Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
110 participants
INTERVENTIONAL
2021-03-17
2021-10-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Contextual variation
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.
Maximum affordances
The maximum affordances group has half the surface model covered and a complete guide throughout the session.
Maximum affordances
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.
Minimum affordances
The control group has the whole surface uncovered and no guide throughout the session.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Contextual variation
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.
Maximum affordances
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Proficiency in Danish
Exclusion Criteria
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rigshospitalet, Denmark
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Vilma Johnsson
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Martin G Tolsgaard, Professor
Role: STUDY_CHAIR
Rigshospitalet, Denmark
Vilma L Johnsson, M.D.
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Copenhagen Academy of Medical Education and Simulation
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-19039518
Identifier Type: -
Identifier Source: org_study_id