Augmented Reality Training for Simulated Vaginal Birth

NCT07391085 | Completed

• 1 other identifier: IRB-UC-221212006-2023
• Study Type: interventional
• Target: 389
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated whether an augmented reality (AR)-based training system improves preparation for simulated vaginal birth compared with traditional text- and video-based learning. Vaginal birth is a complex clinical skill that requires integration of technical actions, situational awareness, and professional behaviors, and opportunities for hands-on training may be limited during undergraduate education. Undergraduate medical students and midwifery students from two universities in Chile and Colombia were randomly assigned to either conventional preparation (text and instructional video) or the same preparation supplemented with an AR training module. The AR system allowed students to explore a simulated vaginal birth scenario in a self-directed manner before participating in hands-on simulation. All students then completed a standardized simulated vaginal birth using a high-fidelity simulator as part of their regular curriculum. Performance during the first simulation was assessed by blinded evaluators using a validated Direct Observation of Procedural Skills (DOPS) checklist. The primary outcome was achievement of a predefined minimum competency threshold, with secondary outcomes including overall performance scores, completion of critical tasks, and learner satisfaction. The goal of this study was to determine whether AR-based pre-simulation training enhances early performance in simulated vaginal birth and could serve as a scalable educational tool to support competency-based training in obstetrics.

Conditions

Vaginal Birth Education

Keywords

augmented reality; simulation-based education; vaginal birth; obstetric training; competency-based education; medical education; midwifery education

Outcome Measures

Primary Outcomes (1)

• Number of participants achieving the minimum competency threshold during simulated vaginal birth

  Achievement of a predefined minimum competency threshold assessed using a validated Direct Observation of Procedural Skills (DOPS) checklist during a standardized simulated vaginal birth. Competency was defined as a DOPS score ≥35 with successful completion of all critical items.

  Periprocedural (Day 1, during the first standardized simulated vaginal birth)

Secondary Outcomes (3)

• Mean Direct Observation of Procedural Skills (DOPS) score during simulated vaginal birth

  Periprocedural (Day 1, during the first standardized simulated vaginal birth)

• Number of participants completing all critical tasks during simulated vaginal birth

  Periprocedural (Day 1, during the first standardized simulated vaginal birth)

• Learner satisfaction with the training experience

  Immediately after the simulation session

Study Arms (2)

Conventional Training

ACTIVE COMPARATOR

Participants received conventional pre-simulation preparation consisting of text-based materials and an instructional video covering uncomplicated vaginal birth.

Other: Conventional Training

Augmented Reality Training

EXPERIMENTAL

Participants received conventional text- and video-based preparation supplemented with an augmented reality-based pre-simulation training module.

Other: Augmented Reality Training

Interventions

Conventional Training OTHER

Text- and video-based preparation for simulated vaginal birth.

Conventional Training

Augmented Reality Training OTHER

Augmented reality-based pre-simulation training module for vaginal birth.

Augmented Reality Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergraduate medical students or midwifery students enrolled in obstetrics and gynecology or women's health courses at the participating universities.
• Enrollment in the corresponding academic cohort during the study period.
• Age 18 years or older.
• Willingness to participate and provision of informed consent.

You may not qualify if:

• Declined participation or withdrawal of consent.
• Incomplete participation in the simulation session.
• Incomplete or missing performance assessment data.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Universidad de Los Andes, Bogota, Colombia: collaborator

Study Sites (1)

Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (1)

• Valenzuela, M. T., & Carvajal Cabrera, J. A. (2022). Eficiencia del entrenamiento simulado del parto vaginal en estudiantes de enfermería/obstetricia: The efficiency of simulated vaginal birth training in nursing/midwifery students. ARS MEDICA Revista De Ciencias Médicas, 47(4), 25-31. https://doi.org/10.11565/arsmed.v47i4.1911

  BACKGROUND

Related Links

• Demonstration video of the augmented reality training module used in the study.

Study Officials

• Jorge A Carvajal, PhD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to group allocation. Students were identified only by numeric codes during the simulation, and evaluators completed performance assessments without knowledge of whether participants had received augmented reality training.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Obstetrics and Gynecology

Model Details: Participants were randomly assigned in a parallel design to either a control group receiving conventional text- and video-based preparation or an intervention group receiving the same preparation supplemented with augmented reality-based training. Each participant was exposed to only one study arm.

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 5, 2026
• Study Start: March 8, 2023
• Primary Completion: November 27, 2024
• Study Completion: December 23, 2024
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)