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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04656574
Other study ID # Sim. Malp. Percep.
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 26, 2016
Est. completion date September 18, 2017

Study information

Verified date December 2020
Source Kutahya Medical Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date September 18, 2017
Est. primary completion date January 7, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Kutahya Health Science University Kutahya
Turkey Kutahya Health Science University Kutahya

Sponsors (1)

Lead Sponsor Collaborator
Aysegul Durmaz

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

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. Review. — View Citation

Dearnley CA, Meddings FS. Student self-assessment and its impact on learning - a pilot study. Nurse Educ Today. 2007 May;27(4):333-40. Epub 2006 Jul 25. — View Citation

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. — View Citation

Guler H, Cetin P, Yurtsal ZB, Cesur B, Bekar M, Uçar 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.2 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary medical malpractice tendency 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 monitiring and material-device safety, prevention of falls, and communication. 2 week after the intervention
Primary Perceptions of care behaviors 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 Acaroglu (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
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