NCT04656574

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2017

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
Last Updated

December 7, 2020

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

November 28, 2020

Last Update Submit

December 4, 2020

Conditions

Keywords

EpisiotomyMedical MalpracticePerceptionsSimulationVaginal Childbirth

Outcome Measures

Primary Outcomes (2)

  • 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 monitıring and material-device safety, prevention of falls, and communication.

    2 week after the intervention

  • 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 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

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Behavioral: Simulation-based training

Control Group

NO INTERVENTION

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

Interventions

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.

Experimental Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kutahya Health Science University

Kütahya, 43000, Turkey (Türkiye)

Location

Kutahya Health Science University

Kütahya, Turkey (Türkiye)

Location

Related Publications (9)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Behavior

Study Officials

  • Aysegul Durmaz

    KSBU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants didn't know which group they were allocated. The participants will be blind when they receive simulation based training from researcher.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

November 28, 2020

First Posted

December 7, 2020

Study Start

September 26, 2016

Primary Completion

January 7, 2017

Study Completion

September 18, 2017

Last Updated

December 7, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Starting 6 months after publication
Access Criteria
If study IPD is used, my article should be cited.

Locations