NCT07653308

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2026

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

25 days

First QC Date

June 12, 2026

Last Update Submit

June 12, 2026

Conditions

Keywords

neonatal intensive care simulationnursing studentsperceived stresslearning satisfactionself-confidencesimulation-based learningPEARLS debriefingmixed methodsNICU nursing educationfocus group

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    Immediately after debriefing

Secondary Outcomes (2)

  • Student Satisfaction and Self-Confidence in Learning Scale Score

    Immediately after debriefing

  • Simulation Experience - Qualitative Findings

    Immediately after debriefing

Study Arms (1)

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.

Behavioral: NICU Scenario-Based Simulation Training

Interventions

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.

NICU Simulation Group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Withdrawal from the study at any stage
  • Incomplete completion of data collection forms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atılım University Faculty of Health Sciences, Department of Nursing Simulation Laboratory

Ankara, 06830, Turkey (Türkiye)

Location

Related Publications (28)

  • 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.

    PMID: 41602019BACKGROUND
  • Salifu 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.

    PMID: 35596536BACKGROUND
  • Masten 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.

    PMID: 30893093BACKGROUND
  • Karaca, 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.

    BACKGROUND
  • Eyikara, E., & Baykara, Z. G. (2017). The Importance of Simulation in Nursing Education. World Journal on Educational Technology: Current Issues, 9(1), 2-7.

    BACKGROUND
  • 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.

    PMID: 41384238BACKGROUND
  • Creswell, J. W., & Plano Clark, V. L. (2018). Designing and conducting mixed methods research (3rd ed.). Sage Publications.

    BACKGROUND
  • 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.

    PMID: 37214501BACKGROUND
  • Bilyk, A. (2024). The Lived Experience of Parents with Newborns in the Neonatal Intensive Care Unit (NICU): A Heuristic Inquiry (Doctoral dissertation, Walden University).

    BACKGROUND
  • 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/

    BACKGROUND
  • 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.

    PMID: 34654046BACKGROUND
  • Yousef 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.

    PMID: 35020049BACKGROUND
  • World Health Organization. (2025). Kangaroo mother care: Clinical practice guide. https://www.who.int/publications/m/item/kangaroo-mother-care--a-clinical-practice-guide

    BACKGROUND
  • 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).

    BACKGROUND
  • 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.

    BACKGROUND
  • Tajik F, Mahmoodi M, Azodi P, Jahanpour F. Nurse-mother communication and support: Perceptions of mothers in neonatal units. Heliyon. 2024 Apr 6;10(8):e29325. doi: 10.1016/j.heliyon.2024.e29325. eCollection 2024 Apr 30.

    PMID: 38644893BACKGROUND
  • Siva, N., Nayak, B. S., Lewis, L. E. S., Velayudhan, B., & Noronha, J. A. (2025). Intervention strategies to enhance early mother-infant interaction at NICU-A systematic review. Journal of Neonatal Nursing, 31(3), 101671.

    BACKGROUND
  • Rodrigues SM, Shin SS, Pinto MD, Bounds DT, Terry J, Burton CW. Parenting Expectations, NICU Experiences, and Maternal Psychological Outcomes: An Exploratory Mixed-Methods Study. Adv Neonatal Care. 2024 Apr 1;24(2):195-207. doi: 10.1097/ANC.0000000000001139. Epub 2024 Jan 12.

    PMID: 38215024BACKGROUND
  • Phuwayanon S, Healy M, Boyle B. Diverse Parental Experiences of Kangaroo Care in Neonatal Units Across Healthcare Systems: A Meta-Synthesis. J Adv Nurs. 2026 Mar;82(3):1901-1927. doi: 10.1111/jan.17058. Epub 2025 May 19.

    PMID: 40387354BACKGROUND
  • Osborne AD, Worsley D, Cullen C, Martin A, Christ L. Enhancing NICU Care and Communication: Perspectives of Moderately Preterm Infant Parents. Pediatrics. 2024 Jun 1;153(6):e2023064419. doi: 10.1542/peds.2023-064419.

    PMID: 38716568BACKGROUND
  • Neugebauer C, Oh W, McCarty M, Mastergeorge AM. Mother-Infant Dyadic Synchrony in the NICU Context. Adv Neonatal Care. 2022 Apr 1;22(2):170-179. doi: 10.1097/ANC.0000000000000855. Epub 2021 Mar 30.

    PMID: 35703926BACKGROUND
  • Karacay, P. Kaya, H. (2017). Simülasyonla eğitimde kullanılan "Öğrenci Memnuniyeti ve Öğrenmede Kendine Güven Ölçeği"nin Türkçeye uyarlanması. Florence Nightingale Hemşirelik Dergisi, 25(2), 95-103.

    BACKGROUND
  • Guttmann KF, Raviv GN, Fortney CA, Ramirez M, Smith CB. Parent Perspectives on Communication Quality in the Neonatal Intensive Care Unit. Adv Neonatal Care. 2024 Aug 1;24(4):382-388. doi: 10.1097/ANC.0000000000001178. Epub 2024 Jul 8.

    PMID: 38975667BACKGROUND
  • Gong Z, He J, Zhang L. The effects of short- and long-duration Kangaroo Mother Care and conventional care on improving weight gain in low birth weight infants: a systematic review and meta-analysis. BMC Pediatr. 2025 Nov 10;25(1):918. doi: 10.1186/s12887-025-06267-3.

    PMID: 41214601BACKGROUND
  • Garg D, Chaudhury S, Saldanha D, Kumar S. Stress, postpartum depression, and anxiety in mothers of neonates admitted in the NICU: A cross-sectional hospital-based study. Ind Psychiatry J. 2023 Jan-Jun;32(1):48-58. doi: 10.4103/ipj.ipj_93_22. Epub 2022 Dec 9.

    PMID: 37274566BACKGROUND
  • Bonnot Fazio S, Dany L, Dahan S, Tosello B. Communication, information, and the parent-caregiver relationship in neonatal intensive care units: A review of the literature. Arch Pediatr. 2022 Jul;29(5):331-339. doi: 10.1016/j.arcped.2022.05.013. Epub 2022 May 27.

    PMID: 35644715BACKGROUND
  • Hwa GG, Avoli M. Cesium potentiates epileptiform activities induced by bicuculline methiodide in rat neocortex maintained in vitro. Epilepsia. 1991 Nov-Dec;32(6):747-54. doi: 10.1111/j.1528-1157.1991.tb05529.x.

    PMID: 1683833BACKGROUND
  • Chae S, Shon S. Effectiveness of simulation-based interprofessional education on teamwork and communication skills in neonatal resuscitation. BMC Med Educ. 2024 May 31;24(1):602. doi: 10.1186/s12909-024-05581-1.

    PMID: 38822320BACKGROUND

Related Links

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Didem Yüksel, PhD

    Atılım University, Faculty of Health Sciences, Department of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2026

First Posted

June 17, 2026

Study Start

May 18, 2026

Primary Completion

June 12, 2026

Study Completion

June 12, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations