Equipment and SuppliesNCT06506851
Effects of Augmented Reality-based Rapid Blood Transfusion (Level-1®)
A study testing AR-based Training with Microsoft HoloLens 2® and Traditional Guideline-based Self-Learning in people with Equipment and Supplies and Augmented Reality, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to compare the effectiveness of AR-based training with traditional guideline-based self-learning in practical nurses without prior Level-1® experience. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Equipment and Supplies, Augmented Reality, Nurse's Role
- What is being tested?
- AR-based Training with Microsoft HoloLens 2® and Traditional Guideline-based Self-Learning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jul 2023to 5 Sep 2023
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Willingness to participate voluntarily and understanding of the study's purpose.
- No prior experience with the Level-1® rapid infusion system.
Who cannot join
- Failure to meet the inclusion criteria.
- Prior experience with the Level-1® rapid infusion system.
- Inability to comprehend the study's purpose or express voluntary participation.
- Inability to attend required training and evaluations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Augmented Reality-based Rapid Blood Transfusion (Level-1®) Education on Nurse's Clinical Competency, Self-efficacy, and Educational Satisfaction: Randomised Controlled Trial
The goal of this clinical trial is to compare the effectiveness of AR-based training with traditional guideline-based self-learning in practical nurses without prior Level-1® experience. The main questions it aims to answer are:
Does AR-based training using Microsoft HoloLens 2® improve clinical performance compared to traditional guideline-based self-learning? Does AR-based training affect self-efficacy and educational satisfaction compared to traditional methods?
Read more
Participants will:
Receive AR-based training using Microsoft HoloLens 2® (experimental group) Follow traditional guideline-based self-learning (control group) Researchers will compare the AR-based training group to the traditional self-learning group to see if AR-based training leads to better clinical performance, higher self-efficacy, and greater educational satisfaction.
Read the detailed description
In critical situations like hypovolemic shock, nurses must master skills for using devices like the Level-1® rapid infusion system. However, limited exposure poses challenges. Augmented reality (AR) offers a solution by providing realistic practice scenarios. While AR has shown effectiveness in cardiopulmonary resuscitation and intubation education, its application in Level-1® training remains underexplored.
This study was conducted at the Samsung Medical Center in Seoul, Korea, and involved 42 practical nurses without prior Level-1® experience. Participants were randomly assigned to one of two groups: the experimental group, which received AR-based training using Microsoft HoloLens 2®, and the control group, which followed traditional guideline-based self-learning.
The study aimed to investigate the impact of AR-based Level-1® education on nurses' clinical performance, self-efficacy, and educational satisfaction. Clinical performance, self-efficacy, and educational satisfaction were assessed through structured measurements.
Results data and conclusions drawn from the data are excluded from this section and will be reported separately in the Results Section of the record.
- Conditions
- Equipment and Supplies, Augmented Reality, Nurse's Role
- Being tested
- AR-based Training with Microsoft HoloLens 2®, Traditional Guideline-based Self-Learning
- Keywords
- Augmented Reality, Education, Nursing, Blood Transfusion, Self-efficacy, Educational Satisfaction, Clinical Competency, Critical Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR-based Training with Microsoft HoloLens 2®Other
Practical nurses in this group receive AR-based training using Microsoft HoloLens 2®. This training method incorporates augmented reality technology to provide immersive and interactive learning experiences, enhancing their proficiency in device utilization.
Traditional Guideline-based Self-LearningOther
Practical nurses in this group follow traditional guideline-based self-learning methods without augmented reality technology. They rely on conventional educational materials and guidelines for learning device utilization skills.
| Study group | Role | What they receive |
|---|---|---|
| AR-based Training Group | Experimental | Practical nurses in this arm receive AR-based training using Microsoft HoloLens 2®. This training method incorporates augmented reality technology to provide immersive and interactive learning experiences, enhancing their proficiency in device utilization. Receives: Other: AR-based Training with Microsoft HoloLens 2® |
| Traditional Self-Learning Group | Sham comparator | Practical nurses in this arm follow traditional guideline-based self-learning methods without augmented reality technology. They rely on conventional educational materials and guidelines for learning device utilization skills. Receives: Other: Traditional Guideline-based Self-Learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Competency
This measurement assesses nurses' clinical competency in rapid infusion procedures. It includes evaluation of learning time, performance time, accuracy, and assistance requests.
Measured: before training, immediately after training
Secondary outcomes (1)
Self-efficacy
This assessment measures nurses' self-efficacy in rapid infusion procedures using a modified self-efficacy scale. It evaluates confidence levels in performing tasks related to rapid infusion.
Measured: efore training, immediately after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start17 Jul 2023
- Primary completion5 Sep 2023
- Study completion5 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Equipment and SuppliesStudies 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
- Model description
- Experimental Group (AR-based Training): Nurses receive AR-based training with Microsoft HoloLens 2®, immersing them in interactive simulations for hands-on learning. Control Group (Traditional Self-Learning): Nurses follow traditional guideline-based self-learning methods without augmented reality technology.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- meonghi son, MD, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506851
- Sponsor's protocol ID
- 2023-06-084
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Augmented Reality-based Rapid Blood Transfusion (Level-1®) Education on Nurse's Clinical Competency, Self-efficacy, and Educational Satisfaction: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06506851
- Acronym / sponsor ID
- 2023-06-084
- Conditions
- Equipment and Supplies, Augmented Reality, Nurse's Role
- Keywords
- Augmented Reality, Education, Nursing, Blood Transfusion, Self-efficacy, Educational Satisfaction, Clinical Competency, Critical Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 18 Jul 2024 (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.
The goal of this clinical trial is to compare the effectiveness of AR-based training with traditional guideline-based self-learning in practical nurses without prior Level-1® experience. The main questions it aims to answer are:
Does AR-based training using Microsoft HoloLens 2® improve clinical performance compared to traditional guideline-based self-learning? Does AR-based training affect self-efficacy and educational satisfaction compared to traditional methods?
Participants will:
Receive AR-based training using Microsoft HoloLens 2® (experimental group) Follow traditional guideline-based self-learning (control group) Researchers will compare the AR-based training group to the traditional self-learning group to see if AR-based training leads to better clinical performance, higher self-efficacy, and greater educational satisfaction.
Detailed description
In critical situations like hypovolemic shock, nurses must master skills for using devices like the Level-1® rapid infusion system. However, limited exposure poses challenges. Augmented reality (AR) offers a solution by providing realistic practice scenarios. While AR has shown effectiveness in cardiopulmonary resuscitation and intubation education, its application in Level-1® training remains underexplored.
This study was conducted at the Samsung Medical Center in Seoul, Korea, and involved 42 practical nurses without prior Level-1® experience. Participants were randomly assigned to one of two groups: the experimental group, which received AR-based training using Microsoft HoloLens 2®, and the control group, which followed traditional guideline-based self-learning.
The study aimed to investigate the impact of AR-based Level-1® education on nurses' clinical performance, self-efficacy, and educational satisfaction. Clinical performance, self-efficacy, and educational satisfaction were assessed through structured measurements.
Results data and conclusions drawn from the data are excluded from this section and will be reported separately in the Results Section of the record.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental Group (AR-based Training): Nurses receive AR-based training with Microsoft HoloLens 2®, immersing them in interactive simulations for hands-on learning. Control Group (Traditional Self-Learning): Nurses follow traditional guideline-based self-learning methods without augmented reality technology.
| Arm | Type | Receives |
|---|---|---|
| AR-based Training Group | Experimental | Other: AR-based Training with Microsoft HoloLens 2®Practical nurses in this arm receive AR-based training using Microsoft HoloLens 2®. This training method incorporates augmented reality technology to provide immersive and interactive learning experiences, enhancing their proficiency in device utilization. |
| Traditional Self-Learning Group | Sham comparator | Other: Traditional Guideline-based Self-LearningPractical nurses in this arm follow traditional guideline-based self-learning methods without augmented reality technology. They rely on conventional educational materials and guidelines for learning device utilization skills. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Willingness to participate voluntarily and understanding of the study's purpose.
- No prior experience with the Level-1® rapid infusion system.
Key exclusion criteria (4 listed)
- Failure to meet the inclusion criteria.
- Prior experience with the Level-1® rapid infusion system.
- Inability to comprehend the study's purpose or express voluntary participation.
- Inability to attend required training and evaluations.
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-based Training with Microsoft HoloLens 2®Practical nurses in this group receive AR-based training using Microsoft HoloLens 2®. This training method incorporates augmented reality technology to provide immersive and interactive learning experiences, enhancing their proficiency in device utilization. | Other | AR-based Training Group |
| Traditional Guideline-based Self-LearningPractical nurses in this group follow traditional guideline-based self-learning methods without augmented reality technology. They rely on conventional educational materials and guidelines for learning device utilization skills. | Other | Traditional Self-Learning Group |
Primary outcome
Clinical Competency
Time frame: before training, immediately after training
This measurement assesses nurses' clinical competency in rapid infusion procedures. It includes evaluation of learning time, performance time, accuracy, and assistance requests.
1 secondary outcome
Self-efficacy
Time frame: efore training, immediately after training
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 18 Jul 2024.
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Equipment and Supplies
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.
meonghi son, MD study chair
Samsung Medical Center
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-based Training with Microsoft HoloLens 2® and Traditional Guideline-based Self-Learning in people with Equipment and Supplies and Augmented Reality, 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 2 inclusion and 4 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 18 Jul 2024. 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. Some participants in this study may receive a placebo. 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?
Clinical Competency (time frame: before training, immediately after training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2024.