NCT07535255

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

April 6, 2026

Last Update Submit

April 14, 2026

Conditions

Keywords

Vaginal examination, Simulation training, Learning environment, Skill, Anxiety, Satisfaction

Outcome Measures

Primary Outcomes (1)

  • 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

    At the time of vaginal examination performance (during the simulation session)

Secondary Outcomes (2)

  • State Anxiety Inventory (SAI)

    "Before and immediately after the simulation-based training"

  • Simulation-Based Learning Evaluation Scale

    Immediately after the simulation-based training

Study Arms (2)

Clinical Group

EXPERIMENTAL

Students performed vaginal examination training in a real clinical setting

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

Other: Educational

Interventions

Simulation-based vaginal examination training

Laboratory Group

The group experiencing vaginal examination practice in a real clinical setting

Clinical Group

Eligibility Criteria

Age20 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpaşa University

Samsun, Samsun, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPersonal Satisfaction

Condition Hierarchy (Ancestors)

Mental DisordersBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 6, 2026

First Posted

April 17, 2026

Study Start

September 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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

Locations