Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-30 @ 5:37 AM
Study NCT ID:
NCT04842357
Status:
COMPLETED
Last Update Posted:
2021-08-27
First Post:
2021-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imparting of Practical Skills by Digital Methods
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The participant cannot be masked because they realise if they are in group A or B'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The investigators will recruit last year medical students and randomise them into two groups: Group A and Group B. Both groups will be video recorded during the performance of the two skills on simulators (i.s. Donati suture and intraosseous venous access) (timepoint: T0). Then group A will watch a standardised video about the skills, and group B will do self-study. Then, both groups will be again video recorded during the performance of the two skills on simulators (timepoint: T1). After 1 week group B will watch the same standardised video about the skills, and group A will do self-study. Then both groups will be again video recorded during the performance of the two skills on simulators (timepoint: T2).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-23', 'studyFirstSubmitDate': '2021-04-06', 'studyFirstSubmitQcDate': '2021-04-09', 'lastUpdatePostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Donati suture: "Task-Specific Score"', 'timeFrame': '1 week', 'description': 'Score to quantify the particular skill: Minimum / worst performance 8, Max / best performance: 40'}, {'measure': 'Intraosseous venous access: "Intraosseous Access Performance Assessment Scale"', 'timeFrame': '1 week', 'description': 'Score to quantify the particular skill: Minimum / worst performance 0, Max / best performance: 17'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['clinical skills', 'intraosseous access', 'Donati suture', 'imparting skills', 'education', 'undergraduate education'], 'conditions': ['Clinical Skills', 'Intra-osseous', 'Sutures', 'Education']}, 'referencesModule': {'references': [{'pmid': '19643511', 'type': 'BACKGROUND', 'citation': 'Levitan RM, Bortle CD, Snyder TA, Nitsch DA, Pisaturo JT, Butler KH. Use of a battery-operated needle driver for intraosseous access by novice users: skill acquisition with cadavers. Ann Emerg Med. 2009 Nov;54(5):692-4. doi: 10.1016/j.annemergmed.2009.06.012. Epub 2009 Jul 29.'}, {'pmid': '17564692', 'type': 'BACKGROUND', 'citation': 'Lee JC, Boyd R, Stuart P. Randomized controlled trial of an instructional DVD for clinical skills teaching. Emerg Med Australas. 2007 Jun;19(3):241-5. doi: 10.1111/j.1742-6723.2007.00976.x.'}, {'pmid': '19215895', 'type': 'RESULT', 'citation': 'Shippey S, Handa VL, Chen TL, Chou B, Bowen CW. Validation of an instrument for evaluation of subcuticular suturing using a plastic tissue model. J Surg Educ. 2009 Jan-Feb;66(1):31-4. doi: 10.1016/j.jsurg.2008.09.001.'}, {'pmid': '21821220', 'type': 'RESULT', 'citation': 'Shippey SH, Chen TL, Chou B, Knoepp LR, Bowen CW, Handa VL. Teaching subcuticular suturing to medical students: video versus expert instructor feedback. J Surg Educ. 2011 Sep-Oct;68(5):397-402. doi: 10.1016/j.jsurg.2011.04.006. Epub 2011 Jun 25.'}, {'pmid': '22511182', 'type': 'RESULT', 'citation': 'Oriot D, Darrieux E, Boureau-Voultoury A, Ragot S, Scepi M. Validation of a performance assessment scale for simulated intraosseous access. Simul Healthc. 2012 Jun;7(3):171-5. doi: 10.1097/SIH.0b013e31824a5c20.'}, {'pmid': '38956562', 'type': 'DERIVED', 'citation': 'Ott T, Demare T, Mohrke J, Silber S, Schwab J, Reuter L, Westhphal R, Schmidtmann I, Dietz SO, Pirlich N, Ziebart A, Engelhard K. Does an instructional video as a stand-alone tool promote the acquisition of practical clinical skills? A randomised simulation research trial of skills acquisition and short-term retention. BMC Med Educ. 2024 Jul 2;24(1):714. doi: 10.1186/s12909-024-05714-6.'}]}, 'descriptionModule': {'briefSummary': 'Due to the corona pandemia and the consecutive reduction of teaching students face to face the imparting of medical skills is limited. Video sequences may be an adequate alternative to educate selected practical skills. So, the investigators intend to explore this aspect as a first concerning two basic medical skills: Donati suture and intraosseous venous access.', 'detailedDescription': 'The investigators will recruit last year medical students and randomise them into two groups: Group A and Group B. Both groups will be video recorded during the performance of the two skills on simulators (i.s. Donati suture and intraosseous venous access) (timepoint: T0). Then group A will watch a standardised video about the skills, and group B will do self-study. Then, both groups will be again video recorded during the performance of the two skills on simulators (timepoint: T1). After 1 week group B will watch the same standardised video about the skills, and group A will do self-study. Then both groups will be again video recorded during the performance of the two skills on simulators (timepoint: T2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* medical student in the last year of the curriculum\n\nExclusion Criteria:\n\n* no medical student in the last year of the curriculum'}, 'identificationModule': {'nctId': 'NCT04842357', 'briefTitle': 'Imparting of Practical Skills by Digital Methods', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'Imparting of Practical Skills by Digital Methods - Effectivity of Digital Education Under Conditions of the Pandemia Concerning the Application of Donati Suture and the Application of an Intraosseous Venous Access', 'orgStudyIdInfo': {'id': 'UM-Nr. 21-00483'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'video - then self-study', 'description': 'Group A will be video recorded during the performance of the two skills on simulators (i.e. Donati suture and intraosseous venous access) (timepoint: T0). Then group A will watch a standardised video about the skills, then will be again video recorded during the performance of the two skills on simulators (timepoint: T1). After 1 to 2 weeks group A will do self-study, then will be again video recorded during the performance of the two skills on simulators (timepoint: T2).', 'interventionNames': ['Other: standardised video concerning clinical skill']}, {'type': 'OTHER', 'label': 'self-study, then video', 'description': 'Group B will be video recorded during the performance of the two skills on simulators (i.e. Donati suture and intraosseous venous access) (timepoint: T0). Then group B will do self-study, then will be again video recorded during the performance of the two skills on simulators (timepoint: T1). After 1 to 2 weeks group B will watch the standardised video about the skills, then will be again video recorded during the performance of the two skills on simulators (timepoint: T2).', 'interventionNames': ['Other: standardised video concerning clinical skill']}], 'interventions': [{'name': 'standardised video concerning clinical skill', 'type': 'OTHER', 'description': 'watching a video concerning clinical skills.', 'armGroupLabels': ['self-study, then video', 'video - then self-study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'state': 'RLP', 'country': 'Germany', 'facility': 'University Hospital Centre Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'overallOfficials': [{'name': 'Sven-Oliver O. Dietz, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Trauma Surgery / Zentrum für Orthopädie und Unfallchirurgie, Langebeckstr. 1, 55131 Mainz, Germany'}, {'name': 'Thomas Ott, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anaesthesiology / Klinik für Anästhesiologie, Langenbeckstr. 1, 55131 Mainz, Germany'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'expected 2022', 'ipdSharing': 'YES', 'description': 'We will decide after ethical review board approval.', 'accessCriteria': 'via journal access policies'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Thomas Ott, M.D., DESA, Scientific consultant of the simulation center, Department of Anesthesiology, University Hospital Center', 'investigatorFullName': 'Thomas Ott', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}