Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
90 participants
INTERVENTIONAL
2022-10-10
2023-12-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The research was designed in a quasi-experimental randomized controlled type. The research is carried out in the Department of Midwifery, Faculty of Health Sciences, in the 2022-2023 academic year. The sample of the study consists of all third-year students who enrolled in the Normal Birth and Postpartum Term course in the midwifery department for the first time (102 students who successfully passed the Prenatal I course in the 2021-2022 academic year. These students are in the next 2022-2023 academic year. Registered for the Post Term Course). In the literature; In experimental studies, it has been reported that a sample size of at least 30 people is required in order to perform parametric tests (24). In this study, the number of students in the groups was determined as 32, considering that they may have lost. Students were divided into three groups as experimental (d1= High Reality simulator), (d2= Medium Reality simulator) group and control group (d3= slide and video presentation). The study is carried out with 96 students in total. The students who met the inclusion criteria were given a sequence number and then randomly divided into 3 groups using the https://www.randomizer.org online randomization program.
Data collection tools: In data collection; Introductory Information Form (IIF), Normal Birth Skills Assessment Form (NBSAF), Student Satisfaction and Self-Confidence Scale in Learning (SSSCSL) and Evaluation of Simulation-Based Learning Scale (ESSBL) will be used.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Normal Birth Skill Assessment Form (NBSAF) It was created by the researchers by scanning the literature (29-31). In the form, there are 50 items about the steps that the student should do during the normal labor practice. Evaluation of the form is as "he did" and "did not" in relation to the student's implementation of the activities to be observed during the normal labor process steps. In the form, the student was given 2 points for each activity he did, while 0 points were given for the activities he did not do. The lowest score that can be obtained from the form is 0, and the highest score is 100. A high score will indicate high skill, and a low score will indicate low skill.
For the content validity of the NBSAF items, the opinions of 5 experts (2,3,32-34) who have researched on learning techniques related to the management of normal labor were consulted. The Lawshe technique was used to evaluate the content validity of the items in the form. According to the Lawshe technique, the minimum fit criterion was 0.99 for five experts (35). No item with a content validity ratio below 0.99 was detected. In order to test the intelligibility of the items, a pilot study was conducted with 10 students from another class who had no knowledge of the content, and the form was given its final form.
Student Satisfaction and Self-Confidence Scale in Learning (SSSCSL) The original scale was developed as 13 items by Jeffries and Rizzolo (2006), and the total number of items decreased to 12 during its adaptation to Turkish. The adaptation of the scale to Turkish was done by Ünver et al. (2017). The scale is a 5-point Likert type and consists of the sub-headings of "Satisfaction with Current Learning" and "Self-Confidence in Learning". The sub-title of satisfaction with current learning consists of 5 items, the sub-title of self-confidence in learning consists of 7 items and there is no negative item. The cronbach alpha value of the scale for "Satisfaction with Current Learning" is .85, while it is .77 for "Self-Confidence in Learning", it is .89 for the total scale. Scale scores; It is 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.
Evaluation Scale of Simulation-Based Learning (ESSBL) The original scale was developed by Hung et al. (2016), and its Turkish validity and reliability were performed by Uslu and Yavuz van Giersbergen (2020). The Turkish validity and reliability of the scale consists of 5 sub-dimensions and 37 items. Responses are scored on a five-point Likert system, ranging from 1 (strongly disagree) to 5 (strongly agree), and the total score varies between 37-185. All statements in the scale are positive and there is no reverse coded item. Within the scope of the scale, the basic competencies that midwives and nurses should have; care process, patient safety, professional knowledge, communication and reflected behavior concepts are evaluated. An increase in the score obtained from the sub-dimensions in the scale means that the sub-dimension goal has been achieved for the student in the scenario (37).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
d1
NBSAF's first rating on a full-reality birth simulator. During the first normal delivery practice of the student in the hospital environment, the second evaluation of NBSAF and the second application of SSSCSL and ESSBL were made.
practice on birth simulator
making attempts at labor
d2
An initial evaluation of NBSAF was performed on a medium reality labor stimulator. During the first normal delivery practice of the student in the hospital environment, the second evaluation of NBSAF and the second application of SSSCSL and ESSBL were made.
practice on birth simulator
making attempts at labor
d3 (control)
Without any simulation application, the second evaluation of NBSAF and the second application of SSSCSL and ESSBL were performed during the first normal delivery practice of the student in the hospital environment.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
practice on birth simulator
making attempts at labor
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
28 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tokat Gaziosmanpasa University
OTHER
Ondokuz Mayıs University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Serap Ozturk Altinayak
assistant professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Health Research and Training Hospital of Tokat Gaziosmanpaşa University
Tokat Province, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22-KAEK-166
Identifier Type: -
Identifier Source: org_study_id