- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05834374
Training for Transfer by Contextual Variation
Training for Transfer by Contextual Variation: A Randomized Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants:
Participants are medical student from the University of Copenhagen. They are recruited by announcements on student fora on Facebook.
Randomization:
The participants are randomized to the intervention group contextual variation, the intervention group maximum affordances or control group minimum affordances in an 1:1:1 allocation ratio. In addition, the order of the four transfer tests (a, b, c and d) is randomly selected for each participant. The randomization was conducted by an independent research assistant at CAMES. Random permuted blocks are generated online for both the intervention and the transfer test.
Equiptment:
The training session is conducted on a ballistic gel cube. Three cavities are excavated corresponding to the points of a triangle at the bottom of the cube. Each cavity include a 5" latex balloon filled with 10ml water. The ballistic gel is coloured with graphite thus, the cavities can only be visualized by ultrasound. The participants are instructed to perform ultrasound guided needle puncture of the cavities using a 20 ml syringe and a 15 cm, 18 Gauge biopsy needle. When all the three cavities are emptied the participant receive a new cube with refilled balloons. The new cube is equivalent to the old apart from being rotated 180 degrees. The participant are given one hour to empty as many cavities as possible. They are encouraged to track the needle with ultrasound while in the cube. The transfer test is performed on a CVS mannikin. The GE HealthCare LOGIQTM e Ultrasound is used with a C1-5 RS probe with or without the GE HealthCare C1-5 non-sterile ultrasound needle guide for both the training session and the transfer tests.
Intervention:
In the first learning session the participants are provided with an ultrasound probe and a needle and instructed to detect and aim at a fixed target in a cube made of ballistic gel. The contextual variation group alternate between six affordance conditions where the surface of the model i either half covered combined with no guide, a partial guide or a complete guide. The maximum affordances group has half the surface model covered and a complete guide throughout the session. The control group has the whole surface uncovered and no guide throughout the session. The participants will have 60 minutes to complete the training.
Transfer test:
The groups are re-invited seven days after completed training for a transfer test. The transfer test include four cases (a, b, c, d) where the overall aim is to perform a CVS procedure on a CVS mannikin. In case a and b, the participant has the affordances of a guide on the ultrasound probe and the screen. In case c and d, there is a lack of affordances by not using a guide on the probe or screen. The placental position is anterior in case a and c, and posterior in case b and d. The transfer test measures both the transfer out, i.e. applying a skill learned in one context to a new context, and transfer in, how the learner learns with the acquired skills in the new context. The order of the transfer tests is randomized at inclusion. The participants receive a brief introduction to the chorionic villus sampling (CVS) procedure ahead of the transfer test by watching a video where the procedure is performed in a clinical setting.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark
- Copenhagen Academy of Medical Education and Simulation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Passed a general anatomy exam
- Proficiency in Danish
Exclusion Criteria:
- Previous ultrasound experience except mandatory training as part of the medical curriculum
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Contextual variation
The contextual variation group alternate between six affordance conditions where the surface of the model i either half covered combined with no guide, a partial guide or a complete guide.
|
The participants are instructed to perform ultrasound guided needle puncture of the cavities using a 20 ml syringe and a 15 cm, 18 Gauge biopsy needle.
When all the three cavities are emptied the participant receive a new cube with refilled balloons.
The new cube is equivalent to the old apart from being rotated 180 degrees.
The participant are given one hour to empty as many cavities as possible.
They are encouraged to track the needle with ultrasound while in the cube.
The transfer test is performed on a CVS mannikin.
The GE HealthCare LOGIQTM e Ultrasound is used with a C1-5 RS probe with or without the GE HealthCare C1-5 non-sterile ultrasound needle guide for both the training session and the transfer tests.
Other Names:
|
Experimental: Maximum affordances
The maximum affordances group has half the surface model covered and a complete guide throughout the session.
|
The participants are instructed to perform ultrasound guided needle puncture of the cavities using a 20 ml syringe and a 15 cm, 18 Gauge biopsy needle.
When all the three cavities are emptied the participant receive a new cube with refilled balloons.
The new cube is equivalent to the old apart from being rotated 180 degrees.
The participant are given one hour to empty as many cavities as possible.
They are encouraged to track the needle with ultrasound while in the cube.
The transfer test is performed on a CVS mannikin.
The GE HealthCare LOGIQTM e Ultrasound is used with a C1-5 RS probe with or without the GE HealthCare C1-5 non-sterile ultrasound needle guide for both the training session and the transfer tests.
|
No Intervention: Minimum affordances
The control group has the whole surface uncovered and no guide throughout the session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Transfertest score
Time Frame: 4*7 min (4 tests) 7-10 days after intervention
|
Exåpert based performances scores using a 5 point likert scale rating 4 items.
Higher scores indicate better performance.
|
4*7 min (4 tests) 7-10 days after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Training
Time Frame: 60 min (training session)
|
Quantitative analysis of use of movements (many movements indicate expert performance), number of emptied ballons (higher number indicates better perfomance), incisions/ballon (lower number indicates better performance)
|
60 min (training session)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Martin G Tolsgaard, Professor, Rigshospitalet, Denmark
- Principal Investigator: Vilma L Johnsson, M.D., Rigshospitalet, Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H-19039518
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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