- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05874609
Teaching Neuraxial Ultrasonography With a Virtual Reality Simulator of Spine
May 24, 2023 updated by: Cui Xulei, Peking Union Medical College Hospital
Teaching Neuraxial Ultrasonography With a Virtual Reality Simulator of Spine: a Randomized Controlled Trial
As one of the most extensively practiced regional block, neuraxial anesthesia is the basic skill for anesthesiologist to acquire.
Recently, virtual reality (VR) has been proposed as a new simulation training method to enhance medical education.
The aim of our study is to evaluate the practical skills of ultrasound scan and the satisfaction of students who undergo training using VR versus traditional didactic lecture.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a prospective, single-center, randomized control trial to evaluate the performance of spine ultrasound scan after different training methods.
Participants were randomly divided into two groups receiving different training methods: VR spine simulator or traditional didactic teaching.
After the training, participants were required to perform a preprocedural spine ultrasound scan on healthy volunteers using the stepwise technique taught in the didactic teaching session.
The participants needed to acquire three key ultrasound views during the scan and recognize the anatomic structures in three ultrasound views.
Study Type
Interventional
Enrollment (Estimated)
46
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- anesthesia residents in our department
Exclusion Criteria:
- having previous experience of spine ultrasonography training
- having previous experience of spine ultrasound scan.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VR group
In the VR group, the participants spent 30 minutes with the VR spine simulator after receiving the didactic teaching session.
|
The participants spent 30 minutes with the VR spine simulator after receiving the didactic teaching session.
The learning objective with the VR simulator is to review the 3D lumbar spine anatomic model,learn the sonoanatomy presented by a dynamic ultrasound scan of the sagittal and transverse plane, and practice a preprocedural ultrasound scan.
|
|
Active Comparator: Control group
In the control group, the participants received a 30-min traditional didactic teaching session of spine ultrasonography.
|
A 30-min traditional didactic teaching session of spine ultrasonography.
This session was consisted of general spine anatomy, sonographic technique and sonoanatomy, description of five key spine ultrasonographic views (transverse spinous process view, transverse interlaminar view, parasagittal oblique interlaminar view, parasagittal articular process view, parasagittal transverse process view), and a stepwise technique of preprocedural lumbar spine scan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite learning score
Time Frame: Up to 12 hours after ultrasound scan is finished
|
Evaluating the self-assessed theoretical knowledge (10 points), self-assessed practical skills (20 points), self-assessed satisfaction (10 points) and willingness to applicate the technique in future practice (10 points).
|
Up to 12 hours after ultrasound scan is finished
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time of scan
Time Frame: Up to 1 hour after ultrasound scan begins
|
Defined as the time from the probe contacting the skin to acquiring the three key ultrasound views
|
Up to 1 hour after ultrasound scan begins
|
|
Rate of anatomic structures recognition
Time Frame: Up to 12 hours after ultrasound scan is finished
|
The correct rate of recognition among 12 anatomic structures (posterior complex, anterior complex, lamina and erector spinae in the parasagittal oblique interlaminar view, spinous process, lamina and erector spinae transverse spinous view, articular process, transverse process, posterior complex, anterior complex and spinal canal in the transverse interlaminar view)
|
Up to 12 hours after ultrasound scan is finished
|
|
Accuracy of depth measurement to the posterior complex
Time Frame: Up to 12 hours after ultrasound scan is finished
|
The measurement was deemed correct if the error was less than 0.5cm
|
Up to 12 hours after ultrasound scan is finished
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 15, 2023
Primary Completion (Estimated)
June 30, 2023
Study Completion (Estimated)
June 30, 2023
Study Registration Dates
First Submitted
May 5, 2023
First Submitted That Met QC Criteria
May 24, 2023
First Posted (Actual)
May 25, 2023
Study Record Updates
Last Update Posted (Actual)
May 25, 2023
Last Update Submitted That Met QC Criteria
May 24, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- VR teaching
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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