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

NCT07852078 | Completed

• 1 other identifier: 241002001
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Clinical Competence

Keywords

Competency-based education; Papanicolaou; Speculum examination; Augmented reality; medical education; Simulation training;

Outcome Measures

Primary Outcomes (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.

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

Study Arms (2)

AR (Study) Group

EXPERIMENTAL

AR-based pre-simulation training

Behavioral: Augmented Reality (AR)-Based Training

Control Group

EXPERIMENTAL

Conventional text- and video-based training

Behavioral: Conventional Text- and Video-Based Training

Interventions

Conventional Text- and Video-Based Training BEHAVIORAL

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.

Control Group

Augmented Reality (AR)-Based Training BEHAVIORAL

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.

AR (Study) Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• \- Declined to provide informed consent

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Pontificia Universidad Católica de Chile

Santiago, Santiago Metropolitan, 8320000, Chile

Location

Related Publications (4)

• 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.

  PMID: 33836736 BACKGROUND

• 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.

  PMID: 33798987 BACKGROUND

• 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.

  PMID: 33255705 BACKGROUND

• 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.

  PMID: 17125891 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor was blinded to group allocation. Participants were identified only by a numeric code during the simulation assessment, and the assessor had no access to randomization records. Allocation was concealed from the responsible investigator and from the teaching staff acting as evaluators, using a computer-generated randomization sequence with permuted blocks.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 20, 2026
• First Posted: October 1, 2026
• Study Start: March 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)