Condition category
Circulatory System
Date applied
04/03/2019
Date assigned
07/03/2019
Last edited
07/03/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes

07/03/2019: No third-party confirmation of trial’s existence available as the trial did not require ethics approval.