NCT07238205

Brief Summary

The aim of this educational research is to determine whether a mixed reality-based training program is effective in teaching midwifery students how to assess cervical effacement and dilation. The study also examines the impact of mixed reality on students' cognitive load, sense of presence, and midwifery professional perception. The main questions the study seeks to answer are: Does mixed reality training reduce students' cognitive load? Does mixed reality increase the students' sense of presence? How does mixed reality-based training influence students' professional perception of midwifery? Do students who receive mixed reality training perform better in assessing cervical effacement and dilation on real pregnant women compared with the control group?

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

September 12, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

September 12, 2025

Last Update Submit

November 15, 2025

Conditions

Keywords

Cervical DilatationLaborFirst Stage

Outcome Measures

Primary Outcomes (2)

  • Accuracy of Cervical Dilation Measurement (cm)

    Accuracy of cervical dilation measurement will be assessed by calculating the absolute difference (in centimeters) between the student's measurement and the researcher's reference measurement. Each participant will perform one vaginal examination on five different pregnant women. The mean absolute difference across all five assessments will be reported as the participant's cervical dilation measurement accuracy. Smaller values indicate higher accuracy.

    4 month

  • Accuracy of Cervical Effacement Measurement (%)

    Cervical effacement accuracy will be assessed by calculating the absolute difference (in percentage points) between the student's effacement measurement and the researcher's reference measurement. Each participant will perform one vaginal examination on five different pregnant women. The mean absolute difference across all five assessments will be reported as the participant's cervical effacement measurement accuracy. Smaller values indicate higher accuracy.

    4 month

Secondary Outcomes (3)

  • Assessment of Cognitive Load

    4 months

  • Assessment of Presence Experience

    Immediately after MR training (within 1 day)

  • Assessment of Midwifery Professional Perception

    4 months

Study Arms (2)

Mixed Reality Training Group

EXPERIMENTAL

Students will participate in a mixed reality (MR)-based training program.

Other: mixed reality education

Standard Education Group

ACTIVE COMPARATOR

Students in the control group will receive traditional theoretical instruction.

Other: Standard Education Group

Interventions

Students will participate in a mixed reality (MR)-based training program. The program is designed to teach cervical effacement and dilation assessment. During the training, students will interact with three-dimensional virtual cervical models. They will be able to practice repeatedly in a safe, error-free environment to enhance their clinical skills. After completing MR training, students will perform vaginal examinations on 10 virtual patient scenarios. The accuracy of each assessment will be automatically evaluated by the system. Following MR training, students will conduct vaginal examinations on five pregnant women under researcher supervision in a real clinical setting. The following scales will be administered to participants: Cognitive Load Scale Sense of Presence Scale Midwifery Professional Perception Scale These measures will be used to determine the cognitive and professional effects of MR-based learning.

Mixed Reality Training Group

Students in the control group will receive traditional theoretical instruction. The training content will cover the principles of cervical effacement and dilation assessment. After completing the theoretical training, students will complete the Cognitive Load Scale and the Midwifery Professional Perception Scale. Under researcher supervision, students will perform vaginal examinations on five pregnant women to assess cervical effacement and dilation. These evaluations will be used to examine the effects of traditional training on students' cognitive load, professional perception, and practical assessment skills.

Standard Education Group

Eligibility Criteria

Age18 Months - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Enrolled in the Midwifery Department at Mardin Artuklu University,
  • Taking the course "Normal Birth and Postpartum Care,"
  • Who have not previously received any structured training (practical training, simulation, etc.) related to vaginal examination or cervical dilation/effacement procedures,
  • Who do not feel confident in assessing cervical effacement and dilation,
  • Who volunteer to participate in the study will be included,
  • Pregnant women who are in the first stage of labor and have no obstetric complications.

You may not qualify if:

  • Individuals who are graduates of health vocational high schools,
  • Have disabilities in their eyes, hands, arms, or fingers,
  • Those who do not complete the training will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mardin Training and Research Hospital

Mardin, 47200, Turkey (Türkiye)

RECRUITING

Study Officials

  • Ülkin Gündüz Aruser, Ph.D

    Mardin Artuklu University

    PRINCIPAL INVESTIGATOR
  • Hacer Ünver Koca, Assoc. Prof.

    Inonu University

    STUDY DIRECTOR

Central Study Contacts

Ülkin Gündüz Aruser, Ph.D

CONTACT

Hacer Ünver Koca, Assoc. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants were blinded to group allocation, and the outcomes assessor was blinded to the intervention received by each participant to prevent assessment bias.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized, parallel-group controlled trial including an intervention group receiving mixed reality training and a control group receiving standard education.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 12, 2025

First Posted

November 20, 2025

Study Start

October 1, 2025

Primary Completion

December 1, 2025

Study Completion

February 1, 2026

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations