Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05834374 |
Other study ID # |
H-19039518 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 17, 2021 |
Est. completion date |
October 7, 2021 |
Study information
Verified date |
April 2023 |
Source |
Rigshospitalet, Denmark |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The goal of this randomized study is to investigate the effect of introducing contextual
variation on transfer when learning a technical skill in a group of medical students. The
main questions it aims to answer is: If context variation of specific affordance conditions
enhance the learner's ability to transfer out? Participants will practice performing an
invasive ultrasound guided procedure either on a fantom with maximum affordances or with
contextual variation. Researchers will compare the maximum affordances group and the
contextual variation group to see if its effects compared to the control group with minimal
affordances.
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.