Nursing EducationARNCT05446896
Effectiveness of AR in Ventilator Setting Education.
A study testing AR guidance with Hololens 2 in people with Nursing Education, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study aimed to determine the feasibility and effectiveness of an augmented reality (AR)-based self-learning platform for novices to set up a ventilator without on-site assistance. This was a prospective randomized controlled pilot study conducted at Samsung Medical Center, Korea from January to February 2022. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nursing Education
- What is being tested?
- AR guidance with Hololens 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Jan 2022to 28 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- We enrolled nurses who had no prior experience with ventilator setup or AR systems, regardless of their work department or age.
Who cannot join
- We excluded nurses who had already experienced setting up a ventilator or who had trouble wearing or using a head-mounted device (HMD).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Setting-up Of A Mechanical Ventilator With An Augmented Reality Guide: A Prospective, Randomized Pilot Trial
This study aimed to determine the feasibility and effectiveness of an augmented reality (AR)-based self-learning platform for novices to set up a ventilator without on-site assistance. This was a prospective randomized controlled pilot study conducted at Samsung Medical Center, Korea from January to February 2022. Nurses with no prior experience of MV or AR were enrolled. We randomized the participants into two groups: manual and AR groups. Participants in the manual group used a printed manual and made a phone call for assistance, whereas participants in the AR group were guided by AR-based instructions and requested assistance with the head-mounted device (HMD). We compared the overall score of the procedure, required level of assistance, and user's experience between the groups.
Read the detailed description
Background: Recently, the demand for mechanical ventilation (MV) has increased with the COVID-19 pandemic; however, the conventional approaches to MV training are resource-intensive and require on-site training. Consequently, the need for independent learning platforms with remote assistance in institutions without resources has surged.
Objective:
This study aimed to determine the feasibility and effectiveness of an augmented reality (AR)-based self-learning platform for novices to set up a ventilator without on-site assistance.
Method:
This was a prospective randomized controlled pilot study conducted at Samsung Medical Center, Korea from January to February 2022. Nurses with no prior experience of MV or AR were enrolled. We randomized the participants into two groups: manual and AR groups. Participants in the manual group used a printed manual and made a phone call for assistance, whereas participants in the AR group were guided by AR-based instructions and requested assistance with the head-mounted device (HMD). We compared the overall score of the procedure, required level of assistance, and user's experience between the groups.
- Conditions
- Nursing Education
- Being tested
- AR guidance with Hololens 2
- Keywords
- Ventilator, Nursing, Education, Augmented reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR guidance with Hololens 2Device
The AR instructions were developed as a step-by-step guide with the same text and images as in the printed manual, utilizing the dynamic 365 Guide (Software, Microsoft Corporation, Redmond, WA, USA). The AR instructions were delivered using the Microsoft HoloLens 2.
| Study group | Role | What they receive |
|---|---|---|
| AR group | Experimental | participants in the AR group were guided by AR-based instructions and requested assistance with the head-mounted device. Receives: Device: AR guidance with Hololens 2 |
| manual group | No intervention | Participants in the manual group used a printed manual and made a phone call for assistance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the overall score of the procedure
a 100-point scale converted from the original score. The participants scored 1 point for each step if they successfully finished the step within five minutes and obtained a maximum score of 35.
Measured: 30 minutes
Secondary outcomes (1)
the required level of assistance
The number of steps needed assistance to complete the procedure
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start24 Jan 2022
- Primary completion28 Jan 2022
- Study completion28 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nursing EducationStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meong Hi Son, Samsung Medical Center
- Investigators
- Meong Hi Son, MD, Principal investigator, Department of Pediatrics Samsung Medical Center and Sungkyunkwan University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446896
- Sponsor's protocol ID
- 2021-12-112-001
- Acronym
- AR
- Status last verified
- Jun 2022
- First submitted
- 25 Jun 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heo S, Moon S, Kim M, Park M, Cha WC, Son MH. An Augmented Reality-Based Guide for Mechanical Ventilator Setup: Prospective Randomized Pilot Trial. JMIR Serious Games. 2022 Jul 22;10(3):e38433. doi: 10.2196/38433.
PubMed 35867382
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Setting-up Of A Mechanical Ventilator With An Augmented Reality Guide: A Prospective, Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT05446896
- Acronym / sponsor ID
- AR / 2021-12-112-001
- Conditions
- Nursing Education
- Keywords
- Ventilator, Nursing, Education, Augmented reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to determine the feasibility and effectiveness of an augmented reality (AR)-based self-learning platform for novices to set up a ventilator without on-site assistance. This was a prospective randomized controlled pilot study conducted at Samsung Medical Center, Korea from January to February 2022. Nurses with no prior experience of MV or AR were enrolled. We randomized the participants into two groups: manual and AR groups. Participants in the manual group used a printed manual and made a phone call for assistance, whereas participants in the AR group were guided by AR-based instructions and requested assistance with the head-mounted device (HMD). We compared the overall score of the procedure, required level of assistance, and user's experience between the groups.
Detailed description
Background: Recently, the demand for mechanical ventilation (MV) has increased with the COVID-19 pandemic; however, the conventional approaches to MV training are resource-intensive and require on-site training. Consequently, the need for independent learning platforms with remote assistance in institutions without resources has surged.
Objective:
This study aimed to determine the feasibility and effectiveness of an augmented reality (AR)-based self-learning platform for novices to set up a ventilator without on-site assistance.
Method:
This was a prospective randomized controlled pilot study conducted at Samsung Medical Center, Korea from January to February 2022. Nurses with no prior experience of MV or AR were enrolled. We randomized the participants into two groups: manual and AR groups. Participants in the manual group used a printed manual and made a phone call for assistance, whereas participants in the AR group were guided by AR-based instructions and requested assistance with the head-mounted device (HMD). We compared the overall score of the procedure, required level of assistance, and user's experience between the groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AR group | Experimental | Device: AR guidance with Hololens 2participants in the AR group were guided by AR-based instructions and requested assistance with the head-mounted device. |
| manual group | No intervention | –Participants in the manual group used a printed manual and made a phone call for assistance. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- We enrolled nurses who had no prior experience with ventilator setup or AR systems, regardless of their work department or age.
Key exclusion criteria (1 listed)
- We excluded nurses who had already experienced setting up a ventilator or who had trouble wearing or using a head-mounted device (HMD).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AR guidance with Hololens 2The AR instructions were developed as a step-by-step guide with the same text and images as in the printed manual, utilizing the dynamic 365 Guide (Software, Microsoft Corporation, Redmond, WA, USA). The AR instructions were delivered using the Microsoft HoloLens 2. | Device | AR group |
Primary outcome
the overall score of the procedure
Time frame: 30 minutes
a 100-point scale converted from the original score. The participants scored 1 point for each step if they successfully finished the step within five minutes and obtained a maximum score of 35.
1 secondary outcome
the required level of assistance
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Derived from this study: PubMed 35867382Heo S, Moon S, Kim M, Park M, Cha WC, Son MH. An Augmented Reality-Based Guide for Mechanical Ventilator Setup: Prospective Randomized Pilot Trial. JMIR Serious Games. 2022 Jul 22;10(3):e38433. doi: 10.2196/38433.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meong Hi Son, MD principal investigator
Department of Pediatrics Samsung Medical Center and Sungkyunkwan University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AR guidance with Hololens 2 in people with Nursing Education, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the overall score of the procedure (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05446896, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.