ClinicalTrials.gg
CompletedNCT06171828Updated Jan 3, 2025

Tele-education in Ultrasound Training

An interventional study of Head-Mounted Display (HMD) to communicate with a supervisor remotely in Telemedicine, Ultrasonography and Education, Medical, Continuing, sponsored by Samsung Medical Center. Completed at 1 site in South Korea. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-03.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Telemedicine
  • Ultrasonography
  • Education, Medical, Continuing
03

In context

Lead sponsor

Samsung Medical Center is the lead sponsor of 1,005 studies on the registry; 148 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Licensed doctor
  • Participants who didn't receive prior training in abdominal ultrasound
  • > 18 years old

Exclusion criteria

Exclusion Criteria:

- Individuals who do not agree to participate in the study

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
40 participants (actual)

Study arms

  • No intervention
    Control Group (Traditional Training)

    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
    Experimental Group (Remote Training)

    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.

    Device: Head-Mounted Display (HMD) to communicate with a supervisor remotely

Interventions

  • DeviceHead-Mounted Display (HMD) to communicate with a supervisor remotely

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: During the education session, approximately 30 minutes

Secondary outcomes

  1. 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.

    Time frame: During the education session, approximately 30 minutes

  2. 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.

    Time frame: During the education session, approximately 30 minutes

Other outcomes

  1. NASA-Task Load Index (TLX)

    The NASA Task Load Index (NASA-TLX) survey will be used to compare the perceived workload between participants seeking physical assistance and those receiving remote guidance through head-mounted displays (HMDs). Six aspects of workload will be assessed: mental demand, physical demand, temporal demand, performance, effort, and frustration. Scores range from 0 (lowest workload) to 100 (highest workload).

    Time frame: After the training (Traditional and HMD), approximately 1hr

  2. System Usability Scale (SUS)

    Participants will complete the System Usability Scale (SUS) survey based on their experience with the abdominal ultrasound training. The SUS score measures system usability on a scale ranging from 0 to 100, with higher scores indicating better usability. The scores will be calculated according to the standard scoring system.

    Time frame: After the training (Traditional and HMD), approximately 1hr

  3. Confidence Assessment

    Pre- and post-training surveys will assess participants' confidence in identifying abdominal organs using ultrasound. Confidence will be rated on a Likert scale from 1 (not confident at all) to 5 (extremely confident). Changes in self-perceived competence before and after training will be analyzed.

    Time frame: After the training (Traditional and HMD), approximately 1hr

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, Seoul 06351, South Korea
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided — Not yet decided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06171828
Responsible party
Sponsor
First posted
Dec 15, 2023
Start date
Nov 15, 2023
Primary completion
Dec 14, 2023
Completion
Dec 14, 2023
Last update
Jan 3, 2025

Study contacts

Meonghi Son, MD
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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