<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03280199</url>
  </required_header>
  <id_info>
    <org_study_id>2017-09-GCMT</org_study_id>
    <nct_id>NCT03280199</nct_id>
  </id_info>
  <brief_title>The Impact of Different Simulator Characteristics on Transfer of Learning</brief_title>
  <official_title>The Impact of Different Simulator Characteristics on Transfer of Learning</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to explore the impact of different simulator characteristics on transfer of&#xD;
      learning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During an ISUOG basic training course, participants will be randomly assigned to 30 minutes&#xD;
      of simulator training during which time they will practice the 2nd trimester US scan. A total&#xD;
      of four different simulators are being used for training. After completing the practical&#xD;
      basic training session, they shift the type of simulator that they trained on to one of the&#xD;
      remaining three simulators. On this simulator, they are required to perform selected planes&#xD;
      for the 2nd-trimester scan. The planes produced are recorded and evaluated by fetal medicine&#xD;
      specialists using the ISUOG 20 planes checklist. The performances of participants coming from&#xD;
      each of the four simulators are examined and the role of 1) type of simulator interaction&#xD;
      (physical mannequin vs. virtual abdomen vs. fixed-point scan) and 2) the type of image&#xD;
      acquisition (real US images vs. computer-generated images) are examined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correct planes</measure>
    <time_frame>30 minutes</time_frame>
    <description>Number of correct planes produced</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Simulation-based Medical Education</condition>
  <condition>Ultrasound Simulation</condition>
  <condition>Education, Professional</condition>
  <arm_group>
    <arm_group_label>Type of simulator - 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>VR simulator with physical mannequin and probe.&#xD;
PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG!</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type of simulator - 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>VR simulator with virtual mannequin / abdomen&#xD;
PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG!</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type of image acquisition - 3</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>US images are acquired through real US volumes from patients&#xD;
PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG!</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type of image acquisition - 4</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>US images are acquired through computer-generated images.&#xD;
PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG!</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>simulation types</intervention_name>
    <description>Different types of simulation interfaces and image acquisitions</description>
    <arm_group_label>Type of image acquisition - 3</arm_group_label>
    <arm_group_label>Type of image acquisition - 4</arm_group_label>
    <arm_group_label>Type of simulator - 1</arm_group_label>
    <arm_group_label>Type of simulator - 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ISUOG course participants&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        More than 50 independent 2nd trimester US scan before attending the course.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Martin G. Tolsgaard</investigator_full_name>
    <investigator_title>MD PhD, assistant professor.</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03280199
org study id: 2017-09-GCMT
nct id: NCT03280199
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to explore the impact of different simulator characteristics on transfer of
      learning.
During an ISUOG basic training course, participants will be randomly assigned to 30 minutes
      of simulator training during which time they will practice the 2nd trimester US scan. A total
      of four different simulators are being used for training. After completing the practical
      basic training session, they shift the type of simulator that they trained on to one of the
      remaining three simulators. On this simulator, they are required to perform selected planes
      for the 2nd-trimester scan. The planes produced are recorded and evaluated by fetal medicine
      specialists using the ISUOG 20 planes checklist. The performances of participants coming from
      each of the four simulators are examined and the role of 1) type of simulator interaction
      (physical mannequin vs. virtual abdomen vs. fixed-point scan) and 2) the type of image
      acquisition (real US images vs. computer-generated images) are examined.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Correct planes
time frame: 30 minutes
description: Number of correct planes produced
arm group label: Type of simulator - 1
arm group type: Other
description: VR simulator with physical mannequin and probe.
PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG!
arm group label: Type of simulator - 2
arm group type: Other
description: VR simulator with virtual mannequin / abdomen
PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG!
arm group label: Type of image acquisition - 3
arm group type: Other
description: US images are acquired through real US volumes from patients
PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG!
arm group label: Type of image acquisition - 4
arm group type: Other
description: US images are acquired through computer-generated images.
PLEASE NOTE THAT THE INTERVENTIONS BEING COMPARED ARE DIFFERENT TYPES OF SIMULATORS - NOT A DRUG!
intervention type: Other
intervention name: simulation types
description: Different types of simulation interfaces and image acquisitions
arm group label: Type of image acquisition - 3
arm group label: Type of image acquisition - 4
arm group label: Type of simulator - 1
arm group label: Type of simulator - 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Martin G. Tolsgaard
investigator title: MD PhD, assistant professor.
sharing ipd: No