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Vaginal ExaminationNCT05971927

Simulation Teaching Method and Vaginal Examination in Midwifery Students

A study testing Simulation education in people with Vaginal Examination, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Vaginal Examination
What is being tested?
Simulation education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteTurkey (Türkiye)
Study dates
12 Dec 2019to 13 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Tokat Gaziosmanpasa University

    Tokat Province, 60250

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Simulation Teaching Method on Vaginal Examination Practice Skills and Self-Confidence Development in Labor in Midwifery Students

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.

Read the detailed description

Two skills, abdominal palpation and vaginal examination, are used to clinically monitor the progress of labor. Vaginal examination is the most accepted method to measure the progress of labor.Vaginal examination, which is routinely applied in the evaluation of labor progress, is an important part of midwifery care. However, it is reported that the accuracy level of vaginal examination for new students is low. This essential skill is a learned tactile/tactile skill that requires consistency to properly manage women in labor. Therefore, it cannot be learned through observation alone; In order to acquire this skill, students need to perform a large number of vaginal examinations in women who have given birth. The usual/classic training technique for teaching vaginal examination is that the midwifery student performs a vaginal examination on the woman in labor under the supervision of an experienced obstetrician, and then the experienced obstetrician repeats this examination to determine the accuracy of the trainee student's assessment. Simulation-based learning improves the understanding, retention and active use of knowledge and skills, reduces the student's pre-application anxiety, and increases self-confidence. It is seen that simulation, which has been widely used in medical education in recent years, is also used as a teaching method in the development of practice skills of midwifery students.There are several studies in the literature evaluating the effect of simulation training on students' vaginal examination skills and self-confidence.In a study conducted to evaluate the benefits of simulation training in teaching obstetric vaginal examination techniques to medical students, it was found that the vaginal examination accuracy of students who received simulation training was significantly higher than those who did not receive simulation training. In this study, it was concluded that simulation training helped inexperienced students improve their vaginal examination skills before performing such procedures on real patients, interns who performed simulated examination showed significantly higher accuracy in vaginal examination evaluations than the control group. However, according to the available data, no study has been found that examines the effect of simulation training on vaginal examination skills in midwifery students.

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.

Type of Study: The study was planned as a randomized controlled trial.

Place and Time of the Research: The research was carried out at Tokat Gaziosmanpaşa University Faculty of Health Sciences, Tokat Gaziosmanpaşa University Health Research and Application Hospital and Tokat Provincial Health Directorate Tokat State Hospital between 10.02.2020-17.05.2020.

Population and Sample of the Research:

The universe of the research consisted of 66 students who took the Normal Birth and Postpartum Period and Risky Birth and Postpartum Period course for the first time in the Department of Midwifery, Faculty of Health Sciences, Tokat Gaziosmanpaşa University.

Students who agreed to participate in the study voluntarily were included in the study.

66 midwifery students forming the research sample were ranked from high to low according to their general academic grade point average. After the group with the highest grade point average was determined randomly (by drawing lots), the students were assigned to the experimental and control groups, respectively.

Data Collection Tools

The Effect of Simulation Teaching Method on Vaginal Examination Practice Skills and Self-Confidence Development in Midwifery Students Questionnaire The questionnaire consists of three parts.

  1. Socio-demographic characteristics of students

In this section, midwifery students' age, marital status, graduated school, family structure, place of residence, education level of the mother and father, perception of income, where the family lives, the presence of health personnel in the family members, their position, if any, their satisfaction with the midwifery department. There are a total of 18 questions about how they evaluate the difference between the preference order of the midwifery profession, the general academic grade point average, the level of finding sufficient theoretical knowledge and skills in vaginal examination, previous vaginal examination practice and examination findings, and the findings of an experienced obstetrician.

  1. Students' self-confidence ratings on performing the vaginal examination application steps This is the section in which the students rank their self-confidence in performing the vaginal examination application steps (22 items) prepared by the researchers by examining the literature. It is scored as I do not trust myself at all-1, I do not trust myself-2, I have little confidence in myself-3, I have confidence in myself-4, I am very confident in myself-5.C. Vaginal examination evaluation results of the students in the clinic
  2. Vaginal examination evaluation results of the students in the clinic This is the section where the evaluation results (cervical effacement, cervical dilatation, presence of amniotic membrane, presenting fetus part and fetal descent) of the midwifery student and experienced health professional (midwife, nurse and doctor) in vaginal examinations performed on women in the clinic for both groups are recorded.

Application of the Research:

All students who took the Normal Birth and Postpartum Period and Risky Birth and Birth and Postpartum Period courses were given a theoretical lecture on the steps of vaginal examination in labor and the criteria to be evaluated in vaginal examination, and a video on the subject was watched.

After giving information about the study, informed consent was obtained from all students who voluntarily agreed to participate in the study.

The students were asked to fill in the questionnaires prepared by the researchers, examining the socio-demographic characteristics and vaginal examination experiences of the students, and to rate their self-confidence in performing the vaginal examination application steps.

The experimental group students, which were determined as random, performed eight different vaginal examination scenarios on the fetal monitoring and labor progress model set in terms of cervical effacement, dilatation and the presence of the presenting part and amniotic sac.

The control group did not receive any simulation training.

The students in both groups were asked to rate their self-confidence in performing the steps of performing the vaginal examination for the second time before performing the first vaginal examination on the woman in the clinic.

Vaginal examination results (cervical effacement, cervical dilatation, presence of amniotic membrane, presenting fetus part, and fetal descent) of the midwifery student and experienced health professional (midwife, nurse and doctor) were recorded in the vaginal examinations performed on women in the clinic for both groups.

In this study, the vaginal examination procedure normally used by midwifery students during their professional practice in health institutions was used.

An experienced health professional performed the vaginal examination in the woman in labor, then the midwifery student repeated the vaginal examination on the same woman under the supervision of an experienced health professional and the evaluation findings were compared.

Informed consent was obtained from the women before the vaginal examination, infection control measures were taken during the examinations (hand washing, wearing sterile gloves and avoiding frequent vaginal examinations), and the privacy of the women was respected as much as possible. The findings of experienced health professionals were accepted as the gold standard in the study. Student findings consistent with the findings of the experienced healthcare professional were evaluated as correct, and student findings that were not compatible with or could not be evaluated with the findings of the experienced healthcare professional were evaluated as incorrect.

Evaluation of Research Data:

Descriptive statistics were calculated to give information about the general characteristics of the research groups. Qualitative data were expressed as percentages and compared using the Chi-Square Test or the Fisher Exact Test. Quantitative data were expressed as mean±standard deviation, and were compared using the Independent Two-Group T-Test. P<0.05 was considered statistically significant. Calculations were made with ready-made statistical software.

Ethical Aspect of Research:

Institutional permission from Tokat Gaziosmanpaşa University Faculty of Health Sciences, Tokat Gaziosmanpaşa University Health Research and Application Hospital and Tokat Provincial Health Directorate Tokat State Hospital and Tokat Gaziosmanpaşa University Clinical Research Ethics Committee approval were obtained for the research. Informed consent was obtained from all participants (midwifery students and women in labor) who would participate in the study.

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

-Vaginal examination evaluation parameters (cervical effacement, cervical dilatation, presence of amniotic membrane, presenting fetus part and fetal descent)

Being tested
Simulation education
Keywords
Midwifery student, Vaginal examination, Confidence, Skill, Simulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simulation educationBehavioural

    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.

Study groups in NCT05971927
Study groupRoleWhat they receive
Experimental groupExperimentalSimulation education
Receives: Behavioral: Simulation education
Control groupsNo interventionThe control group did not receive any simulation training.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At the beginning of the study

  2. 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.

    Measured: Within 1-6 months after the start of the study

  3. Cervical effacement

    as a percentage (accurate and wrong)

    Measured: Within 1-6 months after the start of the study

  4. Cervical dilatation

    in centimeters (accurate and wrong)

    Measured: Within 1-6 months after the start of the study

  5. Presenting fetal part

    head, breech etc. (accurate and wrong)

    Measured: Within 1-6 months after the start of the study

  6. Presence of amniotic membrane

    intact or ruptured (accurate and wrong)

    Measured: Within 1-6 months after the start of the study

  7. Fetal descent

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

    Measured: Within 1-6 months after the start of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2023
  2. Study start12 Dec 2019
  3. Primary completion13 Mar 2020
  4. Study completion13 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05971927
Sponsor's protocol ID
TOKAT02
Status last verified
Jul 2023
First submitted
17 Jul 2023
Last updated
3 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23984031
  • 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.

  • 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.

  • 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

  • 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.

    PubMed 26971257
  • 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.

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

  • 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.

  • Bourne, LE. Jr. Yaraush RA., (1995). Stress And Cognition: A Cognitive Psychological Perspective. Current Opinion in Neurobiology, 5(2), 205-216.

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

  • 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

  • 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.

    PubMed 26375554
  • 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.

    PubMed 29524775
  • 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).

Questions about this trial

What is this clinical trial studying?

A study testing Simulation education in people with Vaginal Examination, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Students' self-confidence ratings in performing the vaginal examination application steps (time frame: At the beginning of the study). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05971927, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023; AzTrials last refreshed its copy on 30 Oct 2026.

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