Clinical SkillsNCT04842357
Imparting of Practical Skills by Digital Methods
A study testing standardised video concerning clinical skill in people with Clinical Skills and Intra-osseous, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Skills, Intra-osseous, Sutures
- What is being tested?
- standardised video concerning clinical skill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteGermany
- Study dates
- 25 May 2021to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- medical student in the last year of the curriculum
Who cannot join
- no medical student in the last year of the curriculum
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Clinical Skills, Intra-osseous, Sutures, Education
- Being tested
- standardised video concerning clinical skill
- Keywords
- clinical skills, intraosseous access, Donati suture, imparting skills, education, undergraduate education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardised video concerning clinical skillOther
watching a video concerning clinical skills.
| Study group | Role | What they receive |
|---|---|---|
| video - then self-study | Other | 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). Receives: Other: standardised video concerning clinical skill |
| self-study, then video | Other | 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). Receives: Other: standardised video concerning clinical skill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Donati suture: "Task-Specific Score"
Score to quantify the particular skill: Minimum / worst performance 8, Max / best performance: 40
Measured: 1 week
Intraosseous venous access: "Intraosseous Access Performance Assessment Scale"
Score to quantify the particular skill: Minimum / worst performance 0, Max / best performance: 17
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start25 May 2021
- Primary completion11 Jun 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Clinical SkillsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Ott, Johannes Gutenberg University Mainz
- Investigators
- Sven-Oliver O. Dietz, M.D., Ph.D., Study director, Trauma Surgery / Zentrum für Orthopädie und Unfallchirurgie, Langebeckstr. 1, 55131 Mainz, GermanyThomas Ott, M.D., Study director, Department of Anaesthesiology / Klinik für Anästhesiologie, Langenbeckstr. 1, 55131 Mainz, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842357
- Sponsor's protocol ID
- UM-Nr. 21-00483
- Status last verified
- Aug 2021
- First submitted
- 6 Apr 2021
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will decide after ethical review board approval.
Publications
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.
PubMed 19643511Lee 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.
PubMed 17564692Shippey 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.
PubMed 19215895Shippey 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.
PubMed 21821220Oriot 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.
PubMed 22511182Ott 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.
PubMed 38956562
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04842357
- Acronym / sponsor ID
- UM-Nr. 21-00483
- Conditions
- Clinical Skills, Intra-osseous, Sutures, Education
- Keywords
- clinical skills, intraosseous access, Donati suture, imparting skills, education, undergraduate education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| video - then self-study | Other | Other: standardised video concerning clinical skillGroup 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). |
| self-study, then video | Other | Other: standardised video concerning clinical skillGroup 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- medical student in the last year of the curriculum
Key exclusion criteria (1 listed)
- no medical student in the last year of the curriculum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standardised video concerning clinical skillwatching a video concerning clinical skills. | Other | self-study, then video, video - then self-study |
Primary outcome
Donati suture: "Task-Specific Score"
Time frame: 1 week
Score to quantify the particular skill: Minimum / worst performance 8, Max / best performance: 40
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Background: PubMed 19643511Levitan 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.
- Background: PubMed 17564692Lee 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.
- Results publication: PubMed 19215895Shippey 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.
- Results publication: PubMed 21821220Shippey 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.
- Results publication: PubMed 22511182Oriot 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.
- Derived from this study: PubMed 38956562Ott 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.
- Individual participant dataSharing planned: Yes. We will decide after ethical review board approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven-Oliver O. Dietz, M.D., Ph.D. study director
Trauma Surgery / Zentrum für Orthopädie und Unfallchirurgie, Langebeckstr. 1, 55131 Mainz, Germany
Thomas Ott, M.D. study director
Department of Anaesthesiology / Klinik für Anästhesiologie, Langenbeckstr. 1, 55131 Mainz, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standardised video concerning clinical skill in people with Clinical Skills and Intra-osseous, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Donati suture: "Task-Specific Score" (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04842357, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.