Professional RoleEVALUATINGNCT05530382
Self-guided vs Traditional Instructor-led Learning for Medical Device Training
A study testing self-guided learning in people with Professional Role and Interprofessional Education, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The aim of this study project is to clarify whether defined practical application skills are learned by anesthesiology specialists through a self-directed learning program with learning videos and a hands-on exercise station ("intervention group"). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Professional Role, Interprofessional Education, Simulation Training
- What is being tested?
- self-guided learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteSwitzerland
- Study dates
- 4 Oct 2022to 1 Apr 2024
- 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
- Clinical working anaesthesia staff of the Department of Anaesthesia and Pain Medicine, Bern University Hospital
- written consent
Who cannot join
- not fulfilling inclusion criteria
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland
Bern, 3010
About this study
Official title: Comparing Self-guided Learning (Video and hands-on Simulation) With Traditional Instructor-led Learning for Medical Device Training: a Randomized-controlled Trial
The aim of this study project is to clarify whether defined practical application skills are learned by anesthesiology specialists through a self-directed learning program with learning videos and a hands-on exercise station ("intervention group"). "Control group" is a traditional instructor-led practical workshop classroom teaching.
Hypothesis: A video-based and self-directed learning program shows no difference in the learning successes than traditional face-to-face workshops.
Read the detailed description
The Department of Anaesthesiology and Pain Medicine is going to buy and introduce a new generation of anaesthetic machines. Therefore the whole clinical staff of the department who will operate the new anaesthetic machine in the future must be educated and trained with this device before working with patients.
Continuous professional training in the use of medical devices is an essential part of developing professional skills, including in anaesthesia. The professional, routine use of devices is essential to guarantee patient safety. The usual instructor-led workshop-based equipment training in face-to-face lessons is time-consuming and resource-intensive. The high work intensity and shift work in anaesthesia pose a challenge for such training courses. Video-supported learning sequences were more effective than traditional face-to-face lessons, especially for procedural - cognitive processes of complex psychomotor skills. Self-controlled practical practice is more effective than externally controlled practice conditions.
The aim of this study is to clarify whether defined practical application skills (anaesthetic machine) are learned by anesthesiology specialists (nurses and physicians of the department) through a self-directed learning program with learning videos and a hands-on exercise station ("intervention group"). "Control group" is a traditional instructor-led practical workshop classroom teaching.
- The null hypothesis (H0) is that a video-based and self-directed learning program shows no difference in the learning success than traditional face-to-face workshops
The aim of this study is to clarify whether anesthesiologists and nurses anaesthetists can learn defined practical application skills through a self-directed learning program with learning videos and a hands-on training station. If this educational research project is able to demonstrate that self-guided learning of complex psychomotor skills needed for the handling of medical devices like respirators is non-inferior to traditional classroom teaching of such skills, this might minimize the dependence on traditional educator-driven resource-intensive workshop teaching and has the potential to change clinical teaching in the future. The educational topic of the study is "device training in the hospital sector".
A randomized controlled comparative study with two groups (face-to-face workshop versus video-based self-directed learning) in a non-inferiority design is planned, assuming a non-inferior success rate of the traditional face-to-face workshop of 80% and a non-inferiority range of 10%. According to a sample size calculation, 224 voluntary participants are needed.
- Being tested
- self-guided learning
- Keywords
- Teaching Methods, Learning Methods, Self-Directed Learning, Continuing Medical Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-guided learningOther
video-based self-directed learning for medical device training
| Study group | Role | What they receive |
|---|---|---|
| self-guided learning (video and hands-on simulation) | Experimental | video-based self-directed learning Receives: Other: self-guided learning |
| traditional instructor-led learning | No intervention | traditional instructor-led learning in face-to-face workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Application skills achieved in the context of an objective structured clinical examination (OSCE) test station per participant (yes or no)
Achieved or not achieved based on defined practical assignments and oral questioning using a defined catalogue of questions. The testing is carried out by an expert trained as a key user. The test is rated as successful if 60% or more of the questions are answered successfully.
The following four criteria are checked:
- Working principle
- Security aspect
- Handling and operation
- Theory-practice transfer
Each criterion is assessed with 0-3 points 0 = does not apply
- = rather does not apply
- = applies
- = applies very well
The final evaluation of the device test is based on the following granulated scale:
A - 100% of the criteria (excellent) B 90% - 99% (very good) C 80% - 89% (good) D 70% - 79% (satisfactory) E 60% - 69% (sufficient) F <60% (unsatisfactory)
Measured: 10 minutes
Secondary outcomes (5)
level of application skills
Application skills scaled (excellent (A) to unsatisfactory (F), measured from the data from the test station.
The final evaluation of the device test is based on the following granulated scale:
A - 100% of the criteria (excellent) B 90% - 99% (very good) C 80% - 89% (good) D 70% - 79% (satisfactory) E 60% - 69% (sufficient) F <60% (unsatisfactory)
Measured: 10 minutes
open questions after the training
Participants will report in a survey if they have any unanswered questions after the training. The number (n) of unanswered questions and percentages will be given for each arm
Measured: 1 day
Time spent
Participants will report in a survey on their time spent for learning. Time will be reported in minutes for each arm per participant.
Measured: 1 day
use of resources
Use of resources in both teaching formats (e.g., books, internet, other teaching material). The outcome will be reported in numbers and percentages.
Measured: 1 day
cost comparison
Cost comparison between the two learning formats. For traditional learning e.g. cost for the instructor and facility. For video-guided learning e.g. costs for the production of the video. The outcome will be reported in Swiss Francs.
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 posted7 Sep 2022
- Study start4 Oct 2022
- Primary completion1 Mar 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Professional RoleStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Greif Robert, MD, MME, Professor, Study director, University of BerneCaterina Gutersohn, RN, NA, Principal investigator, University of Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530382
- Sponsor's protocol ID
- Videolearning
- Acronym
- EVALUATING
- Status last verified
- May 2024
- First submitted
- 2 Sep 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All relevant data will be published
Publications
Gutersohn C, Schweingruber S, Haudenschild M, Huber M, Greif R, Fuchs A. Self-directed learning versus traditional instructor-led learning for education on a new anaesthesia workstation: a noninferiority, randomised, controlled trial. Br J Anaesth. 2025 Oct;135(4):990-996. doi: 10.1016/j.bja.2025.03.043. Epub 2025 May 22.
PubMed 40410098Gutersohn C, Schweingruber S, Haudenschild M, Huber M, Greif R, Fuchs A. Medical device education: study protocol for a randomised controlled trial comparing self-directed learning with traditional instructor-led learning on an anaesthesia workstation. BMJ Open. 2023 Sep 4;13(9):e070261. doi: 10.1136/bmjopen-2022-070261.
PubMed 37666557
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Self-guided Learning (Video and hands-on Simulation) With Traditional Instructor-led Learning for Medical Device Training: a Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT05530382
- Acronym / sponsor ID
- EVALUATING / Videolearning
- Keywords
- Teaching Methods, Learning Methods, Self-Directed Learning, Continuing Medical Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 7 Sep 2022 (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.
The aim of this study project is to clarify whether defined practical application skills are learned by anesthesiology specialists through a self-directed learning program with learning videos and a hands-on exercise station ("intervention group"). "Control group" is a traditional instructor-led practical workshop classroom teaching.
Hypothesis: A video-based and self-directed learning program shows no difference in the learning successes than traditional face-to-face workshops.
Detailed description
The Department of Anaesthesiology and Pain Medicine is going to buy and introduce a new generation of anaesthetic machines. Therefore the whole clinical staff of the department who will operate the new anaesthetic machine in the future must be educated and trained with this device before working with patients.
Continuous professional training in the use of medical devices is an essential part of developing professional skills, including in anaesthesia. The professional, routine use of devices is essential to guarantee patient safety. The usual instructor-led workshop-based equipment training in face-to-face lessons is time-consuming and resource-intensive. The high work intensity and shift work in anaesthesia pose a challenge for such training courses. Video-supported learning sequences were more effective than traditional face-to-face lessons, especially for procedural - cognitive processes of complex psychomotor skills. Self-controlled practical practice is more effective than externally controlled practice conditions.
The aim of this study is to clarify whether defined practical application skills (anaesthetic machine) are learned by anesthesiology specialists (nurses and physicians of the department) through a self-directed learning program with learning videos and a hands-on exercise station ("intervention group"). "Control group" is a traditional instructor-led practical workshop classroom teaching.
- The null hypothesis (H0) is that a video-based and self-directed learning program shows no difference in the learning success than traditional face-to-face workshops
The aim of this study is to clarify whether anesthesiologists and nurses anaesthetists can learn defined practical application skills through a self-directed learning program with learning videos and a hands-on training station. If this educational research project is able to demonstrate that self-guided learning of complex psychomotor skills needed for the handling of medical devices like respirators is non-inferior to traditional classroom teaching of such skills, this might minimize the dependence on traditional educator-driven resource-intensive workshop teaching and has the potential to change clinical teaching in the future. The educational topic of the study is "device training in the hospital sector".
A randomized controlled comparative study with two groups (face-to-face workshop versus video-based self-directed learning) in a non-inferiority design is planned, assuming a non-inferior success rate of the traditional face-to-face workshop of 80% and a non-inferiority range of 10%. According to a sample size calculation, 224 voluntary participants are needed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| self-guided learning (video and hands-on simulation) | Experimental | Other: self-guided learningvideo-based self-directed learning |
| traditional instructor-led learning | No intervention | –traditional instructor-led learning in face-to-face workshop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical working anaesthesia staff of the Department of Anaesthesia and Pain Medicine, Bern University Hospital
- written consent
Key exclusion criteria (1 listed)
- not fulfilling inclusion criteria
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 |
|---|---|---|
| self-guided learningvideo-based self-directed learning for medical device training | Other | self-guided learning (video and hands-on simulation) |
Primary outcome
Application skills achieved in the context of an objective structured clinical examination (OSCE) test station per participant (yes or no)
Time frame: 10 minutes
Achieved or not achieved based on defined practical assignments and oral questioning using a defined catalogue of questions. The testing is carried out by an expert trained as a key user. The test is rated as successful if 60% or more of the questions are answered successfully. The following four criteria are checked: * Working principle * Security aspect * Handling and operation * Theory-practice transfer Each criterion is assessed with 0-3 points 0 = does not apply 1. = rather does not apply 2. = applies 3. = applies very well The final evaluation of the device test is based on the following granulated scale: A - 100% of the criteria (excellent) B 90% - 99% (very good) C 80% - 89% (good) D 70% - 79% (satisfactory) E 60% - 69% (sufficient) F <60% (unsatisfactory)
5 secondary outcomes
level of application skills
Time frame: 10 minutes
open questions after the training
Time frame: 1 day
Time spent
Time frame: 1 day
use of resources
Time frame: 1 day
cost comparison
Time frame: 1 day
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 8 May 2024.
- Derived from this study: PubMed 40410098Gutersohn C, Schweingruber S, Haudenschild M, Huber M, Greif R, Fuchs A. Self-directed learning versus traditional instructor-led learning for education on a new anaesthesia workstation: a noninferiority, randomised, controlled trial. Br J Anaesth. 2025 Oct;135(4):990-996. doi: 10.1016/j.bja.2025.03.043. Epub 2025 May 22.
- Derived from this study: PubMed 37666557Gutersohn C, Schweingruber S, Haudenschild M, Huber M, Greif R, Fuchs A. Medical device education: study protocol for a randomised controlled trial comparing self-directed learning with traditional instructor-led learning on an anaesthesia workstation. BMJ Open. 2023 Sep 4;13(9):e070261. doi: 10.1136/bmjopen-2022-070261.
- Individual participant dataSharing planned: No. All relevant data will be published
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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.
Greif Robert, MD, MME, Professor study director
University of Berne
Caterina Gutersohn, RN, NA principal investigator
University of Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-guided learning in people with Professional Role and Interprofessional Education, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 8 May 2024. 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 Switzerland. 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?
Application skills achieved in the context of an objective structured clinical examination (OSCE) test station per participant (yes or no) (time frame: 10 minutes). 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 NCT05530382, which also lists 2 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 8 May 2024.