Nursing EducationNCT07653308
Effects of NICU Scenario-Based Simulation on Nursing Students' Perceived Stress, Satisfaction, Self-Confidence, and Learning: A Mixed-Methods Study
A study testing NICU Scenario-Based Simulation Training in people with Nursing Education and Simulation Based Learning, run by Atılım University at 1 site in Turkey (Türkiye).
Trial summary
This mixed-methods study examines the effects of neonatal intensive care unit (NICU) scenario-based simulation training on third-year nursing students' perceived stress, learning satisfaction, self-confidence, and simulation-based 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
- Nursing Education, Simulation Based Learning, Stress, Psychological
- What is being tested?
- NICU Scenario-Based Simulation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 May 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
- Third-year undergraduate nursing students at Atılım University Faculty of Health Sciences
- Voluntarily willing to participate and providing written informed consent
- Have not yet completed the Child Health and Diseases (NURS302) course
Who cannot join
- Withdrawal from the study at any stage
- Incomplete completion of data collection forms
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atılım University Faculty of Health Sciences, Department of Nursing Simulation Laboratory
Ankara, 06830
About this study
Official title: The Effect of Neonatal Intensive Care Unit Scenario-Based Simulation Training on Nursing Students' Perceived Stress, Learning Satisfaction, Self-Confidence, and Simulation-Based Learning: A Mixed-Methods Study
This mixed-methods study examines the effects of neonatal intensive care unit (NICU) scenario-based simulation training on third-year nursing students' perceived stress, learning satisfaction, self-confidence, and simulation-based learning experiences. All eligible participants will receive a high-fidelity simulation session involving a NICU scenario that includes therapeutic communication with a postpartum mother, neonatal emergency intervention, and support for mother-infant interaction. The simulation protocol consists of prebriefing (3 minutes), environmental orientation (3 minutes), scenario-based simulation (10 minutes), and debriefing using the PEARLS model (30 minutes). Quantitative data will be collected before and after the simulation using validated scales. Qualitative data will be gathered through semi-structured focus group interviews following the simulation. The study aims to provide evidence on the effectiveness of NICU simulation-based education in nursing training.
Read the detailed description
Neonatal intensive care units (NICUs) are complex clinical environments requiring advanced technical skills, rapid decision-making, teamwork, and effective communication. Nursing students often face significant challenges in these settings, including stress related to patient acuity, fear of making errors, and difficulties in communicating with emotionally vulnerable parents.
This study will be conducted at Atılım University Faculty of Health Sciences, Nursing Skills Laboratory in Ankara, Turkey. Third-year nursing students who have not yet completed the Child Health and Diseases (NURS302) course will be eligible to participate. The entire third-year cohort (n=18) will be invited to participate; no sampling will be applied.
The study employs a parallel mixed-methods design. The quantitative component uses a single-group pre-post quasi-experimental design. The qualitative component involves semi-structured focus group interviews to explore students' simulation experiences in depth.
The NICU simulation scenario includes three interconnected components: initiating therapeutic communication with a postpartum mother whose preterm infant is admitted to the NICU, performing emergency neonatal intervention during an acute event, and supporting the initiation of mother-infant contact and breastfeeding. The scenario was developed in accordance with the Healthcare Simulation Standards of Best Practice™.
Data collection will occur in three phases. In Phase 1, participants will complete the Student Descriptive Information Form and the Perceived Stress Scale for Nursing Students (pre-test). In Phase 2, the simulation and PEARLS-based debriefing will be conducted, followed by post-test administration of the Perceived Stress Scale, Simulation-Based Learning Evaluation Scale, and Student Satisfaction and Self-Confidence in Learning Scale. In Phase 3, semi-structured focus group interviews will be conducted and audio-recorded with participant consent.
Quantitative data will be analyzed using SPSS 29.0. Qualitative data will be analyzed using MAXQDA through thematic coding. Findings from both components will be integrated during the interpretation phase.
- Conditions
- Nursing Education, Simulation Based Learning, Stress, Psychological, Nursing Students, Neonatal Intensive Care
- Being tested
- NICU Scenario-Based Simulation Training
- Keywords
- neonatal intensive care simulation, nursing students, perceived stress, learning satisfaction, self-confidence, simulation-based learning, PEARLS debriefing, mixed methods, NICU nursing education, focus group
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NICU Scenario-Based Simulation TrainingBehavioural
A structured high-fidelity simulation protocol consisting of prebriefing (3 min), environmental orientation (3 min), NICU scenario-based simulation (10 min), and PEARLS model debriefing (30 min). The scenario includes therapeutic communication with a postpartum mother, neonatal emergency intervention, and support for mother-infant interaction and breastfeeding initiation.
| Study group | Role | What they receive |
|---|---|---|
| NICU Simulation Group | Experimental | Third-year nursing students who received a high-fidelity NICU scenario-based simulation training including prebriefing, simulation, and PEARLS-based debriefing phases, followed by semi-structured focus group interviews. Receives: Behavioral: NICU Scenario-Based Simulation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale for Nursing Students Score
Pre- and post-simulation total scores on the Perceived Stress Scale for Nursing Students measuring students' perceived stress levels during clinical training
Measured: Baseline (before simulation) and immediately after debriefing
Simulation-Based Learning Evaluation Scale Score
Post-simulation total score on the Simulation-Based Learning Evaluation Scale measuring nursing process, patient safety, professional knowledge, communication, and reflective behavior
Measured: Immediately after debriefing
Secondary outcomes (2)
Student Satisfaction and Self-Confidence in Learning Scale Score
Post-simulation total score measuring students' satisfaction and self-confidence following simulation-based education
Measured: Immediately after debriefing
Simulation Experience - Qualitative Findings
Themes emerging from semi-structured focus group interviews exploring students' perceptions of stress, self-confidence, communication skills, teamwork, and learning during NICU simulation
Measured: Immediately after debriefing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start18 May 2026
- Primary completion12 Jun 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.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Nursing EducationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atılım University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didem Yüksel, PhD, Principal investigator, Atılım University, Faculty of Health Sciences, Department of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07653308
- Sponsor's protocol ID
- E-59394181-100-137319
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study involves a small sample of nursing students from a single institution, which may increase the risk of participant identification despite de-identification procedures. In addition, the study includes qualitative interview data that may contain information that could potentially compromise participant confidentiality. Only aggregated and anonymized results will be reported in publications and presentations.
Publications
Shi Z, Li X, Hu Y, Yang R, Zeng Z, Hou S. Barriers and facilitators to the implementation of the kangaroo mother care in NICUs of high-income and low- and middle-income countries: a scoping review. Front Public Health. 2026 Jan 12;13:1701738. doi: 10.3389/fpubh.2025.1701738. eCollection 2025.
PubMed 41602019Salifu DA, Christmals CD, Reitsma GM. Frameworks for the design, implementation, and evaluation of simulation-based nursing education: A scoping review. Nurs Health Sci. 2022 Sep;24(3):545-563. doi: 10.1111/nhs.12955. Epub 2022 Jun 6.
PubMed 35596536Masten M, Sommerfeldt S, Gordan S, Greubel E, Canning C, Lioy J, Chuo J. Evaluating Teamwork in the Neonatal Intensive Care Unit: A Survey of Providers and Parents. Adv Neonatal Care. 2019 Aug;19(4):285-293. doi: 10.1097/ANC.0000000000000604.
PubMed 30893093Karaca, A., Yıldırım, N., Ankaralı, H., Açıkgöz, F. ve Akkuş, D. (2015). Hemşirelik Öğrencileri İçin Algılanan Stres, Biyo-Psiko-Sosyal Cevap ve Stresle Başetme Davranışları Ölçeklerinin Türkçe'ye uyarlanması. Psikiyatri Hemşireliği Dergisi, 6(1), 15-25.
Eyikara, E., & Baykara, Z. G. (2017). The Importance of Simulation in Nursing Education. World Journal on Educational Technology: Current Issues, 9(1), 2-7.
Decataldo A, Lauritano G, Paleardi F. The fragile dialogue: communication barriers, authority and adaptive strategies in NICU parent-healthcare worker relationships. Front Sociol. 2025 Nov 26;10:1683833. doi: 10.3389/fsoc.2025.1683833. eCollection 2025.
PubMed 41384238Creswell, J. W., & Plano Clark, V. L. (2018). Designing and conducting mixed methods research (3rd ed.). Sage Publications.
Bry A, Wigert H, Bry K. Need and benefit of communication training for NICU nurses. PEC Innov. 2023 Feb 14;2:100137. doi: 10.1016/j.pecinn.2023.100137. eCollection 2023 Dec.
PubMed 37214501Bilyk, A. (2024). The Lived Experience of Parents with Newborns in the Neonatal Intensive Care Unit (NICU): A Heuristic Inquiry (Doctoral dissertation, Walden University).
Andretta, V., Cerrone, V., Strini, V., & Prendin, A. (2025). Family-centered care in pediatric and neonatal intensive care units: A systematic review. Patient Experience Journal, 12(2), 76-82. https://pxjournal.org/journal/vol12/iss2/14/
Zebreski L, Bloodgood K, Wyble K. Preparing Neonatal Nurses for Improved Performance, Professional Development, and National Certification Through Simulation. Adv Neonatal Care. 2022 Aug 1;22(4):E131-E136. doi: 10.1097/ANC.0000000000000946. Epub 2021 Oct 12.
PubMed 34654046Yousef N, Moreau R, Soghier L. Simulation in neonatal care: towards a change in traditional training? Eur J Pediatr. 2022 Apr;181(4):1429-1436. doi: 10.1007/s00431-022-04373-3. Epub 2022 Jan 12.
PubMed 35020049World Health Organization. (2025). Kangaroo mother care: Clinical practice guide. https://www.who.int/publications/m/item/kangaroo-mother-care--a-clinical-practice-guide
Welikala, D., & Xavier, M. (2023). Student Nurses Experiences of Learning in Clinical Placement in NICU: a descriptive literature review. (Bachelor's Thesis, Metropolia University of Applied Sciences).
Uslu, Y. (2020). Simülasyona Dayalı Öğrenmenin Değerlendirilmesi Ölçeği: Türkçe Geçerlilik ve Güvenilirlik Çalışması•. Journal of Education & Research in Nursing/Hemşirelikte Eğitim ve Araştırma Dergisi, 17.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neonatal Intensive Care Unit Scenario-Based Simulation Training on Nursing Students' Perceived Stress, Learning Satisfaction, Self-Confidence, and Simulation-Based Learning: A Mixed-Methods Study
- ClinicalTrials.gov ID
- NCT07653308
- Acronym / sponsor ID
- E-59394181-100-137319
- Conditions
- Nursing Education, Simulation Based Learning, Stress, Psychological, Nursing Students, Neonatal Intensive Care
- Keywords
- neonatal intensive care simulation, nursing students, perceived stress, learning satisfaction, self-confidence, simulation-based learning, PEARLS debriefing, mixed methods
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Atılım UniversityUniversity, hospital or other
- Study start
- 18 May 2026 (actual)
- Primary completion
- 12 Jun 2026 (estimated)
- Study completion
- 12 Jun 2026 (estimated)
- First posted
- 17 Jun 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 mixed-methods study examines the effects of neonatal intensive care unit (NICU) scenario-based simulation training on third-year nursing students' perceived stress, learning satisfaction, self-confidence, and simulation-based learning experiences. All eligible participants will receive a high-fidelity simulation session involving a NICU scenario that includes therapeutic communication with a postpartum mother, neonatal emergency intervention, and support for mother-infant interaction. The simulation protocol consists of prebriefing (3 minutes), environmental orientation (3 minutes), scenario-based simulation (10 minutes), and debriefing using the PEARLS model (30 minutes). Quantitative data will be collected before and after the simulation using validated scales. Qualitative data will be gathered through semi-structured focus group interviews following the simulation. The study aims to provide evidence on the effectiveness of NICU simulation-based education in nursing training.
Detailed description
Neonatal intensive care units (NICUs) are complex clinical environments requiring advanced technical skills, rapid decision-making, teamwork, and effective communication. Nursing students often face significant challenges in these settings, including stress related to patient acuity, fear of making errors, and difficulties in communicating with emotionally vulnerable parents.
This study will be conducted at Atılım University Faculty of Health Sciences, Nursing Skills Laboratory in Ankara, Turkey. Third-year nursing students who have not yet completed the Child Health and Diseases (NURS302) course will be eligible to participate. The entire third-year cohort (n=18) will be invited to participate; no sampling will be applied.
The study employs a parallel mixed-methods design. The quantitative component uses a single-group pre-post quasi-experimental design. The qualitative component involves semi-structured focus group interviews to explore students' simulation experiences in depth.
The NICU simulation scenario includes three interconnected components: initiating therapeutic communication with a postpartum mother whose preterm infant is admitted to the NICU, performing emergency neonatal intervention during an acute event, and supporting the initiation of mother-infant contact and breastfeeding. The scenario was developed in accordance with the Healthcare Simulation Standards of Best Practice™.
Data collection will occur in three phases. In Phase 1, participants will complete the Student Descriptive Information Form and the Perceived Stress Scale for Nursing Students (pre-test). In Phase 2, the simulation and PEARLS-based debriefing will be conducted, followed by post-test administration of the Perceived Stress Scale, Simulation-Based Learning Evaluation Scale, and Student Satisfaction and Self-Confidence in Learning Scale. In Phase 3, semi-structured focus group interviews will be conducted and audio-recorded with participant consent.
Quantitative data will be analyzed using SPSS 29.0. Qualitative data will be analyzed using MAXQDA through thematic coding. Findings from both components will be integrated during the interpretation phase.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NICU Simulation Group | Experimental | Behavioral: NICU Scenario-Based Simulation TrainingThird-year nursing students who received a high-fidelity NICU scenario-based simulation training including prebriefing, simulation, and PEARLS-based debriefing phases, followed by semi-structured focus group interviews. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Third-year undergraduate nursing students at Atılım University Faculty of Health Sciences
- Voluntarily willing to participate and providing written informed consent
- Have not yet completed the Child Health and Diseases (NURS302) course
Key exclusion criteria (2 listed)
- Withdrawal from the study at any stage
- Incomplete completion of data collection forms
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 |
|---|---|---|
| NICU Scenario-Based Simulation TrainingA structured high-fidelity simulation protocol consisting of prebriefing (3 min), environmental orientation (3 min), NICU scenario-based simulation (10 min), and PEARLS model debriefing (30 min). The scenario includes therapeutic communication with a postpartum mother, neonatal emergency intervention, and support for mother-infant interaction and breastfeeding initiation. | Behavioural | NICU Simulation Group |
Primary outcome
Perceived Stress Scale for Nursing Students Score
Time frame: Baseline (before simulation) and immediately after debriefing
Pre- and post-simulation total scores on the Perceived Stress Scale for Nursing Students measuring students' perceived stress levels during clinical training
Simulation-Based Learning Evaluation Scale Score
Time frame: Immediately after debriefing
Post-simulation total score on the Simulation-Based Learning Evaluation Scale measuring nursing process, patient safety, professional knowledge, communication, and reflective behavior
2 secondary outcomes
Student Satisfaction and Self-Confidence in Learning Scale Score
Time frame: Immediately after debriefing
Simulation Experience - Qualitative Findings
Time frame: Immediately after debriefing
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 17 Jun 2026.
- Background: PubMed 41602019Shi Z, Li X, Hu Y, Yang R, Zeng Z, Hou S. Barriers and facilitators to the implementation of the kangaroo mother care in NICUs of high-income and low- and middle-income countries: a scoping review. Front Public Health. 2026 Jan 12;13:1701738. doi: 10.3389/fpubh.2025.1701738. eCollection 2025.
- Background: PubMed 35596536Salifu DA, Christmals CD, Reitsma GM. Frameworks for the design, implementation, and evaluation of simulation-based nursing education: A scoping review. Nurs Health Sci. 2022 Sep;24(3):545-563. doi: 10.1111/nhs.12955. Epub 2022 Jun 6.
- Background: PubMed 30893093Masten M, Sommerfeldt S, Gordan S, Greubel E, Canning C, Lioy J, Chuo J. Evaluating Teamwork in the Neonatal Intensive Care Unit: A Survey of Providers and Parents. Adv Neonatal Care. 2019 Aug;19(4):285-293. doi: 10.1097/ANC.0000000000000604.
- BackgroundKaraca, A., Yıldırım, N., Ankaralı, H., Açıkgöz, F. ve Akkuş, D. (2015). Hemşirelik Öğrencileri İçin Algılanan Stres, Biyo-Psiko-Sosyal Cevap ve Stresle Başetme Davranışları Ölçeklerinin Türkçe'ye uyarlanması. Psikiyatri Hemşireliği Dergisi, 6(1), 15-25.
- BackgroundEyikara, E., & Baykara, Z. G. (2017). The Importance of Simulation in Nursing Education. World Journal on Educational Technology: Current Issues, 9(1), 2-7.
- Background: PubMed 41384238Decataldo A, Lauritano G, Paleardi F. The fragile dialogue: communication barriers, authority and adaptive strategies in NICU parent-healthcare worker relationships. Front Sociol. 2025 Nov 26;10:1683833. doi: 10.3389/fsoc.2025.1683833. eCollection 2025.
- BackgroundCreswell, J. W., & Plano Clark, V. L. (2018). Designing and conducting mixed methods research (3rd ed.). Sage Publications.
- Background: PubMed 37214501Bry A, Wigert H, Bry K. Need and benefit of communication training for NICU nurses. PEC Innov. 2023 Feb 14;2:100137. doi: 10.1016/j.pecinn.2023.100137. eCollection 2023 Dec.
- BackgroundBilyk, A. (2024). The Lived Experience of Parents with Newborns in the Neonatal Intensive Care Unit (NICU): A Heuristic Inquiry (Doctoral dissertation, Walden University).
- BackgroundAndretta, V., Cerrone, V., Strini, V., & Prendin, A. (2025). Family-centered care in pediatric and neonatal intensive care units: A systematic review. Patient Experience Journal, 12(2), 76-82. https://pxjournal.org/journal/vol12/iss2/14/
- Background: PubMed 34654046Zebreski L, Bloodgood K, Wyble K. Preparing Neonatal Nurses for Improved Performance, Professional Development, and National Certification Through Simulation. Adv Neonatal Care. 2022 Aug 1;22(4):E131-E136. doi: 10.1097/ANC.0000000000000946. Epub 2021 Oct 12.
- Background: PubMed 35020049Yousef N, Moreau R, Soghier L. Simulation in neonatal care: towards a change in traditional training? Eur J Pediatr. 2022 Apr;181(4):1429-1436. doi: 10.1007/s00431-022-04373-3. Epub 2022 Jan 12.
- Atilim University web pageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study involves a small sample of nursing students from a single institution, which may increase the risk of participant identification despite de-identification procedures. In addition, the study includes qualitative interview data that may contain information that could potentially compromise participant confidentiality. Only aggregated and anonymized results will be reported in publications and presentations.
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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.
Didem Yüksel, PhD principal investigator
Atılım University, Faculty of Health Sciences, Department of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NICU Scenario-Based Simulation Training in people with Nursing Education and Simulation Based Learning, run by Atılım University 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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale for Nursing Students Score (time frame: Baseline (before simulation) and immediately after debriefing). The study lists 2 primary outcomes in all. 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 NCT07653308, which also lists 28 linked publications.
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 17 Jun 2026; AzTrials last refreshed its copy on 3 Nov 2026.