Confidence/Competence in Patient Intervention Scale and the Perceived Stress Scale before and after the training. The study group will receive theoretical education similarly to the control group through in-class face-to-face education. Following the theoretical education, simulation training will be conducted in the Simulation Laboratory based on the SNC Scenario. Simulation training will be conducted in groups of 10, consisting of 5 students each. Each student will be provided the SNC scenario to practice. Students will be evaluated using the Self-Confidence/Competence in Patient Intervention Scale and the Perceived Stress Scale before and after the training. The mean scores of both groups on the Self-Confidence/Competence in Patient Intervention Scale and the Perceived Stress Scale will be compared both between and within groups. Pre-graduation nursing simulation education will contribute to enhancing students' patient intervention skills and stress coping abilities.
- Conditions
- Simulation Training, Nursing Student, Self Confidence, Stress
- Being tested
- Simulation Method
- Keywords
- Simulation Training, Nursing Student, Self Confidence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation MethodOther
Management of cardiogenic shock scenario on an advanced simulation mannequin
| Study group | Role | What they receive |
|---|---|---|
| simülation intervention group | Experimental | The Student Diagnosis Form, Self-Confidence/Efficacy Scale in Patient Intervention and Perceived Stress Scale will be applied first to this group. Then, face-to-face theoretical training will be given. Following the theoretical training, simulation training will be given in the Simulation Laboratory in line with the Nursing Care Scenario in Cardiogenic Shock. Simulation training will be conducted in 10 groups of 5 people and will be completed in 2 days. Each student in the group will actively participate in the simulation training within the scope of their role in the scenario. Posttests will be administered to both groups 2 weeks after the simulation training. Receives: Other: Simulation Method |
| Control group | No intervention | The Student Diagnosis Form, Self-Confidence/Efficacy Scale in Patient Intervention and Perceived Stress Scale will be applied first to this group. Then, face-to-face theoretical training will be given. Post-tests will be administered 2 weeks after the theoretical training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Confidence/Efficacy Scale in Patient Intervention
The scale developed for health professional students with scenario-based simulation-based teaching experience includes 18 items and is evaluated according to a 5-point Likert system (1 = Strongly Disagree, 2 = Disagree, 3 = Undecided, 4 = Agree, 5 = Strongly Agree). While a high score means confidence, a low score means lack of self-confidence in students. Therefore, in clinical practice, the highest possible score is 55 and the lowest score is 11.
Measured: Pre-test, post-test (2nd weeks later)
Secondary outcomes (1)
Perceived Stress Scale for Nursing
The scale consists of 29 items and measures perceived stress for nursing.
Measured: Pre-test, post-test (2nd weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start6 Jun 2024
- Primary completion7 Jun 2024
- Study completion20 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Simulation TrainingStudies 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
- Two groups with experimental and control groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seher Yurt
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Kent University
- Responsible party
- Sponsor-investigator, Seher Yurt, Istanbul Kent University
- Investigators
- SEHER YURT, Principal investigator, Istanbul Kent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454786
- Sponsor's protocol ID
- IstanbulKentU-HEM-SY-01
- Status last verified
- Jul 2024
- First submitted
- 6 Jun 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yurt S, Acikgoz G, Aksoy Z, Akgun FS, Demirel A, Karaca O, Okuroglu G. The effect of high-fidelity simulation on nursing students' self-confidence and stress levels during patient intervention: a randomized controlled trial. BMC Med Educ. 2026 Feb 17;26(1):477. doi: 10.1186/s12909-026-08828-1.
PubMed 41703572
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training Given by Simulation Method on the Self-confidence and Stress Levels of Nursing Students in Patient Intervention
- ClinicalTrials.gov ID
- NCT06454786
- Acronym / sponsor ID
- IstanbulKentU-HEM-SY-01
- Conditions
- Simulation Training, Nursing Student, Self Confidence, Stress
- Keywords
- Simulation Training, Nursing Student, Self Confidence, Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Seher YurtUniversity, hospital or other
- Collaborators
- Istanbul Kent University
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 20 Aug 2024 (estimated)
- First posted
- 12 Jun 2024 (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.
The aim of this study was to determine the impact of training provided through simulation method on self-confidence and stress levels in nursing students during patient intervention.
Detailed description
Improving nursing students' clinical skills and enhancing their professional competencies by increasing their patient intervention skills and strengthening their ability to cope with stress is crucial. High professional confidence among nursing students is fundamental to providing effective patient care, which is critical for patient safety and satisfaction. Simulation training is an effective tool used to enhance nursing students' practical experiences in clinical settings. This method provides students with the opportunity to encounter real-life scenarios in a controlled environment and intervene in these situations. Additionally, simulation training can help develop coping skills for dealing with stress, as it prepares students for situations they may encounter in real clinical settings. The aim of this study is to determine the impact of training provided through simulation method on self-confidence and stress levels in nursing students during patient intervention.
The students included in the study will be divided into experimental and control groups through full randomization. The Student Identification Form will be administered to both groups initially. The theoretical part of Shock Nursing Care (SNC) training will be provided to the control group through in-class face-to-face education. Following the theoretical training, skills training will be conducted in the nursing skills laboratory using the demonstration method. Students will be evaluated using the Self-Confidence/Competence in Patient Intervention Scale and the Perceived Stress Scale before and after the training. The study group will receive theoretical education similarly to the control group through in-class face-to-face education. Following the theoretical education, simulation training will be conducted in the Simulation Laboratory based on the SNC Scenario. Simulation training will be conducted in groups of 10, consisting of 5 students each. Each student will be provided the SNC scenario to practice. Students will be evaluated using the Self-Confidence/Competence in Patient Intervention Scale and the Perceived Stress Scale before and after the training. The mean scores of both groups on the Self-Confidence/Competence in Patient Intervention Scale and the Perceived Stress Scale will be compared both between and within groups. Pre-graduation nursing simulation education will contribute to enhancing students' patient intervention skills and stress coping abilities.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups with experimental and control groups
| Arm | Type | Receives |
|---|---|---|
| simülation intervention group | Experimental | Other: Simulation MethodThe Student Diagnosis Form, Self-Confidence/Efficacy Scale in Patient Intervention and Perceived Stress Scale will be applied first to this group. Then, face-to-face theoretical training will be given. Following the theoretical training, simulation training will be given in the Simulation Laboratory in line with the Nursing Care Scenario in Cardiogenic Shock. Simulation training will be conducted in 10 groups of 5 people and will be completed in 2 days. Each student in the group will actively participate in the simulation training within the scope of their role in the scenario. Posttests will be administered to both groups 2 weeks after the simulation training. |
| Control group | No intervention | –The Student Diagnosis Form, Self-Confidence/Efficacy Scale in Patient Intervention and Perceived Stress Scale will be applied first to this group. Then, face-to-face theoretical training will be given. Post-tests will be administered 2 weeks after the theoretical training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteering to participate in the research, being a senior nursing student
Key exclusion criteria (1 listed)
- Not participating in any simulation training
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 |
|---|---|---|
| Simulation MethodManagement of cardiogenic shock scenario on an advanced simulation mannequin | Other | simülation intervention group |
Primary outcome
Self-Confidence/Efficacy Scale in Patient Intervention
Time frame: Pre-test, post-test (2nd weeks later)
The scale developed for health professional students with scenario-based simulation-based teaching experience includes 18 items and is evaluated according to a 5-point Likert system (1 = Strongly Disagree, 2 = Disagree, 3 = Undecided, 4 = Agree, 5 = Strongly Agree). While a high score means confidence, a low score means lack of self-confidence in students. Therefore, in clinical practice, the highest possible score is 55 and the lowest score is 11.
1 secondary outcome
Perceived Stress Scale for Nursing
Time frame: Pre-test, post-test (2nd weeks later)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 41703572Yurt S, Acikgoz G, Aksoy Z, Akgun FS, Demirel A, Karaca O, Okuroglu G. The effect of high-fidelity simulation on nursing students' self-confidence and stress levels during patient intervention: a randomized controlled trial. BMC Med Educ. 2026 Feb 17;26(1):477. doi: 10.1186/s12909-026-08828-1.
- 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. This study is not recruiting at the moment.
SEHER YURT principal investigator
Istanbul Kent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation Method in people with Simulation Training and Nursing Student, run by Seher Yurt 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SEHER YURT, Ph.D (05325968112, seher.yurt@kent.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Confidence/Efficacy Scale in Patient Intervention (time frame: Pre-test, post-test (2nd weeks later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06454786, which also lists 1 linked publication.
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 30 Jul 2024.