Plain English Summary
Background and study aims
Anaphylactic shock is a severe and potentially life-threatening reaction to a trigger such as an allergy. It is a rare medical situation and primary care doctors do not encounter it often. It needs to be recognised and managed quickly and appropriately, so it is essential that the doctor knows what to do and is confident in their knowledge. The aim of this study is to investigate whether using augmented reality simulation in training doctors how to recognize and manage a patient with anaphylactic shock will improve their confidence in managing these situations.
Who can participate?
Family medicine doctors
What does the study involve?
Participants will be randomly allocated to the test and control group. Both groups will receive one day of training on management of patients with anaphylactic shock. The test group will also receive additional training using augmented reality.
What are the possible benefits and risks of participating?
The benefits are learning in a safe environment to manage a patient with anaphylactic shock, allowing the doctors to recognise their own lack of knowledge, skills and competencies and being able to overcome them, recognise safety risks when managing such patients, learn to work in a team, learning to cope with the stress and perform well also under stress. The risks include exposing their knowledge, skills and competencies before other people. Also the training is potentially time-consuming.
Where is the study run from?
Community Health Centre Ljubljana (Slovenia)
When is the study starting and how long is it expected to run for?
September 2019 to December 2021
Who is funding the study?
The researchers are funding the study.
Who is the main contact?
Prof. Zalika Klemenc-Ketis, email@example.com
The effect of the use of augmented reality in teaching anaphylactic shock management at the primary health care level: a randomised controlled trial
Learning of the management of anaphylactic shock with the use of augmented reality is more effective than learning without this method.
Current ethics approval as of 06/04/2020:
Approved 27/02/2020, Komisija Republike Slovenija za medicinsko etiko [National Ethics Committee of Slovenia] (Štefanova ulica 5, 1000 Ljubljana, Slovenia; +386 01 478 60 01; firstname.lastname@example.org), ref: 0120-67/2020/7
Previous ethics approval:
Approval pending, the National Ethics Committee of Slovenia
Randomized controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Learning the management of anaphylactic shock at the primary health care level
The participants (family medicine physicians) will be classified into two groups on the basis of a random selection: test and control. Each participant will receive a consecutive number upon enrolling to the study. These numbers will then be used in a randomisation process using random numbers selection by the computer program.
Both groups will complete a questionnaire on demographic characteristics and coping with stress and manage a patient with anaphylactic shock (drug allergy shock) using a high-fidelity simulator. Thereafter, both groups will receive one-day training following a pre-prepared protocol.
The test team will have additional augmented reality education included in the training.
Immediately after completion of the training, both groups will complete a questionnaire on coping with stress and provide care to the patient with anaphylactic shock using a high-fidelity simulator. 6 and 12 months after the education, both groups will complete a stress response questionnaire and manage a patient with anaphylactic shock using a standardised patient, but this care will be provided in a clinical setting.
Primary outcome measure
The management of a patient with anaphylactic shock. The evaluation will be done using the high-fidelity simulators with a pre-prepared scenario and with the use of a standardised patient with a pre-prepared scenario. The evaluation will be done before the education process, immediately after it, 6 months afterwards and 1 year afterwards.
Secondary outcome measures
Coping with stress assessed using the Ways of Coping Questionnaire (WCQ) before the education process, immediately after it, 6 months afterwards and 1 year afterwards
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Family medicine physician
2. Willing to participate in the study
Target number of participants
310 (150 in the test group and 160 in the control group).
Participant exclusion criteria
2. Not willing to participate in the study
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Community Health Centre Ljubljana
Investigator initiated and funded
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
1. A protocol of the study (JMIR Research Protocols), in 2020.
2. A doctoral thesis in 2021.
3. The effect of using the augmented reality, in 2021.
4. Coping with stress (in 2021).
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request
Intention to publish date
Participant level data
Available on request
Basic results (scientific)