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Completed

NCT Number: NCT04656574

The Effects of Sımulatıon Used in Vagınal Chıldbırth on Malpractıce Tendency And Perceptıons of Care Behavıors

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kutahya Health Science University, Kütahya, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

simulation-based training

Behavioral

The simulation training included the activities that midwives should do during the birth and management of vaginal delivery with episiotomy. The students received theoretical training, and to reinforce it, they were asked to mold a fetal head from a potato, make a cardboard cervix showing dilatation measurements during vaginal delivery, and make a fetal position identification model taking the occiput as a reference point.

Primary outcomes

  1. medical malpractice tendency

    Time frame: 2 week after the intervention

    The medical malpractice tendency scale in nursing includes routine patient care activities of the nurses. It was developed by Özata and Altunkan (14). The Likert-type scale, scored between 1 and 5, includes 49 items and consists of five subscales. The scoring is 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always. The minimum score is 49 and maximum is 245 points. A higher total score indicates that nurses have less medical malpractice tendencies. The scale includes five subscales: drug and transfusion administration, prevention of infections, patient monitıring and material-device safety, prevention of falls, and communication.

  2. Perceptions of care behaviors

    Time frame: 2 week after the intervention

    Caring Assessment Questionnaire/Care-Q scale: The caring assessment questionnaire/Care-Q was developed by Lee, Larson, and Holzemer (18) and adapted to Turkish by Eskimez and Acaroğlu (19). This Likert-type scale, scored between 1 and 7, includes 50 items and consists of six subscales. The scoring is 1=Never, 2=Rarely, 3=Occasionally, 4=Sometimes, 5=Frequently, 6=Usually, 7=Every time. The minimum score is 50 and maximum is 350 points. A higher score indicates a positive increase in the frequency of providing and perceiving care behaviors. The six subscales are attainability, descriptions and facilities, comfort, expectations, reassuring communication, and observation and follow-up.

Sponsors and collaborators

Lead sponsor

Aysegul Durmaz

Other

Registry information

Official study title

The Effects of Mıxed Sımulatıon Traınıng Used in Vagınal Chıldbırth Wıth Epısıotomy on Student Medıcal Malpractıce Tendency And Perceptıons of Care Behavıors

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 7, 2020
Registry last updated
Dec 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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