AzTrials
AzTrials

Clinical CompetenceARTESNCT07852078

Augmented Reality Training for Pelvic Exams and Pap Smears in Medical Students

A study testing Augmented Reality (AR)-Based Training and Conventional Text- and Video-Based Training in people with Clinical Competence, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This randomized controlled trial evaluated whether augmented reality (AR)-based pre-simulation training improves the acquisition of speculum examination and Papanicolaou (Pap) smear sampling competencies among undergraduate medical students, compared with conventional text- and video-based preparation. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Clinical Competence
What is being tested?
Augmented Reality (AR)-Based Training and Conventional Text- and Video-Based Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
1 siteChile
Study dates
1 Mar 2025to 1 Jun 2025
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Undergraduate medical student at the Pontificia Universidad Catolica de Chile
  • Enrolled in the Obstetrics and Gynecology course during the 2025 academic year
  • Willing to provide written informed consent

Who cannot join

  • Declined to provide informed consent

Trial locations and contacts

1 site in 1 country.

Chile1 site
  • Pontificia Universidad Católica de Chile

    Santiago, Santiago Metropolitan, 8320000

Other trials in Chile

About this study

Official title: Augmented Reality Enhances Competency-based Training in Speculum Examination and Papanicolaou Sampling: a Randomized Controlled Trial in Undergraduate Medical Students

This randomized controlled trial evaluated whether augmented reality (AR)-based pre-simulation training improves the acquisition of speculum examination and Papanicolaou (Pap) smear sampling competencies among undergraduate medical students, compared with conventional text- and video-based preparation. Participants were randomly assigned to receive AR-based training or conventional training before completing a standardized simulated speculum examination and Pap smear session, assessed using a validated Direct Observation of Procedural Skills (DOPS) checklist by a blinded evaluator. The primary outcome was achievement of a minimum competency threshold at the time of the simulation.

Read the detailed description

BACKGROUND

Contemporary training in gynecology requires a careful balance between foundational scientific knowledge, clinical practice, and the technical skills required in outpatient and inpatient settings. The knowledge and abilities that medical students must acquire during professional training correspond to what is termed clinical competencies. Students have traditionally been assessed on these competencies at the clinical workplace through direct supervision; however, the constraints of clinical practice and healthcare demand often prevent optimal conditions for ensuring that every student attains the minimum required competencies. Clinical simulation has therefore gained relevance across training centers, placing students in a context that replicates some aspect of clinical reality, although simulated settings require physical space and equipment (mannequins) of limited availability and high cost.

In routine gynecological training, competencies are acquired during the execution of clinical procedures. Simulation allows students to acquire basic manual skills and dexterity before facing clinical practice. Simulation is especially valuable in sensitive scenarios such as the gynecological examination, which involves an intrusion into the patient's privacy and makes it difficult to obtain consent for trainees to perform the examination. Published review evidence indicates that simulation of the pelvic examination (bimanual or speculum examination) provides a significant benefit over traditional teaching without simulation in terms of competence, confidence, and communication. Graduating medical students are expected to demonstrate proficiency in speculum examination and Papanicolaou (Pap) sampling; accordingly, simulation of this procedure is part of the current undergraduate curriculum at the participating institution.

Immersive technologies are reshaping health professions education. Virtual reality (VR) and augmented reality (AR) increasingly support clinical specialties, patient care, and health sciences education. VR/AR-based simulation is one of the recognized categories of simulation: interactive computer programs that reproduce situations in physiology, pharmacology, or clinical decision-making, with the principal aim of training and assessing knowledge and decision-making. Because AR and VR allow several students to train simultaneously, programs already exist for team-based training. VR and AR have been used for competency acquisition, emergency-response training, soft-skills training, and psychomotor training. Systematic review evidence on AR for teaching in the health sciences suggests that it is more effective for supporting skill development than knowledge acquisition; most AR systems concentrate on anatomy and surgery, although other practice areas are increasingly being explored.

Few studies have implemented AR/VR systems in obstetrics and gynecology. One study compared AR with traditional mannequin-based simulation for teaching intrapartum fetal monitoring analysis and found similar efficacy between the two modalities. A second study evaluated 360-degree video review before assisting in cesarean delivery and found no measurable benefit for students. Regarding the gynecological examination specifically, only one prior study has examined immersive technology-based training, and it measured exclusively student satisfaction rather than competency attainment; more than 90% of students considered the training useful for recalling task details, and the authors noted that further evaluation was needed to determine its effect on clinical competency. To the investigators' knowledge, no prior study has evaluated AR training for speculum examination and Pap smear sampling using a competency-based outcome.

To address this gap, the investigators designed and piloted a self-directed AR training system for speculum examination and Pap smear sampling, with an evaluation instrument developed and validated through a Delphi panel of gynecology experts. In a preliminary pre-post pilot study among six senior medical interns, AR training was associated with a significant improvement in Direct Observation of Procedural Skills (DOPS) scores (from 35.5 to 38.7; p = 0.017), a short mean training duration (16.9 minutes), and high learner satisfaction, but without a comparison group. Building on these preliminary findings, the present randomized controlled trial, with a blinded evaluator and a conventional-training control group, was conducted.

OBJECTIVES

The primary objective was to evaluate the effect of AR-based pre-simulation training on the acquisition of speculum examination and Pap sampling competencies among undergraduate medical students, compared with conventional text- and video-based preparation. Secondary objectives were to determine the number of simulation repetitions required to reach the minimum competency threshold and to assess student satisfaction with the AR platform.

STUDY DESIGN

Prospective, randomized, controlled trial with a blinded evaluator among undergraduate medical students at the Pontificia Universidad Catolica de Chile, Santiago, Chile. The study was approved by the Health Sciences Scientific Ethics Committee of the Pontificia Universidad Catolica de Chile (approval ID 241002001). The protocol was presented, in part, at the 2025 Latin American Congress on Resident Education.

AUGMENTED REALITY TRAINING SYSTEM

A speculum examination and Pap smear procedure was filmed in a real clinical consultation room, with prior institutional authorization, using a hybrid simulation model that combined a pelvic mannequin with a trained actress portraying the patient. Filming followed a single continuous take, without cuts or edits, using two synchronized cameras (a tripod-mounted 360-degree camera and a first-person head-mounted camera worn by the operator) to preserve procedural flow and realism. The footage was edited (Adobe Premiere Pro, GoPro Player) and developed into an interactive, self-directed AR module (Unity Editor) that allows students to alternate between first-person and external views, explore procedural steps at their own pace, and receive automatic feedback. The module incorporates an error-detection task, contextual infographics on equipment and procedural steps, and a formative quiz, and is hosted on a cloud-based platform (3DVista) accessible from any internet-connected device.

PARTICIPANTS AND RANDOMIZATION

Participants were undergraduate medical students enrolled in the Obstetrics and Gynecology course at the Pontificia Universidad Catolica de Chile during the 2025 academic year. All students entering the course were invited to participate; the eligibility criterion was willingness to provide informed consent, and students who declined were excluded. Consenting students were randomized to the study group (AR-based training) or the control group (conventional training) using a computer-generated randomization sequence with permuted blocks; allocation was concealed from the responsible investigator and from the teaching staff acting as evaluators. Participation, and the decision to participate or not, had no bearing on course grades or clinical teaching.

INTERVENTIONS

Control group: conventional training consisting of a written guide and an instructional video covering speculum examination and Pap smear sampling technique. After reviewing the material, students completed a hands-on simulation session on a high-fidelity pelvic simulator (Noelle) under blinded observation.

Study group: the same written guide and instructional video as the control group, plus self-directed training on the AR platform, which allows students to control their own pace and navigation and provides perspective switching, an error-detection task, contextual infographics, and a formative quiz. After completing the AR training, students underwent the same hands-on simulation session as the control group. The AR platform automatically logged each student's total time of use as an exploratory measure of engagement duration.

OUTCOME MEASURES

Primary outcome: achievement of the minimum competency threshold during a single standardized simulation of speculum examination and Pap smear sampling, assessed using a 20-item DOPS checklist previously developed and validated by the investigators. Minimum competency was defined a priori as achieving 75% or more of the maximum DOPS score. The observer was blinded to group allocation; students were identified only by a numeric code.

Secondary outcomes: mean DOPS score; achievement of a lower performance threshold (60% or more of items); number of simulation repetitions required to reach the minimum competency threshold; and student satisfaction with training, measured using a previously validated 7-item, 5-point Likert-scale perception survey adapted from a published instrument previously used among undergraduate students. Students in the AR group additionally answered supplementary items evaluating the AR platform's specific contribution to their preparation.

SAMPLE SIZE

Based on prior data suggesting 75% DOPS compliance on the first attempt in the control group, and an anticipated 10% absolute improvement (to 85%) in the AR group, a sample of 120 participants (60 per group) was calculated assuming 80% power, a one-sided alpha of 0.05, and a test of proportions. All undergraduate medical students enrolled in the 2025 cohort were invited to participate in order to achieve the target accrual.

STATISTICAL ANALYSIS

Descriptive and inferential analyses were performed using Python (v3.12) with the pandas and SciPy libraries. Continuous variables were compared between groups using the Mann-Whitney U test given non-normal distributions; categorical variables were compared using Fisher's exact test given low expected cell counts. A two-sided p < 0.05 was considered statistically significant.

ETHICAL CONSIDERATIONS

All participants provided written informed consent before enrollment. Participation was voluntary, and students were explicitly informed that declining to participate would have no effect on their grades, teaching, or study opportunities. Each student, whether or not enrolled in the study, was assigned a numeric identifier, and the blinded evaluator completed the DOPS checklist without knowledge of group allocation. Data from students who declined participation were excluded from the analysis dataset. The study posed no additional risk beyond routine simulation training. Students in the control group, as well as those who declined to participate, retained access to the AR platform after study completion. Data were de-identified, stored securely, accessible only to the research team, and will be retained for 10 years before destruction, in accordance with the approved protocol.

Being tested
Augmented Reality (AR)-Based Training, Conventional Text- and Video-Based Training
Keywords
Competency-based education, Papanicolaou, Speculum examination, Augmented reality, medical education, Simulation training;

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Augmented Reality (AR)-Based TrainingBehavioural

    Self-directed training on an interactive augmented reality platform simulating speculum examination and Papanicolaou sampling, completed in addition to standard text- and video-based preparation before a simulated speculum examination and Papanicolaou sampling session.

  • Conventional Text- and Video-Based TrainingBehavioural

    Standard preparation consisting of a written guide and an instructional video covering speculum examination and Papanicolaou sampling technique, completed before a simulated speculum examination and Papanicolaou sampling session.

Study groups in NCT07852078
Study groupRoleWhat they receive
AR (Study) GroupExperimentalAR-based pre-simulation training
Receives: Behavioral: Augmented Reality (AR)-Based Training
Control GroupExperimentalConventional text- and video-based training
Receives: Behavioral: Conventional Text- and Video-Based Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Participants Achieving the Minimum Competency Threshold on the Direct Observation of Procedural Skills (DOPS) Checklist

    Competency in speculum examination and Papanicolaou (Pap) smear sampling was assessed during a single standardized simulation on a high-fidelity pelvic simulator, using a 20-item Direct Observation of Procedural Skills (DOPS) checklist completed by an evaluator blinded to group allocation. Total DOPS scores range from 0 to 40, with higher scores indicating better procedural performance. The minimum competency threshold was defined a priori as a score of 75% or more of the maximum possible DOPS score. The outcome is reported as the number and proportion of participants in each group who achieved this threshold.

    Measured: Day 1 (single simulation session, immediately after completion of pre-simulation training).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2026
  2. Study start1 Mar 2025
  3. Primary completion1 Jun 2025
  4. Study completion1 Jun 2025

Resources

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 1:1 ratio to two parallel, concurrently enrolled groups. The study group received augmented reality (AR)-based training in addition to the standard text- and video-based preparation before completing a simulated speculum examination and Papanicolaou sampling session. The control group received the same standard text- and video-based preparation without the AR training component.
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07852078
Sponsor's protocol ID
241002001
Acronym
ARTES
Status last verified
Sep 2026
First submitted
20 Sep 2026
Last updated
1 Oct 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. The approved protocol and the informed consent specified that data would be accessible only to the research team. Given that participants belong to a single identifiable student cohort, sharing individual-level data could compromise participant confidentiality. Aggregate results will be made available through publication.

Publications

  • Arents V, de Groot PCM, Struben VMD, van Stralen KJ. Use of 360 degrees virtual reality video in medical obstetrical education: a quasi-experimental design. BMC Med Educ. 2021 Apr 10;21(1):202. doi: 10.1186/s12909-021-02628-5.

    PubMed 33836736
  • Plotzky C, Lindwedel U, Sorber M, Loessl B, Konig P, Kunze C, Kugler C, Meng M. Virtual reality simulations in nurse education: A systematic mapping review. Nurse Educ Today. 2021 Jun;101:104868. doi: 10.1016/j.nedt.2021.104868. Epub 2021 Mar 23.

    PubMed 33798987
  • Moawad GN, Elkhalil J, Klebanoff JS, Rahman S, Habib N, Alkatout I. Augmented Realities, Artificial Intelligence, and Machine Learning: Clinical Implications and How Technology Is Shaping the Future of Medicine. J Clin Med. 2020 Nov 25;9(12):3811. doi: 10.3390/jcm9123811.

    PubMed 33255705
  • Homer CS, Passant L, Kildea S, Pincombe J, Thorogood C, Leap N, Brodie PM. The development of national competency standards for the midwife in Australia. Midwifery. 2007 Dec;23(4):350-60. doi: 10.1016/j.midw.2006.03.008. Epub 2006 Nov 27.

    PubMed 17125891

Questions about this trial

What is this clinical trial studying?

A study testing Augmented Reality (AR)-Based Training and Conventional Text- and Video-Based Training in people with Clinical Competence, 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 3 inclusion and 1 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 1 Oct 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?

Proportion of Participants Achieving the Minimum Competency Threshold on the Direct Observation of Procedural Skills (DOPS) Checklist (time frame: Day 1 (single simulation session, immediately after completion of pre-simulation training).). 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 NCT07852078, which also lists 4 linked publications.

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 1 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in