NCT05985746

Brief Summary

The goal of this clinical trial is to assess the efficacy of augmented reality (AR) in anatomy teaching. The main question to answer is: Is 3-Dimensional AR technology more effective than traditional learning methods in anatomy education? In this clinical trial undergraduate medical students with no prior anatomy education will be recruited. Participants in the AR group will learn the anatomy of the cranial nerves with an AR application using Microsoft HoloLens 2, whereas participants in the control group will learn with traditional learning methods (textbooks, atlases, videos, and online learning programs).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

July 17, 2023

Last Update Submit

August 9, 2023

Conditions

Keywords

Anatomy teachingAugmented realityMicrosoft HoloLensCranial nerves

Outcome Measures

Primary Outcomes (1)

  • Knowledge acquisition

    The primary outcome will consist of the score in the final theoretical and practical tests. The theoretical test consist of 23 single and multiple-choice questions in which participants will be required to recognize and name the 12 cranial nerves, differentiate their main functions and the typology (sensory, motor, mixed), explain the relationships between their structure and function, and recognize lesions using case studies. In the practical part, participants will be required to mark specific nerves in a 3D-printed anatomical skull model. The duration of the test will be of 30 minutes.

    Immediately after the study session, Day 1

Secondary Outcomes (2)

  • Adverse Health Symptoms

    Immediately after the knowledge acquisition test, Day 1.

  • User experience

    Immediately after the knowledge acquisition test, Day 1.

Study Arms (2)

Augmented Reality (AR) group.

EXPERIMENTAL

\- The experimental group will consist of approximately 20 undergraduate medical students. Participants will use the TEACHANATOMY learning application with the HoloLens 2.

Other: Augmented reality group

Traditional learning (TL) group.

ACTIVE COMPARATOR

\- The control group will consist of approximately 20 undergraduate medical students. Participants will use traditional learning methods with textbooks, atlases, videos, and online learning programs,

Other: Traditional learning group

Interventions

* Study presentation: participants will be given a 10-minute general introduction on the study followed by a 20 minutes tutorial to introduce the HoloLens 2 and the TEACHANATOMY learning platform. * Study session: The study session consists of three learning blocks of approximately 20 minutes each, plus a repetition block to assess the acquired knowledge. During the study session participants will be given no time constraints and free breaks. * Assessment test: Participants will be assessed with a 30 minutes knowledge assessment test. * Final questionnaire: At the end participants will be given a questionnaire to assess adverse health symptoms and user experience.

Augmented Reality (AR) group.

* Study presentation: participants will be given a 10-minute general introduction on the study followed by a presentation to introduce the study session. * Study session: The study session consists of the learning resources most used by students: specific sections from four different neuroanatomy books, access to two websites, two 3D videos, and two online learning programs. During the study session participants will be given no time constraints and free breaks. * Assessment test: Participants will be assessed with a 30 minutes knowledge assessment test. * Final questionnaire: At the end participants will be given a questionnaire to assess adverse health symptoms and user experience.

Traditional learning (TL) group.

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Medical students attending the 1st or 2nd year of undergraduate medical education
  • Must not have prior neuroanatomical education

You may not qualify if:

  • Epilepsy
  • Binocular vision disorder such as strabismus
  • Current head and/or neck injuries
  • Inflammation of the scalp and/or eye
  • Amputations or partial amputations of the hands

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist University Hospital

Zurich, Z, 8008, Switzerland

Location

Related Publications (12)

  • Moro C, Stromberga Z, Raikos A, Stirling A. The effectiveness of virtual and augmented reality in health sciences and medical anatomy. Anat Sci Educ. 2017 Nov;10(6):549-559. doi: 10.1002/ase.1696. Epub 2017 Apr 17.

    PMID: 28419750BACKGROUND
  • Bolek KA, De Jong G, Henssen D. The effectiveness of the use of augmented reality in anatomy education: a systematic review and meta-analysis. Sci Rep. 2021 Jul 27;11(1):15292. doi: 10.1038/s41598-021-94721-4.

    PMID: 34315955BACKGROUND
  • Chytas D, Johnson EO, Piagkou M, Mazarakis A, Babis GC, Chronopoulos E, Nikolaou VS, Lazaridis N, Natsis K. The role of augmented reality in Anatomical education: An overview. Ann Anat. 2020 May;229:151463. doi: 10.1016/j.aanat.2020.151463. Epub 2020 Jan 21.

    PMID: 31978568BACKGROUND
  • Curran VR, Xu X, Aydin MY, Meruvia-Pastor O. Use of Extended Reality in Medical Education: An Integrative Review. Med Sci Educ. 2022 Dec 19;33(1):275-286. doi: 10.1007/s40670-022-01698-4. eCollection 2023 Feb.

    PMID: 36569366BACKGROUND
  • Gsaxner C, Li J, Pepe A, Jin Y, Kleesiek J, Schmalstieg D, Egger J. The HoloLens in medicine: A systematic review and taxonomy. Med Image Anal. 2023 Apr;85:102757. doi: 10.1016/j.media.2023.102757. Epub 2023 Jan 21.

    PMID: 36706637BACKGROUND
  • McBain KA, Habib R, Laggis G, Quaiattini A, M Ventura N, Noel GPJC. Scoping review: The use of augmented reality in clinical anatomical education and its assessment tools. Anat Sci Educ. 2022 Jul;15(4):765-796. doi: 10.1002/ase.2155. Epub 2022 Jan 19.

    PMID: 34800073BACKGROUND
  • Moro C, Birt J, Stromberga Z, Phelps C, Clark J, Glasziou P, Scott AM. Virtual and Augmented Reality Enhancements to Medical and Science Student Physiology and Anatomy Test Performance: A Systematic Review and Meta-Analysis. Anat Sci Educ. 2021 May;14(3):368-376. doi: 10.1002/ase.2049. Epub 2021 Feb 26.

    PMID: 33378557BACKGROUND
  • Navab N, Martin-Gomez A, Seibold M, Sommersperger M, Song T, Winkler A, Yu K, Eck U. Medical Augmented Reality: Definition, Principle Components, Domain Modeling, and Design-Development-Validation Process. J Imaging. 2022 Dec 23;9(1):4. doi: 10.3390/jimaging9010004.

    PMID: 36662102BACKGROUND
  • Stojanovska M, Tingle G, Tan L, Ulrey L, Simonson-Shick S, Mlakar J, Eastman H, Gotschall R, Boscia A, Enterline R, Henninger E, Herrmann KA, Simpson SW, Griswold MA, Wish-Baratz S. Mixed Reality Anatomy Using Microsoft HoloLens and Cadaveric Dissection: A Comparative Effectiveness Study. Med Sci Educ. 2019 Nov 15;30(1):173-178. doi: 10.1007/s40670-019-00834-x. eCollection 2020 Mar.

    PMID: 34457656BACKGROUND
  • Stromberga Z, Phelps C, Smith J, Moro C. Teaching with Disruptive Technology: The Use of Augmented, Virtual, and Mixed Reality (HoloLens) for Disease Education. Adv Exp Med Biol. 2021;1317:147-162. doi: 10.1007/978-3-030-61125-5_8.

    PMID: 33945136BACKGROUND
  • Uruthiralingam U, Rea PM. Augmented and Virtual Reality in Anatomical Education - A Systematic Review. Adv Exp Med Biol. 2020;1235:89-101. doi: 10.1007/978-3-030-37639-0_5.

    PMID: 32488637BACKGROUND
  • Ghosh SK. Cadaveric dissection as an educational tool for anatomical sciences in the 21st century. Anat Sci Educ. 2017 Jun;10(3):286-299. doi: 10.1002/ase.1649. Epub 2016 Aug 30.

    PMID: 27574911BACKGROUND

Related Links

Study Officials

  • Lukas Zingg, Cand. Med.

    Balgrust University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Medicine

Study Record Dates

First Submitted

July 17, 2023

First Posted

August 14, 2023

Study Start

August 21, 2022

Primary Completion

October 24, 2022

Study Completion

October 24, 2022

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations