Clinical trial NCT04656574: The Effects of Sımulatıon Used in Vagınal Chıldbırth on Malpractıce Tendency And Perceptıons of Care Behavıors
Official title: The Effects of Mıxed Sımulatıon Traınıng Used in Vagınal Chıldbırth Wıth Epısıotomy on Student Medıcal Malpractıce Tendency And Perceptıons of Care Behavıors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior
Perceptions
Keywords: Episiotomy
Medical Malpractice
Perceptions
Simulation
Vaginal Childbirth
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was conducted as a single blind, prospective, and simple randomized controlled trial. A power calculation was performed and with a standard deviation of 0.25 and statistical significance of 0.05, the number of students needed to total participate was determined to be 116, 58 per group. Out of 79 students, 60 were randomly assigned to the experimental group receiving education using simulation-based training and out of 90 students, 60 were randomly assigned to the control group that received the course explaining vaginal delivery for the first time.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: H1a: The simulation-based training used to provide delivery skills have an effect on malpractice trends of midwifery students.

H1b: The simulation-based training used to provide delivery skills have an effect on midwifery students' perceptions of care behaviors.

H0a: The simulation-based training used to provide delivery skills have not an effect on malpractice trends of midwifery students.

H0b: The simulation-based training used to provide delivery skills have not an effect on midwifery students' perceptions of care behaviors.

Detailed description: The study was conducted as a single blind, prospective, and simple randomized controlled trial. The study was conducted in the fall semester of 2016 and in the fall semester of 2017 in the midwifery department of a university.

The study universe comprised 79 students who took the course about vaginal delivery (which is included in the midwifery curriculum) provided using simulation-based training and 90 students taking this course for the first time. The study included 120 participants, including 60 randomly selected students who agreed to participate in the study, were enrolled in midwifery, and took the course explaining vaginal delivery for the first time and 60 randomly selected students who received this education using simulation-based training.

The simulation training included the activities that midwives should do during the birth and management of vaginal delivery. Bone pelvis, fetal head, fetus, cervical dilatation-effacement, fetal descensus, maternal-neonatal birthing simulators and chicken breast model for episiotomy were used by the researchers to monitor, manage, and provide care for the progress of labor. The students in the control group received theoretical training about management and care of vaginal delivery. In addition, the researchers demonstrated them how to monitor and manage the delivery process and provide care.

Data collection tools included a personal information form, medical malpractice tendency scale in nursing, and caring assessment questionnaire.

Statistical analyses were made using Statistical Package for Social Sciences (IBM SPSS) Statistics 22 software. The findings were analyzed using descriptive statistics (average, standard deviation, frequency, and percentage). The Kolmogorov-Smirnov test was used to determine normal distribution of the data.

Eligibility criteria: Inclusion Criteria:

* To receive simulation based training
* Older than 18 years,
* To Voluntary to participate,
* To know how to read, write and speak in Turkish,
* To do model work
* Fully completed the data collection forms
* To continue the all course

Exclusion Criteria:

* To received theoretical training,
* Younger than 18 years,
* Refuse to participate
* Not knowing how to read, write and speak Turkish,
* Not to do model work
* Not to fill the questionnaire
* Not to continue the course

Primary outcomes:
measure: medical malpractice tendency
timeFrame: 2 week after the intervention
measure: Perceptions of care behaviors
timeFrame: 2 week after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Science University
city: Kutahya
country: Turkey
facility: Kutahya Health Science University
Study officials:
affiliation: KSBU
name: Aysegul Durmaz
role: PRINCIPAL_INVESTIGATOR
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