TelemedicineNCT06171828
Tele-education in Ultrasound Training
A study testing Head-Mounted Display (HMD) to communicate with a supervisor remotely in people with Telemedicine and Ultrasonography, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The study aims to assess the impact of remote guidance in ultrasound training for medical professionals new to abdominal ultrasound. It involves 40 participants, divided into two groups of 20 each - a self-study group and a remote learning group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Telemedicine, Ultrasonography, Education, Medical, Continuing
- What is being tested?
- Head-Mounted Display (HMD) to communicate with a supervisor remotely
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Nov 2023to 14 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Licensed doctor
- Participants who didn't receive prior training in abdominal ultrasound
- > 18 years old
Who cannot join
- Individuals who do not agree to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Tele-education in Ultrasound Training: a Randomized, Controlled Pilot Study
The study aims to assess the impact of remote guidance in ultrasound training for medical professionals new to abdominal ultrasound. It involves 40 participants, divided into two groups of 20 each - a self-study group and a remote learning group. Participants include licensed doctors with no prior training in abdominal ultrasound, who are over 18 years old and have consented to participate.
Read the detailed description
The study's design includes pre-surveys, random assignment, ultrasound training through educational videos, and distinct practice methods for each group - one with remote guidance and the other with traditional, in-person assistance. The effectiveness of training will be evaluated based on scores from evaluation forms, time taken for ultrasound imaging, frequency of requesting help, and surveys (NASA-Task Load Index, System Usability Scale, and a Self-confidence pre/post survey). Statistical analysis will be conducted using R software, employing tests such as the student t-test or Wilcoxon rank sum test.
This research is anticipated to provide valuable insights into the efficacy of remote guidance in ultrasound education, potentially influencing future medical training methodologies.
- Being tested
- Head-Mounted Display (HMD) to communicate with a supervisor remotely
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head-Mounted Display (HMD) to communicate with a supervisor remotelyDevice
Participants in the experimental group are oriented on using the education platform and communicating with the supervisor through an HMD for about 5 minutes. They then perform and save their ultrasound imaging. If they require assistance, they request help verbally through the HMD's communication system. The supervisor remotely observes and immediately assists upon request, utilizing the HMD and a 360-degree camera.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Traditional Training) | No intervention | This arm of the study involves participants who will engage in a traditional learning process. After an initial pre-survey, they will start the ultrasound training phase. During this phase, participants will utilize pre-made educational videos for learning. Then participants will perform an ultrasound on an abdominal ultrasound phantom using a handout based on the pre-made video. When assistance is needed, participants will physically move to a different location to seek help from a supervisor. This face-to-face interaction allows for direct guidance and feedback. After completing the training sessions, participants will take a post-survey, which includes NASA-TLX, System Usability Scale (SUS), and a self-confidence assessment, to evaluate the training experience and measure the perceived workload, system usability, and confidence level changes due to the training. |
| Experimental Group (Remote Training) | Experimental | In this arm, participants will undergo a remote learning process. Similar to the control group, they begin with a pre-survey followed by the training phase using the same educational videos. Participants view a handout on a head-mounted display(HMD) and perform an ultrasound on an abdominal ultrasound phantom. The key difference is that when they require assistance, they will use a HMD to communicate with a supervisor remotely. This allows the supervisor to provide guidance without being physically present, utilizing the HMD and potentially other remote communication tools for real-time interaction. The training phase is intended to mimic the in-person guidance as closely as possible through technological means. Following the training, the participants will also complete the same post-survey as the control group to assess the impact of remote training on their learning experience. Receives: Device: Head-Mounted Display (HMD) to communicate with a supervisor remotely |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound Skill Evaluation Scale
The composite scores from the evaluation forms will serve as the primary measure of effectiveness. These scores will be based on a standardized evaluation scale titled "Ultrasound Skill Evaluation Scale", which ranges from 0 to 90 points, where higher scores indicate better performance. Scores will be analyzed and compared using statistical tests such as the Student's t-test or the Wilcoxon rank-sum test to evaluate skill acquisition differences between groups.
Measured: During the education session, approximately 30 minutes
Secondary outcomes (2)
Ultrasound Imaging Duration
The time taken by participants from the moment they pick up the probe to begin the first image until they press the 'End Exam' button to save the final ultrasound image will be recorded and analyzed. This measure assesses efficiency and speed of learning, with comparison between groups using the Student's t-test or Wilcoxon rank-sum test.
Measured: During the education session, approximately 30 minutes
Number of Assistance Requests
The frequency with which participants request help from the supervisor will also be tracked. This measure will help to understand the level of independence and confidence during the ultrasound procedure, as well as to determine if the time taken for the task is affected by these requests.
Measured: During the education session, approximately 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start15 Nov 2023
- Primary completion14 Dec 2023
- Study completion14 Dec 2023
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 TelemedicineStudies 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
- Interventional Clinical Trial, Parallel Assignment
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meonghi Son, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171828
- Sponsor's protocol ID
- 2023-10-015-003
- Status last verified
- Nov 2023
- First submitted
- 15 Nov 2023
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet decided
Publications
Kim M, Son MH, Moon S, Cha WC, Jo IJ, Yoon H. A Mixed Reality-Based Telesupervised Ultrasound Education Platform on 5G Network Compared to Direct Supervision: Prospective Randomized Pilot Trial. JMIR Serious Games. 2025 Jan 16;13:e63448. doi: 10.2196/63448.
PubMed 39819654
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Tele-education in Ultrasound Training: a Randomized, Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT06171828
- Acronym / sponsor ID
- 2023-10-015-003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 14 Dec 2023 (actual)
- First posted
- 15 Dec 2023 (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 study aims to assess the impact of remote guidance in ultrasound training for medical professionals new to abdominal ultrasound. It involves 40 participants, divided into two groups of 20 each - a self-study group and a remote learning group. Participants include licensed doctors with no prior training in abdominal ultrasound, who are over 18 years old and have consented to participate.
Detailed description
The study's design includes pre-surveys, random assignment, ultrasound training through educational videos, and distinct practice methods for each group - one with remote guidance and the other with traditional, in-person assistance. The effectiveness of training will be evaluated based on scores from evaluation forms, time taken for ultrasound imaging, frequency of requesting help, and surveys (NASA-Task Load Index, System Usability Scale, and a Self-confidence pre/post survey). Statistical analysis will be conducted using R software, employing tests such as the student t-test or Wilcoxon rank sum test.
This research is anticipated to provide valuable insights into the efficacy of remote guidance in ultrasound education, potentially influencing future medical training methodologies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Interventional Clinical Trial, Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Control Group (Traditional Training) | No intervention | –This arm of the study involves participants who will engage in a traditional learning process. After an initial pre-survey, they will start the ultrasound training phase. During this phase, participants will utilize pre-made educational videos for learning. Then participants will perform an ultrasound on an abdominal ultrasound phantom using a handout based on the pre-made video. When assistance is needed, participants will physically move to a different location to seek help from a supervisor. This face-to-face interaction allows for direct guidance and feedback. After completing the training sessions, participants will take a post-survey, which includes NASA-TLX, System Usability Scale (SUS), and a self-confidence assessment, to evaluate the training experience and measure the perceived workload, system usability, and confidence level changes due to the training. |
| Experimental Group (Remote Training) | Experimental | Device: Head-Mounted Display (HMD) to communicate with a supervisor remotelyIn this arm, participants will undergo a remote learning process. Similar to the control group, they begin with a pre-survey followed by the training phase using the same educational videos. Participants view a handout on a head-mounted display(HMD) and perform an ultrasound on an abdominal ultrasound phantom. The key difference is that when they require assistance, they will use a HMD to communicate with a supervisor remotely. This allows the supervisor to provide guidance without being physically present, utilizing the HMD and potentially other remote communication tools for real-time interaction. The training phase is intended to mimic the in-person guidance as closely as possible through technological means. Following the training, the participants will also complete the same post-survey as the control group to assess the impact of remote training on their learning experience. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Licensed doctor
- Participants who didn't receive prior training in abdominal ultrasound
- > 18 years old
Key exclusion criteria (1 listed)
- Individuals who do not agree to participate in the study
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 |
|---|---|---|
| Head-Mounted Display (HMD) to communicate with a supervisor remotelyParticipants in the experimental group are oriented on using the education platform and communicating with the supervisor through an HMD for about 5 minutes. They then perform and save their ultrasound imaging. If they require assistance, they request help verbally through the HMD's communication system. The supervisor remotely observes and immediately assists upon request, utilizing the HMD and a 360-degree camera. | Device | Experimental Group (Remote Training) |
Primary outcome
Ultrasound Skill Evaluation Scale
Time frame: During the education session, approximately 30 minutes
The composite scores from the evaluation forms will serve as the primary measure of effectiveness. These scores will be based on a standardized evaluation scale titled "Ultrasound Skill Evaluation Scale", which ranges from 0 to 90 points, where higher scores indicate better performance. Scores will be analyzed and compared using statistical tests such as the Student's t-test or the Wilcoxon rank-sum test to evaluate skill acquisition differences between groups.
2 secondary outcomes
Ultrasound Imaging Duration
Time frame: During the education session, approximately 30 minutes
Number of Assistance Requests
Time frame: During the education session, approximately 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 3 Jan 2025.
- Derived from this study: PubMed 39819654Kim M, Son MH, Moon S, Cha WC, Jo IJ, Yoon H. A Mixed Reality-Based Telesupervised Ultrasound Education Platform on 5G Network Compared to Direct Supervision: Prospective Randomized Pilot Trial. JMIR Serious Games. 2025 Jan 16;13:e63448. doi: 10.2196/63448.
- Individual participant dataSharing planned: Undecided. Not yet decided
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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.
Meonghi Son, MD principal investigator
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 Head-Mounted Display (HMD) to communicate with a supervisor remotely in people with Telemedicine and Ultrasonography, 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 3 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 3 Jan 2025. 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?
Ultrasound Skill Evaluation Scale (time frame: During the education session, approximately 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 NCT06171828, 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 3 Jan 2025.