Vaginal Birth EducationNCT07391085
Augmented Reality Training for Simulated Vaginal Birth
A study testing Conventional Training and Augmented Reality Training in people with Vaginal Birth Education, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaginal Birth Education
- What is being tested?
- Conventional Training and Augmented Reality Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 389 participants
- Where
- 1 siteChile
- Study dates
- 8 Mar 2023to 23 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Declined participation or withdrawal of consent.
- Incomplete participation in the simulation session.
- Incomplete or missing performance assessment data.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Pontificia Universidad Católica de Chile
Santiago, Santiago Metropolitan
About this study
Official title: Augmented Reality Enhances Competency-Based Training in Simulated Vaginal Birth: A Multicenter Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Vaginal Birth Education
- Being tested
- Conventional Training, Augmented Reality Training
- Keywords
- augmented reality, simulation-based education, vaginal birth, obstetric training, competency-based education, medical education, midwifery education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional TrainingOther
Text- and video-based preparation for simulated vaginal birth.
Augmented Reality TrainingOther
Augmented reality-based pre-simulation training module for vaginal birth.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Training | Active comparator | Participants received conventional pre-simulation preparation consisting of text-based materials and an instructional video covering uncomplicated vaginal birth. Receives: 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. Receives: Other: Augmented Reality Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Periprocedural (Day 1, during the first standardized simulated vaginal birth)
Number of participants completing all critical tasks during simulated vaginal birth
Successful completion of all predefined critical motor and attitudinal tasks on the DOPS checklist during the first standardized simulated vaginal birth.
Measured: Periprocedural (Day 1, during the first standardized simulated vaginal birth)
Learner satisfaction with the training experience
Participant satisfaction assessed using a post-simulation satisfaction questionnaire on a Likert-type scale (range 1-5), where higher scores indicate greater satisfaction.
Measured: Immediately after the simulation session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start8 Mar 2023
- Primary completion27 Nov 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaginal Birth EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Los Andes, Bogota, Colombia
- Responsible party
- Principal investigator, Jorge Carvajal Cabrera, Pontificia Universidad Catolica de Chile
- Investigators
- Jorge A Carvajal, PhD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07391085
- Sponsor's protocol ID
- IRB-UC-221212006-2023
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and confidentiality considerations. The dataset includes educational performance assessments of students, collected under informed consent for the purposes of this study only. Data are stored in accordance with institutional policies and applicable regulations, and no plans for public data sharing were approved by the ethics committees.
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Reality Enhances Competency-Based Training in Simulated Vaginal Birth: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07391085
- Acronym / sponsor ID
- IRB-UC-221212006-2023
- Conditions
- Vaginal Birth Education
- Keywords
- augmented reality, simulation-based education, vaginal birth, obstetric training, competency-based education, medical education, midwifery education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Universidad de Los Andes, Bogota, Colombia
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional Training | Active comparator | Other: Conventional TrainingParticipants received conventional pre-simulation preparation consisting of text-based materials and an instructional video covering uncomplicated vaginal birth. |
| Augmented Reality Training | Experimental | Other: Augmented Reality TrainingParticipants received conventional text- and video-based preparation supplemented with an augmented reality-based pre-simulation training module. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Declined participation or withdrawal of consent.
- Incomplete participation in the simulation session.
- Incomplete or missing performance assessment data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional TrainingText- and video-based preparation for simulated vaginal birth. | Other | Conventional Training |
| Augmented Reality TrainingAugmented reality-based pre-simulation training module for vaginal birth. | Other | Augmented Reality Training |
Primary outcome
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.
3 secondary outcomes
Mean Direct Observation of Procedural Skills (DOPS) score during simulated vaginal birth
Time frame: Periprocedural (Day 1, during the first standardized simulated vaginal birth)
Number of participants completing all critical tasks during simulated vaginal birth
Time frame: Periprocedural (Day 1, during the first standardized simulated vaginal birth)
Learner satisfaction with the training experience
Time frame: Immediately after the simulation session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- BackgroundValenzuela, 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
- Demonstration video of the augmented reality training module used in the study.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and confidentiality considerations. The dataset includes educational performance assessments of students, collected under informed consent for the purposes of this study only. Data are stored in accordance with institutional policies and applicable regulations, and no plans for public data sharing were approved by the ethics committees.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge A Carvajal, PhD principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Training and Augmented Reality Training in people with Vaginal Birth Education, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants achieving the minimum competency threshold during simulated vaginal birth (time frame: Periprocedural (Day 1, during the first standardized simulated vaginal birth)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07391085, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.