The use of augmented reality to teach management of severe allergic reaction to health care professionals
| ISRCTN | ISRCTN58047410 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58047410 |
| Secondary identifying numbers | 1 |
- Submission date
- 17/12/2019
- Registration date
- 16/01/2020
- Last edited
- 18/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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 June 2025
Who is funding the study?
The researchers are funding the study.
Who is the main contact?
Prof. Zalika Klemenc-Ketis, zalika.klemenc@um.si
Contact information
Scientific
Metelkova 9
Ljubljana
1000
Slovenia
 ORCID ID |
0000-0002-0270-1754 |
|---|---|
| Phone | +38641516067 |
| zalika.klemenc@um.si |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| 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 |
| Study objectives | Learning of the management of anaphylactic shock with the use of augmented reality is more effective than learning without this method. |
| Ethics approval(s) |
Approved 27/02/2020, Slovenian Ethical Committee (Štefanova 5, Ljubljana, 1000, Slovenia; +386 01 478 60 01; gp.mz@gov.si), ref: 0120-67/2020/7 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2019 |
| Completion date | 30/06/2025 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 109 |
| Key inclusion criteria | 1. Family medicine physician 2. Willing to participate in the study |
| Key exclusion criteria | 1. Students 2. Not willing to participate in the study |
| Date of first enrolment | 01/10/2020 |
| Date of final enrolment | 30/06/2024 |
Locations
Countries of recruitment
- Slovenia
Study participating centre
Ljubljana
1000
Slovenia
Sponsor information
Hospital/treatment centre
Metelkova 9
Ljubljana
1000
Slovenia
| Phone | +38613003928 |
|---|---|
| taj.irroz@zd-lj.si | |
| Website | https://www.zd-lj.si/ |
"ROR" |
https://ror.org/04fx4vz25 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publications: 1. A protocol of the study (JMIR Research Protocols) 2. A doctoral thesis 3. The effect of using the augmented reality 4. Coping with stress |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 04/01/2021 | 05/01/2021 | Yes | No |
Editorial Notes
18/06/2024: The following changes were made:
1. The target number of participants was changed from "310 (150 in the test group and 160 in the control group)" to "150".
2. The total final enrolment was added.
11/01/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/01/2024 to 30/06/2024.
2. The overall end date was changed from 31/12/2024 to 30/06/2025.
3. The plain English summary was updated to reflect these changes.
14/06/2023: The recruitment end date was changed from 30/06/2023 to 31/01/2024.
19/12/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2022 to 30/06/2023.
2. The overall end date was changed from 31/12/2023 to 31/12/2024.
3. The intention to publish date was changed from 30/06/2023 to 31/12/2025.
4. The plain English summary was updated to reflect these changes.
04/07/2022: The recruitment end date was changed from 30/06/2022 to 31/12/2022.
11/11/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/11/2021 to 30/06/2022.
2. The overall end date was changed from 01/11/2022 to 31/12/2023.
3. The intention to publish date was changed from 31/12/2022 to 30/06/2023.
4. The plain English summary was updated to reflect these changes.
16/04/2021: The following changes have been made:
1. The recruitment end date has been changed from 01/04/2021 to 01/11/2021.
2. The overall trial end date has been changed from 01/04/2022 to 01/11/2022 and the plain English summary has been updated to reflect this change.
12/02/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/02/2021 to 01/04/2021.
2. The overall trial end date was changed from 01/02/2022 to 01/04/2022.
05/01/2021: Publication reference added.
04/11/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/11/2020 to 01/02/2021.
2. The overall end date was changed from 31/12/2021 to 01/02/2022.
3. The intention to publish date was changed from 31/05/2022 to 31/12/2022.
4. The plain English summary was updated to reflect these changes.
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].
