Simulation-based Midwifery EducationSIMVENCT07535255
Effect of Simulation-Based Vaginal Examination Training on Anxiety, Confidence, and Skills in Midwifery Students
A study testing Educational and The group experiencing vaginal examination practice in a real clinical setting in people with Simulation-based Midwifery Education, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Simulation-based Midwifery Education
- What is being tested?
- Educational and The group experiencing vaginal examination practice in a real clinical setting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 1 Dec 2023
- 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 20 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpaşa University
Samsun, Samsun, 55200
About this study
Official title: 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.
Read the 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.
- Conditions
- Simulation-based Midwifery Education
- Being tested
- Educational, The group experiencing vaginal examination practice in a real clinical setting
- Keywords
- Vaginal examination, Simulation training, Learning environment, Skill, Anxiety, Satisfaction
- Medical subject headings
- Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationalOther
Simulation-based vaginal examination training
The group experiencing vaginal examination practice in a real clinical settingOther
The group experiencing vaginal examination practice in a real clinical setting
| Study group | Role | What they receive |
|---|---|---|
| Clinical Group | Experimental | Students performed vaginal examination training in a real clinical setting Receives: Other: The group experiencing vaginal examination practice in a real clinical setting |
| Laboratory Group | Experimental | Students practiced vaginal examination training in a simulation laboratory environment Receives: Other: Educational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal Examination Skills Assessment Form
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
Measured: At the time of vaginal examination performance (during the simulation session)
Secondary outcomes (2)
State Anxiety Inventory (SAI)
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.
Measured: "Before and immediately after the simulation-based training"
Simulation-Based Learning Evaluation Scale
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.
Measured: Immediately after the simulation-based training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Sep 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simulation-based Midwifery EducationStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two parallel groups: a clinical group, where students performed vaginal examination training in a real clinical setting, and a laboratory group, where students practiced in a simulation laboratory environment. Both groups received the same simulation-based training, and pre- and post-intervention measures of anxiety, skill performance, satisfaction, and self-confidence were collected.
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Ozturk Altinayak, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535255
- Sponsor's protocol ID
- OMÜ-KAEK-2022/296
- Acronym
- SIMVE
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: "Individual participant data will not be shared to protect participant confidentiality."
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation-Based Vaginal Examination Training on Anxiety, Self-Confidence, and Clinical Skills in Midwifery Students
- ClinicalTrials.gov ID
- NCT07535255
- Acronym / sponsor ID
- SIMVE / OMÜ-KAEK-2022/296
- Conditions
- Simulation-based Midwifery Education
- Keywords
- Vaginal examination, Simulation training, Learning environment, Skill, Anxiety, Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups: a clinical group, where students performed vaginal examination training in a real clinical setting, and a laboratory group, where students practiced in a simulation laboratory environment. Both groups received the same simulation-based training, and pre- and post-intervention measures of anxiety, skill performance, satisfaction, and self-confidence were collected.
| Arm | Type | Receives |
|---|---|---|
| Clinical Group | Experimental | Other: The group experiencing vaginal examination practice in a real clinical settingStudents performed vaginal examination training in a real clinical setting |
| Laboratory Group | Experimental | Other: EducationalStudents practiced vaginal examination training in a simulation laboratory environment |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationalSimulation-based vaginal examination training | Other | Laboratory Group |
| The group experiencing vaginal examination practice in a real clinical settingThe group experiencing vaginal examination practice in a real clinical setting | Other | Clinical Group |
Primary outcome
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
2 secondary outcomes
State Anxiety Inventory (SAI)
Time frame: "Before and immediately after the simulation-based training"
Simulation-Based Learning Evaluation Scale
Time frame: Immediately after the simulation-based training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No. "Individual participant data will not be shared to protect participant confidentiality."
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational and The group experiencing vaginal examination practice in a real clinical setting in people with Simulation-based Midwifery Education, run by Ondokuz Mayıs 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 4 inclusion and 3 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 17 Apr 2026. 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?
Vaginal Examination Skills Assessment Form (time frame: At the time of vaginal examination performance (during the simulation session)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2026.