Condition category
Not Applicable
Date applied
17/12/2019
Date assigned
16/01/2020
Last edited
06/04/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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, zalika.klemenc@um.si

Trial website

Contact information

Type

Scientific

Primary contact

Prof Zalika Klemenc-Ketis

ORCID ID

https://orcid.org/0000-0002-0270-1754

Contact details

Metelkova 9
Ljubljana
1000
Slovenia
+38641516067
zalika.klemenc@um.si

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

1

Study information

Scientific title

The effect of the use of augmented reality in teaching anaphylactic shock management at the primary health care level: a randomised controlled trial

Acronym

Study hypothesis

Learning of the management of anaphylactic shock with the use of augmented reality is more effective than learning without this method.

Ethics approval

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; gp.mz@gov.si), ref: 0120-67/2020/7

Previous ethics approval:
Approval pending, the National Ethics Committee of Slovenia

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Learning the management of anaphylactic shock at the primary health care level

Intervention

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.

Intervention type

Behavioural

Phase

Drug names

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

01/09/2019

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Family medicine physician
2. Willing to participate in the study

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

310 (150 in the test group and 160 in the control group).

Participant exclusion criteria

1. Students
2. Not willing to participate in the study

Recruitment start date

01/10/2020

Recruitment end date

01/11/2020

Locations

Countries of recruitment

Slovenia

Trial participating centre

Community Health Centre Ljubljana
Metelkova 9
Ljubljana
1000
Slovenia

Sponsor information

Organisation

Community Health Centre Ljubljana

Sponsor details

Metelkova 9
Ljubljana
1000
Slovenia
+38613003928
taj.irroz@zd-lj.si

Sponsor type

Hospital/treatment centre

Website

https://www.zd-lj.si/

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 publications:
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

31/05/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/04/2020: The following changes have been made: 1. The ethics approval has been updated. 2. The intention to publish date has been changed from 01/06/2020 to 31/05/2022. 03/04/2020: The following changes have been made: 1. The recruitment start date has been changed from 01/03/2020 to 01/10/2020. 2. The recruitment end date has been changed from 31/03/2020 to 01/11/2020. 16/01/2020: Trial's existence confirmed by the Zdravstveni dom Ljubljana [Community Health Centre Ljubljana].