NCT05971927

Brief Summary

This study was planned to evaluate the effect of simulation teaching method on the ability to apply vaginal examination in labor and self-confidence in midwifery students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

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

December 12, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
Last Updated

August 3, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

July 17, 2023

Last Update Submit

August 2, 2023

Conditions

Keywords

Midwifery studentVaginal examinationConfidenceSkillSimulation

Outcome Measures

Primary Outcomes (7)

  • Students' self-confidence ratings in performing the vaginal examination application steps

    I am not at all confident-1 I am not confident-2 I have little confidence in myself-3 I am confident-4 I am very confident-5 In the analysis of students' self-confidence in performing the vaginal examination practice steps, the categories of "I am not at all confident", "I am not confident" and "I have little confidence in myself" were combined as "low self-confidence", while the categories of "I am confident" and "I am very confident" were combined as "high self-confidence". Each step was evaluated separately.

    At the beginning of the study

  • Students' self-confidence ratings in performing the vaginal examination application steps

    I am not at all confident-1 I am not confident-2 I have little confidence in myself-3 I am confident-4 I am very confident-5 In the analysis of students' self-confidence in performing the vaginal examination practice steps, the categories of "I am not at all confident", "I am not confident" and "I have little confidence in myself" were combined as "low self-confidence", while the categories of "I am confident" and "I am very confident" were combined as "high self-confidence". Each step was evaluated separately.

    Within 1-6 months after the start of the study

  • Cervical effacement

    as a percentage (accurate and wrong)

    Within 1-6 months after the start of the study

  • Cervical dilatation

    in centimeters (accurate and wrong)

    Within 1-6 months after the start of the study

  • Presenting fetal part

    head, breech etc. (accurate and wrong)

    Within 1-6 months after the start of the study

  • Presence of amniotic membrane

    intact or ruptured (accurate and wrong)

    Within 1-6 months after the start of the study

  • Fetal descent

    -3,-2,-1,0,+1,+2,+3 (accurate and wrong)

    Within 1-6 months after the start of the study

Study Arms (2)

Experimental group

EXPERIMENTAL

Simulation education

Behavioral: Simulation education

Control groups

NO INTERVENTION

The control group did not receive any simulation training.

Interventions

Randomly assigned experimental group students performed eight different vaginal examination scenarios in the laboratory on the fetal monitoring and labor progress model set for cervical dilatation, cervical effacement, presenting fetal part, presence of amniotic membrane and fetal descent. The researchers repeated the vaginal examination scenario and informed the students about the evaluation results after each student had performed the vaginal examination scenario prepared by the researchers. This process continued until the experimental group students completed eight different vaginal examination scenarios.

Experimental group

Eligibility Criteria

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

You may qualify if:

  • Midwifery students enrolled in Normal Birth and Postpartum Term Course in the 2019-2020 academic year

You may not qualify if:

  • Students who did not volunteer to participate in the study
  • Students who did not perform vaginal examination on real women at the clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, 60250, Turkey (Türkiye)

Location

Related Publications (14)

  • 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
  • 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
  • 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
  • https://www.internationalmidwives.org/assets/files/general-files/2019/10/icm-competencies-en-print-october-2019_final_18-oct-5db05248843e8.pdf erişim tarihi: 15.11.2019

    BACKGROUND
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctoral lecturer

Study Record Dates

First Submitted

July 17, 2023

First Posted

August 2, 2023

Study Start

December 12, 2019

Primary Completion

March 13, 2020

Study Completion

March 13, 2020

Last Updated

August 3, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations