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NCT Number: NCT07535255

Effect of Simulation-Based Vaginal Examination Training on Anxiety, Confidence, and 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.

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Key information

Conditions

Simulation-based Midwifery Education Anxiety Disorders Behavior Mental Disorders Personal Satisfaction

Age range

20 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tokat Gaziosmanpaşa University

Samsun, 55200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

educational

Other

Simulation-based vaginal examination training

The group experiencing vaginal examination practice in a real clinical setting

Other

The group experiencing vaginal examination practice in a real clinical setting

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Acronym: SIMVE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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