- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07535255
Effect of Simulation-Based Vaginal Examination Training on Anxiety, Confidence, and Skills in Midwifery Students (SIMVE)
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Samsun
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Samsun, Samsun, Turkey (Türkiye), 55200
- Tokat Gaziosmanpasa University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMÜ-KAEK-2022/296
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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