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

December 4, 2020 updated by: Aysegul Durmaz

The Effects of Mıxed Sımulatıon Traınıng Used in Vagınal Chıldbırth Wıth Epısıotomy on Student Medıcal 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kutahya, Turkey, 43000
        • Kütahya Health Science University
      • Kutahya, Turkey
        • Kütahya Health Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Experimental group received the course explaining vaginal delivery for the first timethat used simulation-based training.
Behavioral: Simulation-based training
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.
No Intervention: Control Group
Control group received the course explaining vaginal delivery for the first time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 week after the intervention
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.
2 week after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aysegul Durmaz

Investigators

  • Principal Investigator: Aysegul Durmaz, KSBU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2016

Primary Completion (Actual)

January 7, 2017

Study Completion (Actual)

September 18, 2017

Study Registration Dates

First Submitted

November 28, 2020

First Submitted That Met QC Criteria

December 4, 2020

First Posted (Actual)

December 7, 2020

Study Record Updates

Last Update Posted (Actual)

December 7, 2020

Last Update Submitted That Met QC Criteria

December 4, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Sim. Malp. Percep.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Access Criteria

If study IPD is used, my article should be cited.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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