Clinical trial NCT06993649: Evaluation of Ability to Have a Normal Birth and Simulation
Official title: Evaluation of Ability to Have a Normal Birth Using Different Simulation Methods: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Problems
Keywords: normal birth skills
midwifery
simulation
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2025-05-29
Enrollment: 102
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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."

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Motivation Scale
timeFrame: one hour- two months
measure: Student Satisfaction and Self-Confidence in Learning Scale
timeFrame: one hour- two months
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpaşa Üniversitesi
Study officials:
affiliation: Tokat Gaziosmanpaşa University
name: Zümrüt YILAR ERKEK, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
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