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Educational ProblemsNCT06993649

Evaluation of Ability to Have a Normal Birth and Simulation

A study testing Experimental High Reality Simulator, Experimental Medium Reality Simulator and Experimental Simulated Woman in people with Educational Problems, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Educational Problems
What is being tested?
Experimental High Reality Simulator, Experimental Medium Reality Simulator and Experimental Simulated Woman
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteTurkey (Türkiye)
Study dates
4 Nov 2024to 4 Feb 2025
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 Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Tokat Gaziosmanpaşa Üniversitesi

    Tokat Province, 60250

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of Ability to Have a Normal Birth Using Different Simulation Methods: A Randomized Controlled Trial

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.

Read the detailed description

The midwifery profession is a combination of knowledge and skills. In this process, it is very important for educators to understand students' learning processes, know how to transfer practical applications to the clinical environment, and use different educational techniques. The increase in the number of students in midwifery education in Türkiye, the reduction of student density in hospitals especially during the pandemic period, limited suitable clinical practice areas and the low number of educators, patient safety, ethical and legal sanctions, etc. make it necessary to integrate different teaching techniques into education. Depending on these processes, educators should follow innovative educational techniques and strengthen the skills of students before they go to the clinic. In order to achieve these desired goals in students, simulation education techniques have been frequently used recently.

In the literature, simulation is defined as "a method that reflects a clinical situation as close to reality as possible and makes it easier to understand and manage when encountered in clinical practice". It is emphasized that simulated patient education reinforces theoretical knowledge and practice by providing students with a realistic clinical experience before they go to the clinic, is effective in gaining critical thinking, decision-making and psychomotor skills, and increases individual learning. In midwifery practice education, simulation can often be used to transfer knowledge, teach simple/complex technical skills, communication, teamwork and clinical decision-making processes.

In addition, simulation training has benefits in midwifery practices such as; Increasing their self-confidence, Developing clinical decision-making skills, Gaining experience by learning from their mistakes without harming patients, Reducing their anxiety about the clinic, Increasing the quality of their work, Achieving the ability to apply complete care, technical skills, decision-making, evaluation, teamwork and management skills .

Simulation is mostly preferred in the teaching of practical interventions. The acquisition of the ability to perform normal births, which is the basis of these practices, is one of the most important outcomes of the midwifery program.

However, the difficulties encountered during clinical education cause midwifery students to graduate without performing a sufficient number of independent normal births.The most important reason for these difficulties is the inadequacy of the application areas to meet the increasing number of students and the inadequacy of the number of women performing normal births due to the increasing number of cesarean births. However, in our country, midwifery students must fulfill the requirement of performing 40 normal births in order to graduate according to the provisions of the "Regulation on the Determination of Minimum Education Conditions for Medical, Nursing, Midwifery, Dentistry, Veterinary, Pharmacy and Architecture Education Programs" numbered 26775 and dated 2 February 2008.

The primary people responsible for normal birth are midwives. Therefore, the quality of the training to be given during midwifery education regarding the application of normal birth is extremely important. Midwifery students need to be competent both practically and theoretically before encountering a real case during birth. At the same time, since normal birth practice is a very complex practice, it can cause serious stress in the student due to the risks it carries.The high stress level of the student can cause the student to not respond effectively to stress and to fail in the application. Again, at this point, it is thought that performing these applications on simulators many times in order to reduce the effects of stress on the application can improve the situation.

Providing training for vaginal birth and emergency obstetric cases with simulation method can contribute to the reduction of malpractices, increase in team cooperation and coordination, increase in clinical decision-making skills within the team, increase maternal satisfaction during birth and increase in vaginal birth rates. Many studies have found that training with simulation in healthcare professionals increases knowledge and skills on vaginal birth and obstetric emergencies, increases self-confidence and learning satisfaction, provides a safe learning environment and contributes to the development of correct decision-making skills.When the simulation studies on midwifery skill training are examined, it has been found that skill training with simulation improves the learning, skills, teamwork, communication, decision-making and critical thinking skills of students in pregnancy, birth and emergency situations.

The research was conducted in a quasi-experimental randomized controlled design. The research will be conducted in the skill laboratories of the Midwifery Department of the Faculty of Health Sciences at Tokat Gaziosmanpaşa University.

The study will be conducted in the Department of Midwifery, Faculty of Health Sciences, during the 2024-2025 academic year. The sample of the study will consist of all third-year students (102 people) who registered for the Normal Birth and Postpartum Period course in the midwifery department for the first time. It is reported in the literature that in experimental studies, a sample size of at least 30 people is required to conduct parametric tests. In this study, the number of students in the groups was determined as 34 considering that there may be losses.

Students will be divided into three groups as d1= High Reality simulator, d2= Medium Reality simulator group and d3= simulated women group.

A total of 102 students will be studied. Students who meet the criteria for inclusion in the study will be given a sequence number and then randomly divided into 3 groups using the online randomization program https://www.randomizer.org.

Data Collection Tools In collecting the data; Introductory Information Form, Academic Motivation Scale and Student Satisfaction in Learning and Self-Confidence Scale will be used.

Introductory Information Form; It was created by the researchers by scanning the literature .This form consists of a total of 8 questions including the socio-demographic characteristics of the students, the presence of a health worker in the family, normal birth application status and characteristics related to simulation training (age, high school graduation, monthly income status, the presence of a health worker in the family, the status of receiving simulation training, etc.).

Motivation and Learning Strategies Scale This scale consists of two sections: Motivation Scale and Learning Strategies Scale .The Motivation Scale section of Motivation and Learning Strategies Scale was used to determine the criterion validity of the developed scale.The Motivation Scale consist of the factors of intrinsic goal regulation (items 1, 16, 22 and 24), extrinsic goal regulation (items 7, 11, 13 and 30), task value (items 4, 10, 17, 23, 26 and 27), self-efficacy perception regarding learning and performance (items 5, 6, 12, 15, 20, 21, 29 and 31), control belief regarding learning (items 2, 9, 18 and 25) and test anxiety (items 3, 8, 14, 19 and 28) factors.Cronbach alpha coefficients of the factors ranged between 0.86 and 0.41, and corrected item-total score correlation coefficients ranged between 0.19 and 0.66. Individuals mark their level of agreement with each statement on the scale on a seven-point rating scale ranging from "Absolutely False for Me" "1" to "Absolutely True for Me" "7". There is no cut-off point or reverse-scored item in the score calculation of the scale. A high score from any factor of the scale indicates that the student has a high level of the characteristic related to the said factor .

Student Satisfaction and Self-Confidence in Learning Scale;The original scale was developed as 13 items, and the total number of items was reduced to 12 during the adaptation to Turkish. The scale is a 5-point Likert-type scale and consists of the subheadings "Satisfaction with Current Learning" and "Self-confidence in Learning".

The subheading of satisfaction with current learning consists of 5 items, the subheading of self-confidence in learning consists of 7 items, and there are no negative items. The Cronbach alpha value of the scale for "Satisfaction with Current Learning" is .85, for "Self-confidence in Learning" it is .77, and for the total scale it is .89. Scale scores are obtained by dividing the sum of the sub-dimensions by the number of items.As the total score obtained from the scale increases, student satisfaction and self-confidence in learning also increase.

Application of the Research

All students taking the Normal Birth and Postpartum Period Course will be provided with the necessary information regarding normal birth practice within the scope of the course curriculum by the responsible lecturer of the course conducting the research, using the traditional learning method within the scope of slide presentation and video presentation.

At the end of the theoretical course; TBF will be applied to all students. After the theoretical lecture, normal labour skills training will be done in laboratory practice.

All students will be shown the process steps including normal labour skills on the simulator respectively by the instructor explaining the theoretical part of normal labour.

Then, 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.

Each group will work in different laboratories. Students will be taken to the laboratory practice by the same researcher in turns, without seeing each other.After the laboratory applications are completed, all students will be administered Motivation and Learning Strategies Scale and Student Satisfaction and Self-Confidence in Learning Scale . After the theoretical and laboratory parts of the course are completed, students will go to clinical practice for 8 weeks. After the clinical application, all students will be administered Motivation and Learning Strategies Scale and Student Satisfaction and Self-Confidence in Learning Scale again.

Statistical Analysis In the evaluation of the research data, Chi-Square Test (Chi Square Test) "paired sample t test in dependent groups", "independent sample t test" and Anova test will be used for intergroup evaluations.Statistical comparisons will be made with Mann-Whitney U-test and Wilcoxon Test. Variance Analysis or Friedman Variance Analysis will be used in Repeated Measures.The significance level will be accepted as p<0.05."

Being tested
Experimental High Reality Simulator, Experimental Medium Reality Simulator, Experimental Simulated Woman
Keywords
normal birth skills, midwifery, simulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental High Reality SimulatorBehavioural

    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 Medium Reality SimulatorBehavioural

    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 Simulated WomanBehavioural

    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.

Study groups in NCT06993649
Study groupRoleWhat they receive
Experimental High Reality simulatorExperimentalThe 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.
Receives: Behavioral: Experimental High Reality Simulator
Experimental Medium Reality SimulatorExperimentalThe 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.
Receives: Behavioral: Experimental Medium Reality Simulator
Experimental Simulated WomanExperimentalThe 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.
Receives: Behavioral: Experimental Simulated Woman

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Motivation Scale

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

    Measured: one hour- two months

  2. Student Satisfaction and Self-Confidence in Learning Scale

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

    Measured: one hour- two months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2025
  2. Study start4 Nov 2024
  3. Primary completion4 Jan 2025
  4. Study completion4 Feb 2025

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06993649
Sponsor's protocol ID
TOKAT04
Status last verified
May 2025
First submitted
4 Apr 2025
Last updated
29 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lathrop A, Winningham B, VandeVusse L. Simulation-based learning for midwives: background and pilot implementation. J Midwifery Womens Health. 2007 Sep-Oct;52(5):492-8. doi: 10.1016/j.jmwh.2007.03.018.

    PubMed 17826713
  • 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.

  • 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

  • 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

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

  • 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.

  • 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.

    PubMed 17457121
  • 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.

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

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

  • 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

  • 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.

    PubMed 25772212
  • 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.

    PubMed 17138783
  • 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.

    PubMed 19680082
  • 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.

    PubMed 30938581

Questions about this trial

What is this clinical trial studying?

A study testing Experimental High Reality Simulator, Experimental Medium Reality Simulator and Experimental Simulated Woman in people with Educational Problems, run by Tokat Gaziosmanpasa 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 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: finished, as of the sponsor's last update on 29 May 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Motivation Scale (time frame: one hour- two months). 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 NCT06993649, which also lists 29 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 29 May 2025.

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