NCT07260929

Brief Summary

This randomized controlled trial aims to evaluate the effectiveness of a virtual reality (VR)-based training model supported by VR goggles in improving basic clinical skills among midwifery students. Traditional skills training in midwifery education can be limited by time, instructor availability, and opportunities for repeated practice. VR technology offers an immersive, standardized, and repeatable learning environment that may enhance skill development and learner engagement. In this study, midwifery students will be randomly assigned to either the VR training group or the traditional training group. Participants in the VR group will practice selected basic clinical skills using a VR goggle-supported simulation model, while the control group will receive standard skills laboratory training. Both groups will be evaluated through objective structured clinical examinations (OSCEs), self-confidence scales, and skill performance checklists. The study aims to determine whether VR-enhanced training improves clinical skill acquisition, performance accuracy, and learner confidence compared with traditional methods. Findings from this research may help inform modern, technology-supported approaches to midwifery education.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

November 21, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

November 21, 2025

Last Update Submit

April 15, 2026

Conditions

Keywords

Midwifery educationclinical skills trainingvirtual reality-based learningsimulation-based training

Outcome Measures

Primary Outcomes (1)

  • Improvement in Basic Midwifery Clinical Skills Performance

    Performance in core midwifery clinical skills (e.g., abdominal examination, Leopold maneuvers, vital signs assessment, hand hygiene, perineal care, and communication skills) will be evaluated using a validated Objective Structured Clinical Examination (OSCE) checklist. Higher scores indicate better skill performance. Student satisfaction and self-confidence in learning will be evaluated using the "Student Satisfaction and Self-Confidence in Learning Scale," which consists of 13 items rated on a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 13 (minimum) to 65 (maximum), and higher scores indicate greater satisfaction with the instructional experience and higher self-confidence in learning.

    Baseline (pre-training) and immediately post-training (within 1 week after completion of the training program)

Study Arms (2)

Experimental (VR Goggle-Assisted VR Training)

EXPERIMENTAL

Participants in this arm will receive basic clinical skills training using a VR goggle-supported virtual reality model specifically designed for midwifery education. The VR module includes interactive simulations, step-by-step procedural guidance, and scenario-based skill practice. Training will be delivered individually under supervision and will cover essential midwifery clinical skills.

Behavioral: VR Goggle-Assisted Simulation Training

Active Comparator: Traditional Training

ACTIVE COMPARATOR

Participants in this arm will receive traditional basic clinical skills training using standard educational methods such as demonstration, skills laboratory practice, and return demonstration. This training follows the current curriculum used in midwifery clinical skills education and does not include virtual reality components.

Behavioral: Standard Clinical Skills Training

Interventions

The VR-based training intervention includes an immersive Virtual Reality clinical skills module delivered through VR goggles. Participants receive structured, scenario-based training covering basic midwifery clinical skills, such as hand hygiene, aseptic technique, vital signs assessment, perineal care, and safe birth positioning. Each session is conducted using interactive 3D simulations that allow learners to observe, practice, and repeat psychomotor and decision-making steps in a risk-free virtual environment. The training is standardized across participants, lasts approximately 30 minutes per session, and is delivered by an instructor trained in VR-assisted education.

Experimental (VR Goggle-Assisted VR Training)

Participants in this Arm will receive standard midwifery basic clinical skills training through conventional laboratory practice without VR exposure. Training content follows the curriculum guidelines and emphasizes hands-on skill development using standard educational materials and instructor demonstrations.

Active Comparator: Traditional Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently enrolled as an undergraduate midwifery student at Gaziantep University.
  • Registered in or scheduled to take the "Basic Clinical Skills" course during the study period.
  • Aged 18 years or older.
  • Able to provide informed consent and willing to participate throughout the study.
  • Has no previous formal training with virtual reality (VR) simulation related to midwifery clinical skills.
  • Able to use VR goggles safely (no known conditions that prevent VR use, such as severe motion sickness).

You may not qualify if:

  • A diagnosed visual, neurological, or vestibular disorder that may interfere with VR use (e.g., epilepsy, severe vertigo).
  • A history of severe motion sickness symptoms triggered by digital screens or VR environments.
  • Participated previously in a pilot version of the VR training module.
  • Currently taking a leave of absence or not actively attending coursework.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University

Gaziantep, Gaziantep, 27310, Turkey (Türkiye)

Location

Study Design

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

Study Record Dates

First Submitted

November 21, 2025

First Posted

December 3, 2025

Study Start

December 1, 2025

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations