Effect of Simulation-Based Vaginal Examination Training on Anxiety, Confidence, and Skills in Midwifery Students (SIMVE)

April 14, 2026 updated by: Serap Ozturk Altinayak, Ondokuz Mayıs University

The Effect of Simulation-Based Vaginal Examination Training on Anxiety, Self-Confidence, and Clinical Skills in Midwifery Students

This randomized controlled quasi-experimental study investigated the effects of simulation-based vaginal examination training on skill performance, anxiety, and satisfaction in third-year midwifery students at a state university in Turkey. A total of 67 students participated (32 in the clinical group, 35 in the laboratory group). Data were collected using a Demographic Information Form, Vaginal Examination Skills Assessment Form, State Anxiety Scale, and Learning Satisfaction & Self-Confidence Scale. Results showed that simulation training significantly reduced students' state anxiety in both clinical and laboratory groups (p<0.001). Laboratory group students demonstrated significant improvements in satisfaction and self-confidence (p<0.05), while clinical group students achieved significantly higher vaginal examination skill scores compared to the laboratory group (p<0.001). No significant correlations were found between anxiety levels and satisfaction or self-confidence scores.

These findings suggest that simulation-based training effectively decreases anxiety and enhances confidence, but clinical practice is necessary to maximize technical skill acquisition. The study supports integrating simulation exercises with clinical rotations in midwifery curricula to optimize learning outcomes.

Study Overview

Detailed Description

This randomized controlled quasi-experimental study aimed to compare the effects of simulation-based vaginal examination training conducted in clinical versus laboratory environments on skill performance, anxiety, and student satisfaction among third-year midwifery students at a state university in Turkey. A total of 67 students participated, with 32 in the clinical group and 35 in the laboratory group.

Participants completed a Demographic Information Form, Vaginal Examination Skills Assessment Form, State Anxiety Scale, and Learning Satisfaction & Self-Confidence Scale. The study measured pre- and post-training levels of anxiety, satisfaction, self-confidence, and technical skills.

Results indicated a significant reduction in state anxiety scores after simulation training in both groups (45.80±7.86 to 38.08±7.80; p<0.001). Laboratory group students demonstrated a significant increase in learning satisfaction and self-confidence (p<0.05), whereas the clinical group showed significantly higher vaginal examination skill scores compared to the laboratory group (p<0.001). No significant correlation was found between anxiety and satisfaction or self-confidence scores.

These findings suggest that simulation-based education effectively reduces anxiety and enhances confidence, while clinical practice is essential for achieving higher technical skill proficiency. The results support the integration of simulation-based exercises with clinical rotations within midwifery curricula to optimize both psychological and technical learning outcomes.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Samsun
      • Samsun, Samsun, Turkey (Türkiye), 55200
        • Tokat Gaziosmanpasa University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being enrolled for the first time in the Normal Birth and Postpartum Period course during the 2022-2023 academic year,
  • Having no prior experience in performing vaginal examination,
  • Being a third-year midwifery student,
  • Volunteering to participate in the study.

Exclusion Criteria:

  • Students who were not in their third year,
  • Students who did not agree to participate or were not volunteers,
  • Students who withdrew from the study during the data collection process.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clinical Group
Students performed vaginal examination training in a real clinical setting
The group experiencing vaginal examination practice in a real clinical setting
Experimental: Laboratory Group
Students practiced vaginal examination training in a simulation laboratory environment
Simulation-based vaginal examination training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal Examination Skills Assessment Form
Time Frame: At the time of vaginal examination performance (during the simulation session)
The Vaginal Examination Skills Assessment Form is an observational tool consisting of 20 items designed to evaluate students' skills in performing vaginal examinations on a simulator in a laboratory setting. The form includes procedural steps required during the vaginal examination. Each item is scored dichotomously based on the student's performance as "performed" (5 points) or "not performed" (0 points). The total score reflects the student's level of vaginal examination skill, with higher scores indicating better performance
At the time of vaginal examination performance (during the simulation session)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State Anxiety Inventory (SAI)
Time Frame: "Before and immediately after the simulation-based training"
The State Anxiety Inventory (SAI), developed by Charles D. Spielberger and colleagues in 1964, is a Likert-type scale designed to assess state anxiety levels in both normal and clinical populations. The instrument consists of 20 items, each rated based on the intensity of feelings, thoughts, or behaviors using a 4-point scale: (1) not at all, (2) somewhat, (3) moderately, and (4) very much so. Total scores range from 20 to 80, with higher scores indicating higher levels of state anxiety.
"Before and immediately after the simulation-based training"
Simulation-Based Learning Evaluation Scale
Time Frame: Immediately after the simulation-based training
The Simulation-Based Learning Evaluation Scale was originally developed by Hung et al. (2016), and its Turkish validity and reliability were established by Uslu and Yavuz van Giersbergen (2020). The Turkish version of the scale consists of 37 items and 5 subscales. All items are positively worded and rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 37 to 185, with higher scores indicating a higher level of perceived effectiveness of simulation-based learning. No items are reverse-coded.
Immediately after the simulation-based training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

"Individual participant data will not be shared to protect participant confidentiality."

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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