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Imparting of Practical Skills by Digital Methods

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ClinicalTrials.gov Identifier: NCT04842357
Recruitment Status : Completed
First Posted : April 13, 2021
Last Update Posted : August 27, 2021
Sponsor:
Information provided by (Responsible Party):
Thomas Ott, Johannes Gutenberg University Mainz

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Clinical Skills Intra-osseous Sutures Education Other: standardised video concerning clinical skill Not Applicable

Detailed Description:
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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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).
Masking: None (Open Label)
Masking Description: The participant cannot be masked because they realise if they are in group A or B
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : May 25, 2021
Actual Primary Completion Date : June 11, 2021
Actual Study Completion Date : July 30, 2021
Arms and Interventions
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Arm Intervention/treatment
video - then self-study
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).
 Other: standardised video concerning clinical skill
watching a video concerning clinical skills.
self-study, then video
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).
 Other: standardised video concerning clinical skill
watching a video concerning clinical skills.


Outcome Measures
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Primary Outcome Measures :
  1. Donati suture: "Task-Specific Score" [ Time Frame: 1 week ]
    Score to quantify the particular skill: Minimum / worst performance 8, Max / best performance: 40

  2. Intraosseous venous access: "Intraosseous Access Performance Assessment Scale" [ Time Frame: 1 week ]
    Score to quantify the particular skill: Minimum / worst performance 0, Max / best performance: 17


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • medical student in the last year of the curriculum

Exclusion Criteria:

  • no medical student in the last year of the curriculum
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04842357


Locations
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Germany
University Hospital Centre Mainz
Mainz, RLP, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
Investigators
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Study Director: Sven-Oliver O. Dietz, M.D., Ph.D. Trauma Surgery / Zentrum für Orthopädie und Unfallchirurgie, Langebeckstr. 1, 55131 Mainz, Germany
Study Director: Thomas Ott, M.D. Department of Anaesthesiology / Klinik für Anästhesiologie, Langenbeckstr. 1, 55131 Mainz, Germany
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Thomas Ott, Thomas Ott, M.D., DESA, Scientific consultant of the simulation center, Department of Anesthesiology, University Hospital Center, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT04842357    
Other Study ID Numbers: UM-Nr. 21-00483
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will decide after ethical review board approval.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: expected 2022
Access Criteria: via journal access policies

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thomas Ott, Johannes Gutenberg University Mainz:
clinical skills
intraosseous access
Donati suture
 imparting skills
education
undergraduate education