Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-02-23 @ 1:42 PM
Study NCT ID:
NCT06552195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-13
First Post:
2024-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Augmented Reality in Learning Anatomy: The TEACHANATOMY Randomized Cross-over Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'outcomes (knowledge test, adverse health symptoms and user experience) will be assessed blindly'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2024-08-09', 'studyFirstSubmitQcDate': '2024-08-09', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'knowledge test', 'timeFrame': 'immediately after the study session, day 1, and after three months', 'description': 'The primary outcome will consist of the score in the final theoretical and practical tests. The theoretical test consists of single and multiple-choice questions in which participants will be required to recognize and name the different anatomical structures of the hips or shoulder and their function. In the practical part, participants will be required to mark specific anatomical structures in a 3D-printed anatomical skull model. The duration of the test will be of approximately 30 minutes.'}], 'secondaryOutcomes': [{'measure': 'adverse health symptoms', 'timeFrame': 'Immediately after the knowledge test, Day 1', 'description': 'Secondary outcomes will include adverse health symptoms, evaluated with a questionnaire to assess presence and severity of general symptoms (General discomfort, Fatigue, Headache, Dizziness, Nausea, Concentration problems, Disorientation, Neck stiffness/neck pain, No symptoms) and eye-related symptoms (Blurred vision, Difficulty focusing, Double-vision, Dry eyes No symptoms). Presence and severity of symptoms will be rated on a Likert scale from 1 (almost imperceptible) to 10 (extreme).'}, {'measure': 'User experience', 'timeFrame': 'Immediately after the Adverse health symptoms, Day 1', 'description': 'User experience will be assessed using an adapted NASA Task Load Index (5 questions, range, 1-10, with lower scores indicating lower cognitive workload) plus additional 10-point Likert scale and open-ended questions in which participants will be asked to rank their comfort with the material and hardware and the teaching effectiveness of the software or of the traditional learning methods to learn anatomy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anatomy teaching', 'Augmented reality', 'Magic leap'], 'conditions': ['Augmented Reality', 'Anatomy Education']}, 'referencesModule': {'references': [{'pmid': '33945136', 'type': 'BACKGROUND', 'citation': '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': '34315955', 'type': 'BACKGROUND', 'citation': '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': '31978568', 'type': 'BACKGROUND', 'citation': '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': '36569366', 'type': 'BACKGROUND', 'citation': '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': '36706637', 'type': 'BACKGROUND', 'citation': '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': '34800073', 'type': 'BACKGROUND', 'citation': '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': '33378557', 'type': 'BACKGROUND', 'citation': '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': '36662102', 'type': 'BACKGROUND', 'citation': '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': '34457656', 'type': 'BACKGROUND', 'citation': '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': '32488637', 'type': 'BACKGROUND', 'citation': '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': '28419750', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.magicleap.com/en-gb', 'label': 'Magic Leap headsets devise'}]}, 'descriptionModule': {'briefSummary': 'Cadaver use in anatomy education is undergoing several limitations in many universities, due to high costs, time constraints and supply difficulties. As alternatives to cadaver dissections, new teaching methods based on visual technologies, such as augmented reality (AR), are being implemented worldwide.\n\nAugmented reality (AR), based on virtual interactive 3-dimensional elements (holograms) overlaid in the real-world, represents a promising alternative to explore the human body. In this study, we will test the efficacy of AR as an alternative teaching method in anatomy education by comparing traditional learning methods based on 2-dimensional (2D) images, videos, and online learning programs with the novel AR learning module The primary endpoint will consist of the score in the final theoretical and practical knowledge tests, assessed at two timepoints: immediately after the study session and after 3 months.\n\nSecondary endpoints will include adverse health symptoms and user experience, assessed immediately after the study session.', 'detailedDescription': 'Cadaver use in anatomy education is undergoing several limitations in many universities, due to high costs, time constraints and supply difficulties. As alternatives to cadaver dissections, new teaching methods based on visual technologies, such as augmented reality (AR), are being implemented worldwide.\n\nAugmented reality (AR), based on virtual interactive 3-dimensional elements (holograms) overlaid in the real-world, represents a promising alternative to explore the human body. In this study, we will test the efficacy of AR as an alternative teaching method in anatomy education. Our hypothesis is that learning with AR is more efficient than traditional learning methods.\n\nPreparation: We will prepare 2 fresh-frozen cadaveric specimens to allow visualization of anatomical structure of the shoulder and hips. The cadavers will be obtained from a human body donated for university teaching activities. Using a digital single-lens reflex camera, we will acquire several images. These images will be then converted into a 3D model by the ROCS team at Balgrist University Hospital and optimized for use with the Magic Leap AR headset.\n\nProcedure: Participants (approx. 300) will be randomly assigned to the AR or the traditional learning (TL) group. Each participant will learn one anatomy module with traditional learning methods, which will include books, access to websites, 3D videos, and online learning programs, and one module with the AR-based learning program. The two modules will be administered approximately 3 weeks apart.\n\nGroup A: Shoulder anatomy with traditional learning methods and hips anatomy with AR based 3D program.\n\nGroup B: Shoulder anatomy with AR based 3D program and hips anatomy with traditional learning methods.\n\nThe primary endpoint will consist of the score in the final theoretical and practical anatomy tests, assessed at two timepoints: immediately after the study session and after 3 months.\n\nSecondary endpoints include adverse health symptoms, assessed with a Likert scale survey, and user experience, evaluated using an adapted NASA Task Load Index scale plus additional questions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical students attending the 1st or 2nd year of undergraduate medical education\n* Must not have prior anatomical education\n\nExclusion Criteria:\n\n* Epilepsy\n* Binocular vision disorder such as strabismus\n* Current head and/or neck injuries\n* Inflammation of the scalp and/or eye\n* Amputations or partial amputations of the hands'}, 'identificationModule': {'nctId': 'NCT06552195', 'briefTitle': 'Augmented Reality in Learning Anatomy: The TEACHANATOMY Randomized Cross-over Trial', 'organization': {'class': 'OTHER', 'fullName': 'Balgrist University Hospital'}, 'officialTitle': 'Hologram-Based Augmented Reality in Learning Anatomy: The TEACHANATOMY Randomized Cross-over Trial', 'orgStudyIdInfo': {'id': 'TEACHANATOMY 2.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Shoulder anatomy with augmented reality (AR) , hips anatomy with traditional learning (TL)', 'description': 'Participants first learn the shoulder anatomy with AR. After a washout period of three weeks, they will learn the hips anatomy with traditional Learning (TL) methods', 'interventionNames': ['Other: learning with augmented reality', 'Other: learning with traditional methods']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional learning (TL) group.', 'description': 'Participants first learn the shoulder anatomy with Traditional learning methods. After a washout period of three weeks, they will learn the hips anatomy with augmented reality (AR)', 'interventionNames': ['Other: learning with augmented reality', 'Other: learning with traditional methods']}], 'interventions': [{'name': 'learning with augmented reality', 'type': 'OTHER', 'description': '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.\n\n* 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.\n* Assessment test: Participants will be assessed with a 30 minutes knowledge assessment test at the end of the study and after three months.\n* Final questionnaire: At the end of the study session participants will be given a questionnaire to assess adverse health symptoms and user experience.', 'armGroupLabels': ['Shoulder anatomy with augmented reality (AR) , hips anatomy with traditional learning (TL)', 'Traditional learning (TL) group.']}, {'name': 'learning with traditional methods', 'type': 'OTHER', 'description': '* Study presentation: participants will be given a 10-minute general introduction on the study followed by a presentation to introduce the study session.\n* 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.\n* Assessment test: Participants will be assessed with a 30 minutes knowledge assessment test at the end of the study and after three months.\n* Final questionnaire: At the end of the study session participants will be given a questionnaire to assess adverse health symptoms and user experience', 'armGroupLabels': ['Shoulder anatomy with augmented reality (AR) , hips anatomy with traditional learning (TL)', 'Traditional learning (TL) group.']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Lukas Zingg, MD', 'role': 'CONTACT', 'email': 'Lukas.zingg@balgrist.ch', 'phone': '0796644805', 'phoneExt': '+41'}, {'name': 'Philipp Fürnstahl, Prof.', 'role': 'CONTACT', 'email': 'philipp.fuernstahl@balgrist.ch', 'phone': '044 510 73 60', 'phoneExt': '+41'}], 'overallOfficials': [{'name': 'Lukas Zingg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Balgrust University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balgrist University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'ETH Zurich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}