Plain English Summary
Background and study aims
In Germany it is recommended for school children to receive basic life support (BLS) training. Even trained people often hesitate to help in cardiac arrest. This study investigates if special training methods are effective at improving school children's preparedness and positive beliefs in their own capability to help in cardiac arrest.
Who can participate?
Students in grade seven and eight at high schools in Hamburg
What does the study involve?
Classes are randomly allocated to either the intervention group or the control group. All classes participate in practical training in BLS. The intervention group receive self-regulated training in peer groups after demonstration and deconstruction of the steps by the trainer. The control group receive Instructor-led training following the four-step approach. Self-efficacy for helping in cardiac arrest is measured immediately after the training and 9 months later.
What are the possible benefits and risks of participating?
Participants receive training in first aid, and no risks are expected.
Where is the study run from?
University Medical Center Hamburg-Eppendorf (Germany)
When is the study starting and how long is it expected to run for?
February 2015 to October 2017
Who is funding the study?
University Medical Center Hamburg-Eppendorf (Germany)
Who is the main contact?
Dr Stefanie Beck
st.beck@uke.de
Trial website
Contact information
Type
Public
Primary contact
Dr Stefanie Beck
ORCID ID
Contact details
Department of Anaesthesiology
University Medical Center Hamburg-Eppendorf
Martini-Str. 52
Hamburg
20246
Germany
+49 (0)40741052415
st.beck@uke.de
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Promotes self-regulated learning in peer- groups self-efficacy for helping in cardiac arrest?
Acronym
Sicher im Ernstfall
Study hypothesis
Self-regulated learning in peer- groups promotes self-efficacy and long-term retention of practical Basic Life support (BLS) skills in school children.
Ethics approval
The study was rated by the head of the local Ethics Committee of the Medical Association of Hamburg as a study with humans but not on humans. Therefore, this educational study does not refer to the statutes of the ethics committee (§ 9 des Hamburgischen Kammergesetzes für Heilberufe) and the study was not appropriate for ethics consultation. This study was conducted with the approval of the Ministry of education of the state of Hamburg (Ministerium für Schule und Weiterbildung des Landes Hamburg).
Study design
Prospective randomised controlled interventional trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Other
Patient information sheet
not available in web format, please use contact details to request a participant information sheet
Condition
Helping in cardiac arrest
Intervention
Students were randomised class-wise into the intervention and control arm in a 1:1 allocation ratio. The randomisation was performed in advance by drawing balls of two colours blindly. A cluster was represented by students of one class.
All students participated in a practical training in BLS and an objective structured examination of skills:
Intervention: Basic Life support training with self-regulated training in peer-groups after demonstration and deconstruction of the steps by the trainer
Control: Instructor-led basic life support training following the four-step approach
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Self-efficacy of school children for helping in cardiac arrest, measured with a four-point Likert scale in three dimensions with two questions for each by adding the values of the two questions. The dimensions were helping in general, helping in cardiac arrest and diminished emotional arousal to cardiac arrest. The questionnaire, based on the general self-efficacy scale of Schwarzer and Jerusalem, was transformed into a special self-efficacy scale following the authors recommendations. Measured immediately after the training and 9 months later.
Secondary outcome measures
Pass-rates and means for items in a practical basis life support assessment. The assessment of the practical BLS skills was structured as an OSCE using MiniAnne-mannequins® (LaerdalTM). For assessment, the raters used a structured rating checklist with nine binary items. To pass the practical assessment in total, all nine points had to be rated with yes. Measured immediately after the training and 9 months later.
Overall trial start date
04/02/2015
Overall trial end date
31/10/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Volunteering school children
2. Written informed consent of the parents
Participant type
Healthy volunteer
Age group
Child
Gender
Both
Target number of participants
15 classes (clusters) with a mean number of 22 students per class for every group (15 x 22 x 2)
Participant exclusion criteria
1. Not able to perform basic life support
2. No written informed consent from the parents
Recruitment start date
01/07/2016
Recruitment end date
01/09/2016
Locations
Countries of recruitment
Germany
Trial participating centre
University Medical Center Hamburg-Eppendorf
Department of Anaesthesiology
Martini-Str. 52
Hamburg
20246
Germany
Sponsor information
Organisation
University Medical Center Hamburg-Eppendorf
Sponsor details
Department of Anaesthesiology
Martini-Str. 52
Hamburg
20246
Germany
+49 (0)40741052415
st.beck@uke.de
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in an open access medical journal.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Stefanie Beck (st.beck@uke.de). The final dataset used for analyses could be provided, data are anonymised, consent to publish anonymised result obtained by all participants.
Intention to publish date
15/03/2019
Participant level data
Available on request
Basic results (scientific)
Publication list