xml: <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/NCT06034184</url>
    </required_header>
    <id_info>
      <org_study_id>EPM:2023-02154-02</org_study_id>
      <nct_id>NCT06034184</nct_id>
    </id_info>
    <brief_title>Enhancing Mass Casualty Triage Through Virtual Reality Simulation</brief_title>
    <acronym>VR-MCI-RCT</acronym>
    <official_title>To Evaluate Whether Virtual Reality Compared to Standard Education Improves Nursing Students' Ability to Triage in a Simulated Mass Casualty Incident- a RCT</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sophiahemmet University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Falck Ambulance A/S</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>CrashCourse AB</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Sophiahemmet University</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 observational study aims to investigate whether Virtual Reality (VR) compared to&#xD;
        traditional education and training, can enhance the correct triage abilities of nursing&#xD;
        students in simulated mass casualty incidents (MCI). The primary research question seeks to&#xD;
        answer if VR compared to Standard education supports students' ability to triage correctly in&#xD;
        a simulated MCI situation. Additionally, this study aims to address the following secondary&#xD;
        questions: Does VR compared to standard education have an effect on the time to triage in a&#xD;
        simulated MCI situation? And, does VR compared to Standard education have an effect on&#xD;
        theoretical knowledge retention concerning triage in MCI situations? In the interventional&#xD;
        group, participants will utilize VR for MCI training and learning, while the control group&#xD;
        will undergo standard education, including lectures and paper exercises. The researchers will&#xD;
        compare the two groups of nursing students to assess whether VR yields better outcomes in MCI&#xD;
        triage education.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A randomized controlled trial (RCT) involving nursing students from a university in&#xD;
        Stockholm, Sweden. The students are randomly allocated in a 1:1 ratio to either VR&#xD;
        (intervention) or standard training in triaging during a mass casualty Incident. Both groups&#xD;
        of participants will receive the same lecture on disaster events and triage using the same&#xD;
        method before undergoing triage training either with VR support or traditional paper-based&#xD;
        training. To achieve a power of 0.80 and a p-value of 0.05, a total of 60 participants are&#xD;
        required (control n=30, intervention n=30). However, all students (approximately 100) will be&#xD;
        invited to participate in the study to avoid excluding those who wish to take part in the&#xD;
        study. The primary outcome measure is the students' ability to triage correctly. Secondary&#xD;
        outcome measures include knowledge and knowledge retention, as well as the time taken to&#xD;
        triage correctly. Knowledge tests will be conducted approximately one week after training and&#xD;
        again 3-6 months after completing the training. The knowledge test consists of a&#xD;
        questionnaire with 20 multiple-choice questions used in previous studies.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</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>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Ability to performe correct criage</measure>
      <time_frame>From enrollment, theoretical education and performing training on mass casualty incidents with or without Virtual Reality</time_frame>
      <description>Measuring if VR compared to Standard education has an effect on the frequency of correctly triage</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Effect on Time</measure>
      <time_frame>From enrollment, theoretical education and performing training on mass casualty incidents with or without Virtual Reality</time_frame>
      <description>Measuring if VR compared to Standard education has an effect on the time to triage correctly (10 patients) in a simulated MCI situation</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Knowledge retention</measure>
      <time_frame>From enrollment, the training on mass casualty incidents with or without Virtual Reality and measuring nursing students theoretical knowledge retention on triage 1 week- 3-6 months after training.</time_frame>
      <description>To measure if VR compared to Standard education has an effect on theoretical knowledge retention</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Learning</condition>
    <condition>Mass Casualty Incident</condition>
    <condition>Triage</condition>
    <condition>Training</condition>
    <arm_group>
      <arm_group_label>Using Virtual Reality for training and learning mass casualty incidents</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The nursing students use glasses and handcontrollers (High Fidelity Simulation) in the VR scenario for training and learning mass casualty incidents.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard education and training</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Standard education, including lectures and paper exercises</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Virtual Reality</intervention_name>
      <description>The nursing students use glasses and handcontrollers (High Fidelity Simulation) in the VR scenario for training and learning mass casualty incidents.</description>
      <arm_group_label>Using Virtual Reality for training and learning mass casualty incidents</arm_group_label>
      <other_name>Training mass casualty incidents</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Nursing students registered for a course in disaster medicine/emergency care that is&#xD;
          conducted during their fifth semester (out of 6) in the nursing program.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Does not meet inclusion criteria&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Veronica Lindström, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sophiahemmet University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Veronica AC Lindström, RN, PhD</last_name>
      <phone>+46703428157</phone>
      <email>veronica.lindstrom@shh.se</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sara Heldring, RN, MSc</last_name>
      <phone>+46707653931</phone>
      <email>sara.heldring@shh.se</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sophiahemmet University, Lindstedtvägen 8</name>
        <address>
          <city>Stockholm</city>
          <zip>11428</zip>
          <country>Sweden</country>
        </address>
      </facility>
      <contact>
        <last_name>Sara Heldring, RN, MSc</last_name>
        <phone>+46707653931</phone>
        <email>sara.heldring@shh.se</email>
      </contact>
      <contact_backup>
        <last_name>Mari Lundberg, Professor, PhD</last_name>
        <phone>+4684062091</phone>
        <email>mari.lundberg@shh.se</email>
      </contact_backup>
      <investigator>
        <last_name>Veronica Lindström, Professor, RN, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sophiahemmet University</investigator_affiliation>
      <investigator_full_name>Veronica Lindström</investigator_full_name>
      <investigator_title>Professor and Registered Nurse</investigator_title>
    </responsible_party>
    <keyword>Virtual Reality</keyword>
    <keyword>Mass casualty incidents</keyword>
    <keyword>Triage</keyword>
    <keyword>Learning</keyword>
    <keyword>Nursing Students</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The data analyzed and presented will be available from the PI and/or corresponding author (when published) on reasonable request</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06034184
  org study id: EPM:2023-02154-02
  nct id: NCT06034184
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This observational study aims to investigate whether Virtual Reality (VR) compared to
        traditional education and training, can enhance the correct triage abilities of nursing
        students in simulated mass casualty incidents (MCI). The primary research question seeks to
        answer if VR compared to Standard education supports students' ability to triage correctly in
        a simulated MCI situation. Additionally, this study aims to address the following secondary
        questions: Does VR compared to standard education have an effect on the time to triage in a
        simulated MCI situation? And, does VR compared to Standard education have an effect on
        theoretical knowledge retention concerning triage in MCI situations? In the interventional
        group, participants will utilize VR for MCI training and learning, while the control group
        will undergo standard education, including lectures and paper exercises. The researchers will
        compare the two groups of nursing students to assess whether VR yields better outcomes in MCI
        triage education.
  A randomized controlled trial (RCT) involving nursing students from a university in
        Stockholm, Sweden. The students are randomly allocated in a 1:1 ratio to either VR
        (intervention) or standard training in triaging during a mass casualty Incident. Both groups
        of participants will receive the same lecture on disaster events and triage using the same
        method before undergoing triage training either with VR support or traditional paper-based
        training. To achieve a power of 0.80 and a p-value of 0.05, a total of 60 participants are
        required (control n=30, intervention n=30). However, all students (approximately 100) will be
        invited to participate in the study to avoid excluding those who wish to take part in the
        study. The primary outcome measure is the students' ability to triage correctly. Secondary
        outcome measures include knowledge and knowledge retention, as well as the time taken to
        triage correctly. Knowledge tests will be conducted approximately one week after training and
        again 3-6 months after completing the training. The knowledge test consists of a
        questionnaire with 20 multiple-choice questions used in previous studies.
  allocation: Randomized
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Ability to performe correct criage
  time frame: From enrollment, theoretical education and performing training on mass casualty incidents with or without Virtual Reality
  description: Measuring if VR compared to Standard education has an effect on the frequency of correctly triage
  measure: Effect on Time
  time frame: From enrollment, theoretical education and performing training on mass casualty incidents with or without Virtual Reality
  description: Measuring if VR compared to Standard education has an effect on the time to triage correctly (10 patients) in a simulated MCI situation
  measure: Knowledge retention
  time frame: From enrollment, the training on mass casualty incidents with or without Virtual Reality and measuring nursing students theoretical knowledge retention on triage 1 week- 3-6 months after training.
  description: To measure if VR compared to Standard education has an effect on theoretical knowledge retention
  arm group label: Using Virtual Reality for training and learning mass casualty incidents
  arm group type: Experimental
  description: The nursing students use glasses and handcontrollers (High Fidelity Simulation) in the VR scenario for training and learning mass casualty incidents.
  arm group label: Standard education and training
  arm group type: No Intervention
  description: Standard education, including lectures and paper exercises
  intervention type: Other
  intervention name: Virtual Reality
  description: The nursing students use glasses and handcontrollers (High Fidelity Simulation) in the VR scenario for training and learning mass casualty incidents.
  arm group label: Using Virtual Reality for training and learning mass casualty incidents
  other name: Training mass casualty incidents
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Veronica Lindström, PhD
  role: Principal Investigator
  affiliation: Sophiahemmet University
  last name: Veronica AC Lindström, RN, PhD
  phone: +46703428157
  email: veronica.lindstrom@shh.se
  last name: Sara Heldring, RN, MSc
  phone: +46707653931
  email: sara.heldring@shh.se
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: Sweden
  responsible party type: Principal Investigator
  investigator affiliation: Sophiahemmet University
  investigator full name: Veronica Lindström
  investigator title: Professor and Registered Nurse
  sharing ipd: No
  ipd description: The data analyzed and presented will be available from the PI and/or corresponding author (when published) on reasonable request