NCT06536192

Brief Summary

Vaginal, abdominal, and breast examinations are among the essential gynecological examination skills for midwifery students and are crucial steps that need to be learned. However, due to the privacy of genital areas, there are some debates regarding the teaching of these skills. Low-fidelity mannequins and models are particularly effective and cost-efficient in acquiring basic psychomotor skills. Thus, midwifery students can gain clinical experience, make mistakes in a safe environment, and enhance their skills. The sample of this study consists of 64 midwifery students (experimental=32, control=32) using a pre-test, post-test design with an observational randomized controlled trial. Data collection instruments include a Personal Information Form (PIF), Learner's Guide (LG), Self-Confidence Scale (SCS), and Self-Confidence in Learning Scale (SSSCLS. In the experimental group, after providing theoretical knowledge, students will receive practical training on a gynecological examination model, including bimanual examination, vaginal examination with a speculum, pap smear for cervical screening, and pelvic palpation. Each student will then perform the examination individually, with approximately 15 minutes allocated per student. Two weeks later, the same students will be asked to perform all examination steps again. During the examinations, the researcher will mark complete and incomplete procedures in the learner's guide, and any deficiencies will be explained to the students for completion. The CS and SSSLS will be administered for the post-test. In the control group, after theoretical knowledge is provided, students will be shown visual and video demonstrations of the steps of a gynecological examination. The PIF and SCS will be administered for the pre-test, and two weeks later, students will be asked to perform the examination steps in a laboratory setting, followed by the post-test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

July 22, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
23 days until next milestone

Study Start

First participant enrolled

August 25, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2025

Completed
Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

July 22, 2024

Last Update Submit

February 3, 2025

Conditions

Keywords

Midwife, student, gynecological examination, model

Outcome Measures

Primary Outcomes (1)

  • Improving gynecological examination skills with the use of a model

    Gynecologic Disease

    Groups of 5 people receive 15 minutes of laboratory training and 15 days later, practice in the laboratory.

Study Arms (2)

Intervention (Model) group

EXPERIMENTAL

1. Process: Theoretical knowledge will be given to students, and then different types of gynecological examinations will be explained practically on a model in the laboratory environment. 2. Process: The learner guide will be filled out. 3. Process: After 15 days, students will be taken back to the laboratory environment to fill out the learner guide again. In addition, Self-Confidence Scale (SCS) and Student Satisfaction and Self-Confidence in Learning Scale (SSSLS) will be filled out for the last exam.

Other: Model group

Control group

NO INTERVENTION

1. Procedure: The stages of gynecological examination evaluation for students, its purpose, the process of preparing the patient and evaluating them will be provided with theoretical knowledge. 2. Procedure: Pre-tests will be administered. 3. Procedure: Two weeks later, Self-Confidence Scale (SCS); Learner's Guide (LG) and (Student Satisfaction and Self-Confidence in Learning Scale) SSSCLS will be filled out for the final test.

Interventions

1. Process: Theoretical knowledge will be given to students, and then different types of gynecological examinations will be explained practically on a model in the laboratory environment. 2. Process: The learner guide will be filled out. 3. Process: After 15 days, students will be taken back to the laboratory environment to fill out the learner guide again. In addition, SCS and SSSLS will be filled out for the last exam.

Intervention (Model) group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being a 3rd or 4th year midwifery student at Karabük University Faculty of Health Sciences
  • Being between the ages of 18-25
  • Voluntarily agreeing to participate in the study
  • Being a citizen of the Republic of Turkey

You may not qualify if:

  • Leave whenever you want without working.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karabük University

Karabük, Karabük Province, 78050, Turkey (Türkiye)

Location

Ayşe Çuvadar

Karabük, Turkey, 78050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HypersensitivityGenital Diseases, Female

Condition Hierarchy (Ancestors)

Immune System DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 22, 2024

First Posted

August 2, 2024

Study Start

August 25, 2024

Primary Completion

December 30, 2024

Study Completion

February 3, 2025

Last Updated

February 5, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations