<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/NCT01703975</url>
  </required_header>
  <id_info>
    <org_study_id>DRVK-35596</org_study_id>
    <nct_id>NCT01703975</nct_id>
  </id_info>
  <brief_title>The Effects of Virtual Reality Ultrasound Training in Pairs Compared to Training Alone</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Copenhagen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Virtual Reality (VR) simulation has enabled high-quality, safe and efficient training of&#xD;
      medical health care providers. However, training costs are considerable and may be optimized&#xD;
      using interventions to improve learning. The aim of this study is to compare the effects of&#xD;
      training in pairs versus training alone on an VR ultrasound simulator.&#xD;
&#xD;
      Methods: 30 medical students in their final year are randomized to either training in pairs&#xD;
      or training alone. All participants are trained for two hours. Subsequently, all students are&#xD;
      assessed on ultrasound performance on real patients in an ambulatory setting. Performance is&#xD;
      assessed using a rating scale that has been validated in a previous study by two blinded&#xD;
      assessors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ultrasound is becoming increasingly used in many medical specialties. However, the quality of&#xD;
      the ultrasound examination is highly operator dependent and sufficient training of clinicians&#xD;
      is challenging. Virtual Reality ultrasound simulation enables training under controlled&#xD;
      conditions and it allows trainees to make mistakes before practicing on patients. However,&#xD;
      this type of training is expensive due to costs of simulators and clinician supervisors to&#xD;
      provide instructions and feedback while the trainees are practicing. Training in pairs, also&#xD;
      known as dyad training, may provide a learning advantage to trainees due to shared memory and&#xD;
      increased confidence. Moreover, dyad training allows training twice the number of trainees on&#xD;
      simulators, which has implications to the cost-effectiveness of VR simulation.&#xD;
&#xD;
      In this study, we examine non-inferiority of dyad training compared to the effect of&#xD;
      traditional training based on clinician instruction using a VR ultrasound simulator.&#xD;
&#xD;
      Methods Study design. A randomized observer-blinded non-inferiority study in which training&#xD;
      in pairs is compared to training alone on a VR simulator.&#xD;
&#xD;
      Pilot study. Two pilot studies were conducted to determine which modules to include in the&#xD;
      training curriculum and how to provide a standardized instruction of trainees. The first&#xD;
      pilot study included 10 OB/GYN residents and 10 OB/GYN consultants, who rated and commented&#xD;
      each module with regards to how useful they were to pelvic ultrasound training. These ratings&#xD;
      were used to develop a training curriculum consisting of a series of basic gynecologic&#xD;
      training modules. The second pilot study included 6 medical students, of which half trained&#xD;
      in pairs and the other half trained alone with clinician instructions. This enabled the&#xD;
      research team to develop a template for the instruction that should be provided by clinician&#xD;
      instructors in the group of participants that practiced alone.&#xD;
&#xD;
      Participants. Year-six medical students in their final rotations before entering residency&#xD;
      enrolled in this study. The only exclusion criterion was previous ultrasound courses or&#xD;
      extra-curricular ultrasound training. 30 participants were enrolled to ensure that at least&#xD;
      24 completed the transfer test.&#xD;
&#xD;
      Setting. All participants are trained on a VR ultrasound simulator (Scantrainer, Medaphor) in&#xD;
      an OB/GYN clerkship site. The Scantrainer is a high-fidelity vaginal ultrasound simulator&#xD;
      that provides haptic feedback and realistic imaging.&#xD;
&#xD;
      Randomization. All students were randomized to either training in pairs or training alone.&#xD;
      Randomization was conducted at a different clinical department using computer-generated list&#xD;
      of random numbers.&#xD;
&#xD;
      Intervention. All students received 30 minutes of introduction to the simulator including a&#xD;
      short introduction to vaginal ultrasound examination. The simulator instruction was provided&#xD;
      using a standardized template developed in the pilot study. Constructive feedback was&#xD;
      provided when participants encountered problems that they wanted feedback on. The instructor&#xD;
      was a clinician ultrasound simulation expert. The participants in the intervention group did&#xD;
      not receive any continuous instructor support but were allowed to consult an instructor&#xD;
      whenever the participants encountered a module that they could not pass. The total training&#xD;
      time was two hours in both groups. Hence, participants in the dyad group received half the&#xD;
      'hands-on' time as the participants in the control group.&#xD;
&#xD;
      Outcome measure. The outcome measure was ultrasound examination skills on pelvic ultrasound&#xD;
      examination of patients in an ambulatory setting. Participants were asked to perform a&#xD;
      systematic ultrasonic transvaginal examination including measurement of endometrial thickness&#xD;
      and estimate the volume of the right ovary. All patients were required to provide written&#xD;
      consent to participate. A blinded gynecologist rated performance using a previously validated&#xD;
      rating scale.&#xD;
&#xD;
      Sample size calculation. Based on a previous construct validation study, a difference in&#xD;
      performance scores corresponding to two months of clinical experience was regarded as&#xD;
      significant, which corresponded a 4.6% difference. Using a SD of 0.2, a power of 0.80 and an&#xD;
      alpha of 0.05, the total number of participants required was 24.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</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>Parallel Assignment</intervention_model>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Performance test</measure>
    <time_frame>6 hours</time_frame>
    <description>The outcome measure was ultrasound examination skills on pelvic ultrasound examination of patients in an ambulatory setting. Participants were asked to perform a systematic ultrasonic transvaginal examination including measurement of endometrial thickness and estimate the volume of the right ovary. All patients were required to provide written consent to participate. A blinded OB/GYN consultant rated performance using a previously validated rating scale.Sample size calculation and statistical methods.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Confidence</measure>
    <time_frame>6 hours</time_frame>
    <description>Students' confidence in managing the vaginal ultrasound examination are assessed after the post-intervention performance tests</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Learning Outcome</condition>
  <condition>Training Efficiency</condition>
  <arm_group>
    <arm_group_label>Single training</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Students training alone on the simulator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Training in pairs (Dyad Training)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Students training in pairs on the simulator</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Training in pairs (Dyad training)</intervention_name>
    <arm_group_label>Training in pairs (Dyad Training)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Final year medical students&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Prior extra-curricular ultrasound experience.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dept. of Fetal Medicine, Juliane Marie Centre</name>
      <address>
        <city>Copenhagen O</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>June 26, 2013</last_update_submitted>
  <last_update_submitted_qc>June 26, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 27, 2013</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</investigator_title>
  </responsible_party>
  <keyword>Simulation efficiency</keyword>
  <keyword>Collaborative learning</keyword>
  <!-- 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/NCT01703975
org study id: DRVK-35596
nct id: NCT01703975
lead sponsor: 
collaborator: 
has dmc: No
Virtual Reality (VR) simulation has enabled high-quality, safe and efficient training of
      medical health care providers. However, training costs are considerable and may be optimized
      using interventions to improve learning. The aim of this study is to compare the effects of
      training in pairs versus training alone on an VR ultrasound simulator.

      Methods: 30 medical students in their final year are randomized to either training in pairs
      or training alone. All participants are trained for two hours. Subsequently, all students are
      assessed on ultrasound performance on real patients in an ambulatory setting. Performance is
      assessed using a rating scale that has been validated in a previous study by two blinded
      assessors.
Ultrasound is becoming increasingly used in many medical specialties. However, the quality of
      the ultrasound examination is highly operator dependent and sufficient training of clinicians
      is challenging. Virtual Reality ultrasound simulation enables training under controlled
      conditions and it allows trainees to make mistakes before practicing on patients. However,
      this type of training is expensive due to costs of simulators and clinician supervisors to
      provide instructions and feedback while the trainees are practicing. Training in pairs, also
      known as dyad training, may provide a learning advantage to trainees due to shared memory and
      increased confidence. Moreover, dyad training allows training twice the number of trainees on
      simulators, which has implications to the cost-effectiveness of VR simulation.

      In this study, we examine non-inferiority of dyad training compared to the effect of
      traditional training based on clinician instruction using a VR ultrasound simulator.

      Methods Study design. A randomized observer-blinded non-inferiority study in which training
      in pairs is compared to training alone on a VR simulator.

      Pilot study. Two pilot studies were conducted to determine which modules to include in the
      training curriculum and how to provide a standardized instruction of trainees. The first
      pilot study included 10 OB/GYN residents and 10 OB/GYN consultants, who rated and commented
      each module with regards to how useful they were to pelvic ultrasound training. These ratings
      were used to develop a training curriculum consisting of a series of basic gynecologic
      training modules. The second pilot study included 6 medical students, of which half trained
      in pairs and the other half trained alone with clinician instructions. This enabled the
      research team to develop a template for the instruction that should be provided by clinician
      instructors in the group of participants that practiced alone.

      Participants. Year-six medical students in their final rotations before entering residency
      enrolled in this study. The only exclusion criterion was previous ultrasound courses or
      extra-curricular ultrasound training. 30 participants were enrolled to ensure that at least
      24 completed the transfer test.

      Setting. All participants are trained on a VR ultrasound simulator (Scantrainer, Medaphor) in
      an OB/GYN clerkship site. The Scantrainer is a high-fidelity vaginal ultrasound simulator
      that provides haptic feedback and realistic imaging.

      Randomization. All students were randomized to either training in pairs or training alone.
      Randomization was conducted at a different clinical department using computer-generated list
      of random numbers.

      Intervention. All students received 30 minutes of introduction to the simulator including a
      short introduction to vaginal ultrasound examination. The simulator instruction was provided
      using a standardized template developed in the pilot study. Constructive feedback was
      provided when participants encountered problems that they wanted feedback on. The instructor
      was a clinician ultrasound simulation expert. The participants in the intervention group did
      not receive any continuous instructor support but were allowed to consult an instructor
      whenever the participants encountered a module that they could not pass. The total training
      time was two hours in both groups. Hence, participants in the dyad group received half the
      'hands-on' time as the participants in the control group.

      Outcome measure. The outcome measure was ultrasound examination skills on pelvic ultrasound
      examination of patients in an ambulatory setting. Participants were asked to perform a
      systematic ultrasonic transvaginal examination including measurement of endometrial thickness
      and estimate the volume of the right ovary. All patients were required to provide written
      consent to participate. A blinded gynecologist rated performance using a previously validated
      rating scale.

      Sample size calculation. Based on a previous construct validation study, a difference in
      performance scores corresponding to two months of clinical experience was regarded as
      significant, which corresponded a 4.6% difference. Using a SD of 0.2, a power of 0.80 and an
      alpha of 0.05, the total number of participants required was 24.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Outcomes Assessor)
measure: Performance test
time frame: 6 hours
description: The outcome measure was ultrasound examination skills on pelvic ultrasound examination of patients in an ambulatory setting. Participants were asked to perform a systematic ultrasonic transvaginal examination including measurement of endometrial thickness and estimate the volume of the right ovary. All patients were required to provide written consent to participate. A blinded OB/GYN consultant rated performance using a previously validated rating scale.Sample size calculation and statistical methods.
measure: Confidence
time frame: 6 hours
description: Students' confidence in managing the vaginal ultrasound examination are assessed after the post-intervention performance tests
arm group label: Single training
arm group type: No Intervention
description: Students training alone on the simulator
arm group label: Training in pairs (Dyad Training)
arm group type: Experimental
description: Students training in pairs on the simulator
intervention type: Other
intervention name: Training in pairs (Dyad training)
arm group label: Training in pairs (Dyad Training)
criteria: 
gender: All
minimum age: 20 Months
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Martin G. Tolsgaard
investigator title: MD