NCT05672511

Brief Summary

This study was planned to evaluate the effect of simulation teaching method on the knowledge and skills of midwifery students in applying vaginal examination in labor.The study was planned as a randomized controlled trial.Research Tokat It will be held between 10.10.2022 and 10.06.2023 at Gaziosmanpaşa University Faculty of Health Sciences, Tokat Gaziosmanpaşa University Health Research and Application Hospital and Tokat Provincial Health Directorate Tokat State Hospital.The population of the research will consist of students (N=102) who are students of Tokat Gaziosmanpaşa University Health Sciences Faculty Midwifery Department, who took the Normal Birth and Postpartum Period course for the first time in the 2022-2023 academic year, and who have not had a vaginal examination before. The sample of the randomized controlled study was calculated in the G\*Power 3.1 program . Accordingly, the number of samples to be included in the study for an error margin of 0.05 with a statistical power of 80% was calculated as n= 51 for the experimental group and n= 51 for the control group for each group.The Effect of Simulation Teaching Method on Midwifery Students' Knowledge and Skills of Applying Vaginal Examination in Labor: The Randomized Controlled Study Questionnaire consists of four parts.Randomly determined experimental group students will perform eight vaginal examination scenarios different in terms of cervical effacement, cervical dilatation, presence of amniotic membrane, presenting fetus part, position of the fetus and fetal descent on the fetal monitoring and labor progress model set in the laboratory. The control group will not receive any simulation training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

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

August 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

January 3, 2023

Last Update Submit

January 30, 2024

Conditions

Keywords

Vaginal ExaminationKnowledgeSkillSimulationTeaching

Outcome Measures

Primary Outcomes (1)

  • List of skills for students to perform vaginal examination practice steps

    This is the section where the skills of the students in performing the vaginal examination application steps (22 items) prepared by the researchers by examining the literature are evaluated. The items will be evaluated by the researchers as they did or did not. The first vaginal examination on the woman in the clinic will be filled in both groups before the application.

    baseline

Study Arms (2)

İntervention group

EXPERIMENTAL

Randomly determined experimental group students will perform eight vaginal examination scenarios different in terms of cervical effacement, cervical dilatation, presence of amniotic membrane, presenting fetus part, position of the fetus and fetal descent on the fetal monitoring and labor progress model set in the laboratory.

Behavioral: Simulation Teaching Method

Control group

NO INTERVENTION

. The control group will not receive any simulation training

Interventions

Randomly determined experimental group students will perform eight vaginal examination scenarios different in terms of cervical effacement, cervical dilatation, presence of amniotic membrane, presenting fetus part, position of the fetus and fetal descent on the fetal monitoring and labor progress model set in the laboratory. The control group will not receive any simulation training. Both groups will be given a knowledge test after teaching with simulation. Students in both groups will fill out a form evaluating their skills in performing the steps of vaginal examination before each vaginal examination is performed on women in the clinic.

İntervention group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • who took the Normal Birth and Postpartum Period course for the first time in the 2022-2023 academic year, and who have not had a vaginal examination before.

You may not qualify if:

  • Those who have done 5 or more vaginal examinations on real pregnant women before.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpasa University, Faculty of Health Sciences, Midwifery Department

Tokat Province, Turkey/Tokat, 60250, Turkey (Türkiye)

Location

Related Publications (14)

  • Pratinidhi, A., Patange, R., Patil, S., Salunkhe, J., & Samson, S. (2014). Testing of simulation training device for assessment of cervical dilatation among nursing student of Karad, India

    BACKGROUND
  • Muliira RS, Seshan V, Ramasubramaniam S. Improving vaginal examinations performed by midwives. Sultan Qaboos Univ Med J. 2013 Aug;13(3):442-9. Epub 2013 Jun 25.

    PMID: 23984031BACKGROUND
  • Huhn KA, Brost BC. Accuracy of simulated cervical dilation and effacement measurements among practitioners. Am J Obstet Gynecol. 2004 Nov;191(5):1797-9. doi: 10.1016/j.ajog.2004.07.062.

    PMID: 15547567BACKGROUND
  • Arias T, Tran A, Breaud J, Fournier JP, Bongain A, Delotte J. A prospective study into the benefits of simulation training in teaching obstetric vaginal examination. Int J Gynaecol Obstet. 2016 Jun;133(3):380-4. doi: 10.1016/j.ijgo.2015.08.028. Epub 2016 Feb 23.

    PMID: 26971257BACKGROUND
  • Chahine, E. B., Rizk, S., Young, M., Moynihan, A., Arluck, J., & Walker, P. (2018). Intern Bootcamp Cervical Dilation Simulation: Findings and Assessment [34M]. Obstetrics & Gynecology, 131, 150S.

    BACKGROUND
  • Roosevelt L, Diebel M, Zielinski RE. Achieving competency in vaginal examinations: The challenge of balancing student learning needs with best practice in maternity care. Midwifery. 2018 Jun;61:39-41. doi: 10.1016/j.midw.2018.02.016. Epub 2018 Feb 23.

    PMID: 29524775BACKGROUND
  • Cass GK, Crofts JF, Draycott TJ. The use of simulation to teach clinical skills in obstetrics. Semin Perinatol. 2011 Apr;35(2):68-73. doi: 10.1053/j.semperi.2011.01.005.

    PMID: 21440813BACKGROUND
  • Bastable, S. B. (2017). Nurse as educator: Principles of teaching and learning for nursing practice. jones & bartlett learning.

    BACKGROUND
  • Aslan, M. Günay, O. Çetinkaya, F. Mazıcıoğlu, M., (2002). Tıp Eğiticileri İçin Eğitim Becerileri Rehberi. Erciyes Üniversitesi Tıp Fakültesi, Yayın No:70, 80-88, Kayseri.

    BACKGROUND
  • McEwen BS, Sapolsky RM. Stress and cognitive function. Curr Opin Neurobiol. 1995 Apr;5(2):205-16. doi: 10.1016/0959-4388(95)80028-x.

    PMID: 7620309BACKGROUND
  • Nitsche JF, Shumard KM, Fino NF, Denney JM, Quinn KH, Bailey JC, Jijon R, Huang C, Kesty K, Whitecar PW, Grandis AS, Brost BC. Effectiveness of Labor Cervical Examination Simulation in Medical Student Education. Obstet Gynecol. 2015 Oct;126 Suppl 4:13S-20S. doi: 10.1097/AOG.0000000000001027.

    PMID: 26375554BACKGROUND
  • Driscoll, Mp., (2005). Pyschology of Learning for İnstruction, 3rd Ed. New York: Pearson.

    BACKGROUND
  • Tiffen, J. Graf, N. Corbridge, S., (2009). Effectiveness of a Low-Fidelity Simulation Experience in Building Confidence Among Advanced Practice Nursing Graduate Students. Clinical Simulation in Nursing, 5(3), 113-117

    BACKGROUND
  • Abbas, A., Shaltout, A., & Fathalla, M. (2019). The Merit of Simulation in Teaching Medical Interns Vaginal Examination on Laboring Women. American Journal of Obstetrics And Gynecology, 220(1).

    BACKGROUND

Study Officials

  • Döndü BATKIN ERTÜRK

    Midwifery

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Proffesor Dr

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 5, 2023

Study Start

August 1, 2022

Primary Completion

November 15, 2023

Study Completion

December 15, 2023

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations