Basic Life SupportNCT03141528
Self-learning vs Instructor-led Learning in BLS
A study testing Self-learning and Instructor-led learning in people with Basic Life Support, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
This study investigates whether there is a difference in the BLS skills in first year medical students directly after training and three months later, when randomly assigned to self-learning versus instructor-led training courses. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Basic Life Support
- What is being tested?
- Self-learning and Instructor-led learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Feb 2017to 7 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- First year medical students at the University of Bern participating in the course "Erweiterte Erste Hilfe für Studierende der Humanmedizin" with written informed consent.
Who cannot join
- Students with professional BLS-experience, unable to perform BLS, or missing informed consent will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-learning Versus Instructor-led Learning in Basic Life Support Training - A Randomized Controlled Trial
This study investigates whether there is a difference in the BLS skills in first year medical students directly after training and three months later, when randomly assigned to self-learning versus instructor-led training courses.
Read the detailed description
This is a randomized controlled trial investigating whether self-learning versus instructor-led learning results in the same BLS skills in first year medical students directly after training and three months later.
When participants attend the "Erweiterte Erste Hilfe für Studierende der Humanmedizin" they will receive a short introduction about the study. The investigators will invite all first year students to participate in the study. As the study is voluntarily, participants need to sign a written informed consent. After that, the investigators will randomize the students to either group A or Group B. Group A will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching) and group B will train without supervision. The participants in group B will not be allowed to communicate with each other during the training and they will be prevented from watching each other. The training will take about 30 minutes for each group. Directly after the training each group will be tested and the printed report form from the Laerdal Skill Reporter will be obtained for each participant. In the test the students will perform CPR in a simulated scenario as a first responder. The scenario is: "A male person has collapsed at the railway station." The participant should start CPR as learned in the training. During the CPR a departmental research fellow will observe the study participants and record BLS/AED actions on a scoring sheet.
The investigators will record three cycles of two minutes CPR (with five times 30:2 compression : ventilation intervals, as recommended by the current international resuscitation guidelines). During the three cycles an AED will be delivered and the study participant has to apply the AED and deliver a shock - after three cycles the study terminates.
After the BLS/AED competence testing, both groups will continue the rest of their first aid course together and the first part of the study ends. Three months later, the investigators will repeat the same scenario over the same time interval and record the same parameters. At the end of the second testing, a short feedback will be provided on the BLS/AED competence and further practice will be provided to the students to improve their CPR competence. From this point forward no further data will be collected.
- Conditions
- Basic Life Support
- Being tested
- Self-learning, Instructor-led learning
- Keywords
- Self-learning, Instructor-led learning, Long-term retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-learningOther
Training without supervision
Instructor-led learningOther
Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
| Study group | Role | What they receive |
|---|---|---|
| Instructor-led learning | Active comparator | This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching) Receives: Other: Instructor-led learning |
| Self-learning | Experimental | This group will Train alone without supervision and without communicating with the other participants. Receives: Other: Self-learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Correct Compressions
The percentage of correct compressions obtained from the printed report from the Laerdal Skill Reporter.
Measured: after first BLS course and 3 months later
Secondary outcomes (17)
Assessment of the Participants BLS Competences After Test
Assessment of the participant's BLS competence by the study team after test.
Rated on a Visual Analogue Scale from 0-100mm, where 0mm = completely incompetent, no idea what to do, and 100mm = totally competent, cannot be done better.
Measured: after first BLS course and 3 months later
Self-assessment of the Participants BLS Competences Before Test
The participants assessment of their own BLS competences. Rated on a Visual Analogue Scale from 0-100mm, where 0mm = completely incompetent, no idea what to do, and 100mm = totally competent, cannot be done better.
Measured: before first BLS course and 3 months later
Assessment of the Teaching Method
The participants assessment of the teaching method. Rated on a Visual Analogue Scale from 0-100mm, where 0mm = completely inefficient, and 100mm = totally efficient, nothing can be done better."
Measured: after first BLS course
Average Ventilation Volume
Ventilation volume from the printed report from the Laerdal Skill Reporter (LSR)
Measured: after first BLS course and 3 months later
Number of Ventilations Per Minute
Number of ventilations per minute from the printed report from the Laerdal Skill Reporter (LSR)
Measured: after first BLS course and 3 months later
Percentage of Correct Ventilations
Percentage of correct ventilations from the printed report from the Laerdal Skill Reporter (LSR)
Measured: after first BLS course and 3 months later
Number of Participants Using Correct Ratio of Compressions:Ventilations
the relationship between ventilations and compressions from the printed report from the Laerdal Skill Reporter (LSR). Ventilations - relationship 30 compressions and 2 ventilations.
Measured: after first BLS course and 3 months later
Compression Depth
Compression depth from the printed report from the Laerdal Skill Reporter (LSR)
Measured: after first BLS course and 3 months later
Number of Compressions Per Minute
Number of compressions per minute from the Laerdal Skill Reporter (LSR)
Measured: after first BLS course and 3 months later
Compression Frequency
Compression frequency from the Laerdal Skill Reporter (LSR). Compressions per minute ventilation break included.
Measured: after first BLS course and 3 months later
Compressions Too Shallow
Total percentage of Compressions too shallow from the Laerdal Skill Reporter (LSR)
Measured: after first BLS course and 3 months later
False Hand Placement During Compressions
False hand placement during compressions.
Measured: after first BLS course and 3 months later
Incomplete Decompression
Incomplete decompression from the Laerdal Skill Reporter (LSR)
Measured: after first BLS course and 3 months later
Time From Start of Test Till Call for Help
Time measured from the beginning of the test until the participant calls for help.
Measured: after first BLS course and 3 months later
Time From Start of Test Till First Compression
Time measured from the beginning of the test until the participant makes the first compression.
Measured: after first BLS course and 3 months later
Time From Start of Test Till First Ventilation
Time measured from the beginning of the test until the participant makes the first ventilation.
Measured: after first BLS course and 3 months later
Time From Start of Test Till First Shock
Time measured from the beginning of the test until the participant gives the first shock.
Measured: after first BLS course and 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start9 Feb 2017
- Primary completion2 Mar 2017
- Study completion7 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Basic Life SupportStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Robert Greif, MD, Principal investigator, University Hospital Bern Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141528
- Sponsor's protocol ID
- Req-2016-00071
- Status last verified
- Jan 2020
- First submitted
- 9 Feb 2017
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-learning Versus Instructor-led Learning in Basic Life Support Training - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03141528
- Acronym / sponsor ID
- Req-2016-00071
- Conditions
- Basic Life Support
- Keywords
- Self-learning, Instructor-led learning, Long-term retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 2 Mar 2017 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates whether there is a difference in the BLS skills in first year medical students directly after training and three months later, when randomly assigned to self-learning versus instructor-led training courses.
Detailed description
This is a randomized controlled trial investigating whether self-learning versus instructor-led learning results in the same BLS skills in first year medical students directly after training and three months later.
When participants attend the "Erweiterte Erste Hilfe für Studierende der Humanmedizin" they will receive a short introduction about the study. The investigators will invite all first year students to participate in the study. As the study is voluntarily, participants need to sign a written informed consent. After that, the investigators will randomize the students to either group A or Group B. Group A will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching) and group B will train without supervision. The participants in group B will not be allowed to communicate with each other during the training and they will be prevented from watching each other. The training will take about 30 minutes for each group. Directly after the training each group will be tested and the printed report form from the Laerdal Skill Reporter will be obtained for each participant. In the test the students will perform CPR in a simulated scenario as a first responder. The scenario is: "A male person has collapsed at the railway station." The participant should start CPR as learned in the training. During the CPR a departmental research fellow will observe the study participants and record BLS/AED actions on a scoring sheet.
The investigators will record three cycles of two minutes CPR (with five times 30:2 compression : ventilation intervals, as recommended by the current international resuscitation guidelines). During the three cycles an AED will be delivered and the study participant has to apply the AED and deliver a shock - after three cycles the study terminates.
After the BLS/AED competence testing, both groups will continue the rest of their first aid course together and the first part of the study ends. Three months later, the investigators will repeat the same scenario over the same time interval and record the same parameters. At the end of the second testing, a short feedback will be provided on the BLS/AED competence and further practice will be provided to the students to improve their CPR competence. From this point forward no further data will be collected.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instructor-led learning | Active comparator | Other: Instructor-led learningThis group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching) |
| Self-learning | Experimental | Other: Self-learningThis group will Train alone without supervision and without communicating with the other participants. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- First year medical students at the University of Bern participating in the course "Erweiterte Erste Hilfe für Studierende der Humanmedizin" with written informed consent.
Key exclusion criteria (1 listed)
- Students with professional BLS-experience, unable to perform BLS, or missing informed consent will be excluded.
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-learningTraining without supervision | Other | Self-learning |
| Instructor-led learningSupervision by a tutor (either general practitioner or medical student, all trained in CPR teaching) | Other | Instructor-led learning |
Primary outcome
Percentage of Correct Compressions
Time frame: after first BLS course and 3 months later
The percentage of correct compressions obtained from the printed report from the Laerdal Skill Reporter.
17 secondary outcomes
Assessment of the Participants BLS Competences After Test
Time frame: after first BLS course and 3 months later
Self-assessment of the Participants BLS Competences Before Test
Time frame: before first BLS course and 3 months later
Assessment of the Teaching Method
Time frame: after first BLS course
Average Ventilation Volume
Time frame: after first BLS course and 3 months later
Number of Ventilations Per Minute
Time frame: after first BLS course and 3 months later
Percentage of Correct Ventilations
Time frame: after first BLS course and 3 months later
Number of Participants Using Correct Ratio of Compressions:Ventilations
Time frame: after first BLS course and 3 months later
Compression Depth
Time frame: after first BLS course and 3 months later
Number of Compressions Per Minute
Time frame: after first BLS course and 3 months later
Compression Frequency
Time frame: after first BLS course and 3 months later
Compressions Too Shallow
Time frame: after first BLS course and 3 months later
False Hand Placement During Compressions
Time frame: after first BLS course and 3 months later
Incomplete Decompression
Time frame: after first BLS course and 3 months later
Time From Start of Test Till Call for Help
Time frame: after first BLS course and 3 months later
Time From Start of Test Till First Compression
Time frame: after first BLS course and 3 months later
Time From Start of Test Till First Ventilation
Time frame: after first BLS course and 3 months later
Time From Start of Test Till First Shock
Time frame: after first BLS course and 3 months later
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Basic Life Support
Recruiting
Evaluation of Mixed Reality Cardiopulmonary Resuscitation Training
Cardiopulmonary Resuscitation (CPR), Basic Life Support Training Course
Active, not recruiting
Supporting Tools and Cognitive Aids for BLS
Basic Life Support (Simulation)
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.
Robert Greif, MD principal investigator
University Hospital Bern Inselspital
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-learning and Instructor-led learning in people with Basic Life Support, 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 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 13 Jan 2020. 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?
Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Correct Compressions (time frame: after first BLS course and 3 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2020; AzTrials last refreshed its copy on 27 Oct 2026.