Complication of InfusionNCT05066204
Evaluation of Different Teaching- and Learningmethods
A study testing Sequence of teaching-/learningmethod in people with Complication of Infusion and Education, Medical, 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. The investigators explored this aspect in spring 2021 concerning the humeral intraosseous access. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Complication of Infusion, Education, Medical
- What is being tested?
- Sequence of teaching-/learningmethod
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 17 May 2021to 29 Mar 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- voluteer medical students in their last year of medical school (i.e. after 2nd state board in Germany)
- writen informed consert
Who cannot join
- denial of participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Different Teaching- and Learningmethods Concerning the Humeral Intraosseal Access in Inexperienced Providers
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.
Read the detailed description
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
- Conditions
- Complication of Infusion, Education, Medical
- Being tested
- Sequence of teaching-/learningmethod
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequence of teaching-/learningmethodOther
see: arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Sequence: self-study, then teaching video | Other | Participants first do self-study, then right afterwards watch a teaching video, then become tested on a simulator and are videorecorded for evaluation Receives: Other: Sequence of teaching-/learningmethod |
| Sequence: teaching video, then self study | Other | Participants first watch a teaching video, then do self-study, then become tested on a simulator and are videorecorded for evaluation Receives: Other: Sequence of teaching-/learningmethod |
What is being measured
The primary outcome is the main question the study is designed to answer.
sum of score
sum of the score used to evaluate the particpants' performance by video records
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start17 May 2021
- Primary completion10 Dec 2021
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complication of InfusionStudies 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
- Parallel groups
- Model description
- Two unbound samples running through a different sequence of teching-/learningmethods
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066204
- Sponsor's protocol ID
- 2021-16112 EK RLP
- Status last verified
- Mar 2022
- First submitted
- 23 Sep 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38956562
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Teaching- and Learningmethods Concerning the Humeral Intraosseal Access in Inexperienced Providers
- ClinicalTrials.gov ID
- NCT05066204
- Acronym / sponsor ID
- 2021-16112 EK RLP
- Conditions
- Complication of Infusion, Education, Medical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 4 Oct 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. 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.
Detailed description
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Two unbound samples running through a different sequence of teching-/learningmethods
| Arm | Type | Receives |
|---|---|---|
| Sequence: self-study, then teaching video | Other | Other: Sequence of teaching-/learningmethodParticipants first do self-study, then right afterwards watch a teaching video, then become tested on a simulator and are videorecorded for evaluation |
| Sequence: teaching video, then self study | Other | Other: Sequence of teaching-/learningmethodParticipants first watch a teaching video, then do self-study, then become tested on a simulator and are videorecorded for evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- voluteer medical students in their last year of medical school (i.e. after 2nd state board in Germany)
- writen informed consert
Key exclusion criteria (1 listed)
- denial of participation
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 |
|---|---|---|
| Sequence of teaching-/learningmethodsee: arm/group descriptions | Other | Sequence: self-study, then teaching video, Sequence: teaching video, then self study |
Primary outcome
sum of score
Time frame: 1 Day
sum of the score used to evaluate the particpants' performance by video records
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 7 Apr 2022.
- 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: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequence of teaching-/learningmethod in people with Complication of Infusion and Education, Medical, 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 2 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 7 Apr 2022. 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?
sum of score (time frame: 1 Day). 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 NCT05066204, which also lists 1 linked publication.
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 7 Apr 2022.