NCT06993649

Brief Summary

The research is planned to be conducted in a randomized controlled design in order to determine the "Evaluation of Normal Birth Skills with Different Simulation Methods" of midwifery students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 4, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

April 4, 2025

Last Update Submit

May 25, 2025

Conditions

Keywords

normal birth skillsmidwiferysimulation

Outcome Measures

Primary Outcomes (2)

  • Motivation Scale

    "1" not at all true for me, "7" very true for me

    one hour- two months

  • Student Satisfaction and Self-Confidence in Learning Scale

    1. "strongly disagree" 2. "disagree" 3. "undecided" 4. "agree" 5. "strongly agree"

    one hour- two months

Study Arms (3)

Experimental High Reality simulator

EXPERIMENTAL

The steps of the process including normal labor skills will be done by each student in the d1= High Reality simulator (full-size, computer-based, time-adjusted, mother's statements about pain, performed with a female robotic simulator, Noelle S575 Mother and Newborn simulator)will be done to each student in the group respectively.

Behavioral: Experimental High Reality Simulator

Experimental Medium Reality Simulator

EXPERIMENTAL

The steps of the process including normal labor skills will be done by each student in the d2= Medium Reality simulator (full-size, fetal heart sounds can be listened to, time-adjusted with a simple hand monitor, birth process performed with an automatic birth system, SB32878U full-size birth model) will be done to each student in the group respectively.

Behavioral: Experimental Medium Reality Simulator

Experimental Simulated Woman

EXPERIMENTAL

The process steps including normal labour skills will be shown on d3= simulated woman (manual delivery of the baby, Gaumard S500 Half-Length Birth Simulator on which the midwifery student will apply the labour scenario) will be done to each student in the group respectively.

Behavioral: Experimental Simulated Woman

Interventions

The process steps including normal labour skills will be shown on d1= High Reality simulator (full-size, computer-based, time-setting, expressions of pain from the mother, performed with a female robotic simulator, Noelle S575 Mother and Newborn simulator), d2= Medium Reality simulator (full-size, fetal heart sounds can be listened, SB32878U full-length birth model, timed with a simple hand-held monitor, birth process is performed with an automatic birth system) and d3= simulated woman (manual delivery of the baby, Gaumard S500 Half-Length Birth Simulator on which the midwifery student will apply the labour scenario) will be done to each student in the group respectively.

Experimental High Reality simulator

The process steps including normal labour skills will be shown on d2= Medium Reality simulator (full-size, fetal heart sounds can be listened, SB32878U full-length birth model, timed with a simple hand-held monitor, birth process is performed with an automatic birth system) will be done to each student in the group respectively.

Experimental Medium Reality Simulator

Then, the process steps including normal labour skills will be shown d3= simulated woman (manual delivery of the baby, Gaumard S500 Half-Length Birth Simulator on which the midwifery student will apply the scenario of labour by the midwifery student) will be done to each student in the group respectively.

Experimental Simulated Woman

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • To be enrolled in Normal Birth and Postnatal Period Course for the first time
  • Not having participated in labour before
  • To volunteer to participate in the study

You may not qualify if:

  • \. To be enrolled in the Normal Birth and Postnatal Period Course for the second time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpaşa Üniversitesi

Tokat Province, 60250, Turkey (Türkiye)

Location

Related Publications (29)

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    PMID: 17826713BACKGROUND
  • Uyar Hazar, H., & Gültekin, S. (2019). Ebelik Eğitiminde Simülasyon Kullanımı, Life Sciences (NWSALS), 14(3), 74-83. DOI: 10.12739/NWSA.2019.14.3.4B0027.

    BACKGROUND
  • Edeer, A. D., & Sarikaya, A. (2015). The use of simulation in nursing education and simulation types/Hemsirelik egitiminde simulasyon kullanimi ve simulasyon tipleri. Journal of Education and Research in Nursing, 12(2), 121-126

    BACKGROUND
  • Nehring, W.M., & Lashley, F.R. (2009). Nursing simulation: A review of the past 40 years. Simulation & Gaming, 40(4), 528-552. https://doi.org/10.1177/1046878109332282

    BACKGROUND
  • Şendir, M. (2013). Use of simulation in women's health nursing education. F.N. Hem. Derg. 2013; 21(3): 205-212.

    BACKGROUND
  • Durmaz, A., Elem, E., Unutkan, A., & Keskin, N. (2017). The effect of simulation on vaginal delivery skills and self-sufficiency levels. J Curr Res Health Secto, 7(2), 41-52.

    BACKGROUND
  • Morgan PJ, Pittini R, Regehr G, Marrs C, Haley MF. Evaluating teamwork in a simulated obstetric environment. Anesthesiology. 2007 May;106(5):907-15. doi: 10.1097/01.anes.0000265149.94190.04.

    PMID: 17457121BACKGROUND
  • Gardner R, Raemer DB. Simulation in obstetrics and gynecology. Obstet Gynecol Clin North Am. 2008 Mar;35(1):97-127, ix. doi: 10.1016/j.ogc.2007.12.008.

    PMID: 18319131BACKGROUND
  • Göriş S., Bilgi N., Korkut Bayındır S. Hemşirelik Eğitiminde Simülasyon Kullanımı. Düzce Üniversitesi Sağlık Bilimleri Enstitüsü Dergisi 2014; 4 (2): 25-29

    BACKGROUND
  • Kamu Mevzuat Sistemi. https://kms.kaysis.gov.tr/Home/Goster/104346 erişim tarihi: 06.02.2018

    BACKGROUND
  • Demirel, G., Evcili, F., Kaya, N., Doganer, A. (2020). The effect of episiotomy repair simulation on the anxiety and self-efficacy levels of midwifery students. Journal of Midwifery and Reproductive Health, 8(1), 2050-2057. DOI: 10.22038/jmrh.2019.42024.1479

    BACKGROUND
  • DeStephano CC, Chou B, Patel S, Slattery R, Hueppchen N. A randomized controlled trial of birth simulation for medical students. Am J Obstet Gynecol. 2015 Jul;213(1):91.e1-91.e7. doi: 10.1016/j.ajog.2015.03.024. Epub 2015 Mar 12.

    PMID: 25772212BACKGROUND
  • Crofts JF, Bartlett C, Ellis D, Hunt LP, Fox R, Draycott TJ. Training for shoulder dystocia: a trial of simulation using low-fidelity and high-fidelity mannequins. Obstet Gynecol. 2006 Dec;108(6):1477-85. doi: 10.1097/01.AOG.0000246801.45977.c8.

    PMID: 17138783BACKGROUND
  • Dayal AK, Fisher N, Magrane D, Goffman D, Bernstein PS, Katz NT. Simulation training improves medical students' learning experiences when performing real vaginal deliveries. Simul Healthc. 2009 Fall;4(3):155-9. doi: 10.1097/SIH.0b013e3181b3e4ab.

    PMID: 19680082BACKGROUND
  • Mert Karadas M, Terzioglu F. The impact of the using high-fidelity simulation and standardized patients to management of postpartum hemorrhage in undergraduate nursing students: A randomized controlled study in Turkey. Health Care Women Int. 2019 May;40(5):597-612. doi: 10.1080/07399332.2019.1583229. Epub 2019 Apr 2.

    PMID: 30938581BACKGROUND
  • Lewis R, Strachan A, Smith MM. Is high fidelity simulation the most effective method for the development of non-technical skills in nursing? A review of the current evidence. Open Nurs J. 2012;6:82-9. doi: 10.2174/1874434601206010082. Epub 2012 Jul 27.

    PMID: 22893783BACKGROUND
  • Hughes, C., Anderson, G., Patterson, D., & O'Prey, M. (2014). Introducing an obstetric emergency training strategy into a simulated environment. British Journal of Midwifery, 22(3), 201-207

    BACKGROUND
  • Arias T, Tran A, Breaud J, Fournier JP, Bongain A, Delotte J. A prospective study into the benefits of simulation training in teaching obstetric vaginal examination. Int J Gynaecol Obstet. 2016 Jun;133(3):380-4. doi: 10.1016/j.ijgo.2015.08.028. Epub 2016 Feb 23.

    PMID: 26971257BACKGROUND
  • Yılar Erkek, Z., & Öztürk Altınayak, S. (2024, September). Assessing the Efficacy of Medium- and High-Reality Simulators in Normal Labor Management: A Randomized Controlled Trial. Clinical Simulation in Nursing, 94, 101599. https://doi.org/10.1016/j.ecns.2024.101599

    BACKGROUND
  • Yılar Erkek, Z., & Öztürk Altınayak, S. (2021, Month). The Effect of Simulation Teaching Technique on the Improvement of Episiotomy Performance Skills and State Anxiety of Midwifery Students in Turkey: RCT. Clinical Simulation in Nursing , 54, 62-69. https://doi.org/10.1016/j.ecns.2021.01.014 .

    BACKGROUND
  • Erkek, Z. Y., Alparslan, Ö., & Altınayak, S. Ö. (2021). The effect of simulation-based training about emergencies and approaches to delivery given to emergency personel. Clinical and Experimental Health Sciences, 11(1), 96-104.

    BACKGROUND
  • Carolan-Olah M, Kruger G, Brown V, Lawton F, Mazzarino M, Vasilevski V. Communicating out loud: Midwifery students' experiences of a simulation exercise for neonatal resuscitation. Nurse Educ Pract. 2018 Mar;29:8-14. doi: 10.1016/j.nepr.2017.10.027. Epub 2017 Oct 23.

    PMID: 29144999BACKGROUND
  • Maskalova E, Urbanova E, Baskova M, Kvaltinyova E. Experience of lecturers with simulation training in midwifery education in Slovakia. Midwifery. 2018 Apr;59:1-3. doi: 10.1016/j.midw.2018.01.001. Epub 2018 Jan 5.

    PMID: 29331775BACKGROUND
  • Özdamar, K. (2003). SPSS Statistical Package for the Social Sciences ile Bioistatistik. Eskişehir, Kaan Publisher.

    BACKGROUND
  • Khadivzadeh T, Erfanian F. The effects of simulated patients and simulated gynecologic models on student anxiety in providing IUD services. Simul Healthc. 2012 Oct;7(5):282-7. doi: 10.1097/SIH.0b013e31826064b7.

    PMID: 22864014BACKGROUND
  • Khalaila R. Simulation in nursing education: an evaluation of students' outcomes at their first clinical practice combined with simulations. Nurse Educ Today. 2014 Feb;34(2):252-8. doi: 10.1016/j.nedt.2013.08.015. Epub 2013 Sep 3.

    PMID: 24060462BACKGROUND
  • Unver V, Basak T, Watts P, Gaioso V, Moss J, Tastan S, Iyigun E, Tosun N. The reliability and validity of three questionnaires: The Student Satisfaction and Self-Confidence in Learning Scale, Simulation Design Scale, and Educational Practices Questionnaire. Contemp Nurse. 2017 Feb;53(1):60-74. doi: 10.1080/10376178.2017.1282319. Epub 2017 Feb 10.

    PMID: 28084900BACKGROUND
  • Büyüköztürk, Ş., Akgün, Ö. E., Kahveci, Ö., & Demirel, F. (2004). Güdülenme ve öğrenme stratejileri ölçeğinin Türkçe formunun geçerlik ve güvenirlik çalışması. Kuram ve Uygulamada Eğitim Bilimleri, 4(2), 207-239.

    BACKGROUND
  • Shaw-Battista J, Belew C, Anderson D, van Schaik S. Successes and Challenges of Interprofessional Physiologic Birth and Obstetric Emergency Simulations in a Nurse-Midwifery Education Program. J Midwifery Womens Health. 2015 Nov-Dec;60(6):735-43. doi: 10.1111/jmwh.12393. Epub 2015 Dec 1.

    PMID: 26624963BACKGROUND

Study Officials

  • Zümrüt YILAR ERKEK, Assoc. Prof.

    Tokat Gaziosmanpaşa University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 4, 2025

First Posted

May 29, 2025

Study Start

November 4, 2024

Primary Completion

January 4, 2025

Study Completion

February 4, 2025

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations