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

NCT ID: NCT04656574

Last Updated: 2020-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-26

Study Completion Date

2017-09-18

Brief Summary

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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

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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.

Conditions

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Behavior Perceptions

Keywords

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Episiotomy Medical Malpractice Perceptions Simulation Vaginal Childbirth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants
Participants didn't know which group they were allocated. The participants will be blind when they receive simulation based training from researcher.

Study Groups

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Experimental Group

Experimental group received the course explaining vaginal delivery for the first timethat used simulation-based training.

Group Type EXPERIMENTAL

Simulation-based training

Intervention Type 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.

Control Group

Control group received the course explaining vaginal delivery for the first time

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aysegul Durmaz

OTHER

Sponsor Role lead

Responsible Party

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Aysegul Durmaz

Asst. Prof.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Aysegul Durmaz

Role: PRINCIPAL_INVESTIGATOR

KSBU

Locations

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Kutahya Health Science University

Kütahya, , Turkey (Türkiye)

Site Status

Kutahya Health Science University

Kütahya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Dearnley CA, Meddings FS. Student self-assessment and its impact on learning - a pilot study. Nurse Educ Today. 2007 May;27(4):333-40. doi: 10.1016/j.nedt.2006.05.014. Epub 2006 Jul 25.

Reference Type RESULT
PMID: 16870309 (View on PubMed)

Valen K, Holm AL, Jensen KT, Grov EK. Nursing students' perception on transferring experiences in palliative care simulation to practice. Nurse Educ Today. 2019 Jun;77:53-58. doi: 10.1016/j.nedt.2019.03.007. Epub 2019 Mar 30.

Reference Type RESULT
PMID: 30954856 (View on PubMed)

Lendahls L, Oscarsson MG. Midwifery students' experiences of simulation- and skills training. Nurse Educ Today. 2017 Mar;50:12-16. doi: 10.1016/j.nedt.2016.12.005. Epub 2016 Dec 16.

Reference Type RESULT
PMID: 28006699 (View on PubMed)

Doody O, Condon M. Using a simulated environment to support students learning clinical skills. Nurse Educ Pract. 2013 Nov;13(6):561-6. doi: 10.1016/j.nepr.2013.03.011. Epub 2013 Apr 18.

Reference Type RESULT
PMID: 23602694 (View on PubMed)

Posmontier B, Montgomery K, Smith Glasgow ME, Montgomery OC, Morse K. Transdisciplinary teamwork simulation in obstetrics-gynecology health care education. J Nurs Educ. 2012 Mar;51(3):176-9. doi: 10.3928/01484834-20120127-02. Epub 2012 Jan 27.

Reference Type RESULT
PMID: 22283152 (View on PubMed)

Miles DA. Simulation Learning and Transfer in Undergraduate Nursing Education: A Grounded Theory Study. J Nurs Educ. 2018 Jun 1;57(6):347-353. doi: 10.3928/01484834-20180522-05.

Reference Type RESULT
PMID: 29863735 (View on PubMed)

Cantrell ML, Meyer SL, Mosack V. Effects of Simulation on Nursing Student Stress: An Integrative Review. J Nurs Educ. 2017 Mar 1;56(3):139-144. doi: 10.3928/01484834-20170222-04.

Reference Type RESULT
PMID: 28263351 (View on PubMed)

Landeen J, Pierazzo J, Akhtar-Danesh N, Baxter P, van Eijk S, Evers C. Exploring Student and Faculty Perceptions of Clinical Simulation: A Q-Sort Study. J Nurs Educ. 2015 Sep;54(9):485-91. doi: 10.3928/01484834-20150814-02.

Reference Type RESULT
PMID: 26334334 (View on PubMed)

Guler H, Cetin P, Yurtsal ZB, Cesur B, Bekar M, Ucar T, Evcili F, Cetin A. Effect of episiotomy training with beef tongue and sponge simulators on the self-confidence building of midwifery students. Nurse Educ Pract. 2018 May;30:1-6. doi: 10.1016/j.nepr.2018.02.004. Epub 2018 Feb 9.

Reference Type RESULT
PMID: 29452943 (View on PubMed)

Other Identifiers

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Sim. Malp. Percep.

Identifier Type: -

Identifier Source: org_study_id