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OpenTrials
Completed

NCT Number: NCT07391085

Augmented Reality Training for Simulated Vaginal Birth

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, Chile

About this study

This multicenter randomized controlled educational study examined the effectiveness of an augmented reality (AR)-based pre-simulation training system for vaginal birth. The study was conducted at two universities in Chile and Colombia and included undergraduate medical students and midwifery students enrolled in obstetrics and gynecology or women's health courses as part of their regular curriculum.

Participants were randomly assigned to one of two groups. The control group received conventional pre-simulation preparation consisting of written materials and an instructional video covering the management of uncomplicated vaginal birth. The intervention group received the same preparation supplemented with a self-directed AR training module, which allowed learners to explore a simulated vaginal birth scenario, navigate procedural steps, and rehearse task sequencing prior to hands-on simulation.

All participants subsequently completed a standardized simulated vaginal birth using a high-fidelity childbirth simulator. Performance during the first simulation attempt was assessed by blinded evaluators using a previously published and validated Direct Observation of Procedural Skills (DOPS) checklist. The primary outcome was achievement of a predefined minimum competency threshold. Secondary outcomes included overall performance scores, completion of critical tasks, and learner satisfaction with the training experience.

The study was designed to isolate the effect of pre-simulation preparation on initial performance, before learning gains from repeated simulation and debriefing. The findings aim to inform the role of augmented reality as a scalable educational tool to support competency-based training in obstetric education.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Conventional training

Other

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

Augmented Reality Training

Other

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

Primary outcomes

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

    Time frame: Periprocedural (Day 1, during the first standardized 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.

Secondary outcomes

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

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

    Overall performance score obtained using the Direct Observation of Procedural Skills (DOPS) checklist (range 0-37), where higher scores indicate better performance, assessed during a standardized simulated vaginal birth.

  2. Number of participants completing all critical tasks during simulated vaginal birth

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

    Successful completion of all predefined critical motor and attitudinal tasks on the DOPS checklist during the first standardized simulated vaginal birth.

  3. Learner satisfaction with the training experience

    Time frame: Immediately after the simulation session

    Participant satisfaction assessed using a post-simulation satisfaction questionnaire on a Likert-type scale (range 1-5), where higher scores indicate greater satisfaction.

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Collaborators

  • Universidad de Los Andes, Bogota, Colombia

Registry information

Official study title

Augmented Reality Enhances Competency-Based Training in Simulated Vaginal Birth: A Multicenter Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.