- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03141528
Self-learning vs Instructor-led Learning in BLS
Self-learning Versus Instructor-led Learning in Basic Life Support Training - A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bern, Switzerland, 3010
- University Hospital Inselspital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- First year medical students at the University of Bern participating in the course "Erweiterte Erste Hilfe für Studierende der Humanmedizin" with written informed consent.
Exclusion Criteria:
- Students with professional BLS-experience, unable to perform BLS, or missing informed consent will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Instructor-led learning
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
|
Experimental: Self-learning
This group will Train alone without supervision and without communicating with the other participants.
|
Training without supervision
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
after first BLS course and 3 months later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the Participants BLS Competences After Test
Time Frame: after first BLS course and 3 months later
|
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. |
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
|
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.
|
before first BLS course and 3 months later
|
Assessment of the Teaching Method
Time Frame: after first BLS course
|
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."
|
after first BLS course
|
Average Ventilation Volume
Time Frame: after first BLS course and 3 months later
|
Ventilation volume from the printed report from the Laerdal Skill Reporter (LSR)
|
after first BLS course and 3 months later
|
Number of Ventilations Per Minute
Time Frame: after first BLS course and 3 months later
|
Number of ventilations per minute from the printed report from the Laerdal Skill Reporter (LSR)
|
after first BLS course and 3 months later
|
Percentage of Correct Ventilations
Time Frame: after first BLS course and 3 months later
|
Percentage of correct ventilations from the printed report from the Laerdal Skill Reporter (LSR)
|
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
|
the relationship between ventilations and compressions from the printed report from the Laerdal Skill Reporter (LSR).
Ventilations - relationship 30 compressions and 2 ventilations.
|
after first BLS course and 3 months later
|
Compression Depth
Time Frame: after first BLS course and 3 months later
|
Compression depth from the printed report from the Laerdal Skill Reporter (LSR)
|
after first BLS course and 3 months later
|
Number of Compressions Per Minute
Time Frame: after first BLS course and 3 months later
|
Number of compressions per minute from the Laerdal Skill Reporter (LSR)
|
after first BLS course and 3 months later
|
Compression Frequency
Time Frame: after first BLS course and 3 months later
|
Compression frequency from the Laerdal Skill Reporter (LSR).
Compressions per minute ventilation break included.
|
after first BLS course and 3 months later
|
Compressions Too Shallow
Time Frame: after first BLS course and 3 months later
|
Total percentage of Compressions too shallow from the Laerdal Skill Reporter (LSR)
|
after first BLS course and 3 months later
|
False Hand Placement During Compressions
Time Frame: after first BLS course and 3 months later
|
False hand placement during compressions.
|
after first BLS course and 3 months later
|
Incomplete Decompression
Time Frame: after first BLS course and 3 months later
|
Incomplete decompression from the Laerdal Skill Reporter (LSR)
|
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 measured from the beginning of the test until the participant calls for help.
|
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 measured from the beginning of the test until the participant makes the first compression.
|
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 measured from the beginning of the test until the participant makes the first ventilation.
|
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
|
Time measured from the beginning of the test until the participant gives the first shock.
|
after first BLS course and 3 months later
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Robert Greif, MD, University Hospital Bern Inselspital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Req-2016-00071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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