Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-29 @ 4:25 PM
Study NCT ID:
NCT05066204
Status:
COMPLETED
Last Update Posted:
2022-04-07
First Post:
2021-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Different Teaching- and Learningmethods
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Investigator are blinded/masked against the study arm of the particular assessed participant.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two unbound samples running through a different sequence of teching-/learningmethods'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2021-09-23', 'studyFirstSubmitQcDate': '2021-09-23', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sum of score', 'timeFrame': '1 Day', 'description': "sum of the score used to evaluate the particpants' performance by video records"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complication of Infusion', 'Education, Medical']}, 'referencesModule': {'references': [{'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. The investigators explored this aspect in spring 2021 concerning the humeral intraosseous access. This study was registered under ClinicalTrials: NCT04842357. Data is still under statistical analysis and not published yet. As a secondary endpoint we found participant having done self-study first and watched a teaching-video one week later performed better than participant in the vice versa sequence. This may have important curricular implications. So, we launch the present study to investigate, if the sequence: Self-Study, then Teaching-Video is more efficient than vice versa.', 'detailedDescription': 'The investigators will recruit last year medical students and randomise them into two groups: Group A and Group B. Group A will watch a standardised video about the skill, then directly do self-study. Group B will do self-study and then directly watch a standardised video. Right after this, both groups will be video recorded during the performance of the skill: humeral intraosseous access on a simulator. The performance will be quantified by a scale by two investigators'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* voluteer medical students in their last year of medical school (i.e. after 2nd state board in Germany)\n* writen informed consert\n\nExclusion Criteria:\n\n* denial of participation'}, 'identificationModule': {'nctId': 'NCT05066204', 'briefTitle': 'Evaluation of Different Teaching- and Learningmethods', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'Evaluation of Different Teaching- and Learningmethods Concerning the Humeral Intraosseal Access in Inexperienced Providers', 'orgStudyIdInfo': {'id': '2021-16112 EK RLP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Sequence: self-study, then teaching video', 'description': 'Participants first do self-study, then right afterwards watch a teaching video, then become tested on a simulator and are videorecorded for evaluation', 'interventionNames': ['Other: Sequence of teaching-/learningmethod']}, {'type': 'OTHER', 'label': 'Sequence: teaching video, then self study', 'description': 'Participants first watch a teaching video, then do self-study, then become tested on a simulator and are videorecorded for evaluation', 'interventionNames': ['Other: Sequence of teaching-/learningmethod']}], 'interventions': [{'name': 'Sequence of teaching-/learningmethod', 'type': 'OTHER', 'description': 'see: arm/group descriptions', 'armGroupLabels': ['Sequence: self-study, then teaching video', 'Sequence: teaching 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}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, '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'}}}}