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/NCT06035822</url>
    </required_header>
    <id_info>
      <org_study_id>SIM_DEB_LCJR</org_study_id>
      <nct_id>NCT06035822</nct_id>
    </id_info>
    <brief_title>Assessment of Nursing Students' Performance During Guided Debriefing With the Lasater Clinical Judgement Rubric</brief_title>
    <acronym>SIM_LCJR</acronym>
    <official_title>Assessment of Nursing Students' Performance During Guided Debriefing With the Lasater Clinical Judgement Rubric: a Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Vic - Central University of Catalonia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Vic - Central University of Catalonia</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>
        I invite you to participate in the study entitled Use of debriefing as a training tool in&#xD;
        simulation, of which Montserrat Faro-Basco is not the main researcher. The study is linked to&#xD;
        the doctoral thesis Debriefing in clinical simulation, essential for the development of&#xD;
        reflective professionals, which the same researcher is carrying out as part of the UVic-UCC&#xD;
        Doctoral Program in Educational Innovation and Intervention.&#xD;
  &#xD;
        The aim of this study is:&#xD;
  &#xD;
        - Analysis of the effectiveness of the structured debriefing session with the TeamGAINS tool&#xD;
  &#xD;
        The procedure to follow will consist of the recording of the debriefing for the subsequent&#xD;
        analysis of the behaviors and attitudes of the participants in the session (teacher and&#xD;
        students), through its viewing.&#xD;
  &#xD;
        Participation in this activity is voluntary and does not involve any harm or danger to your&#xD;
        physical or mental health. You can refuse to participate at any time in the study without&#xD;
        having to give reasons for this, or receiving any type of penalty.&#xD;
  &#xD;
        The data obtained will be confidential, anonymity will be kept, these data will be organized&#xD;
        with a number assigned to each participant, there will be no record of the identity of the&#xD;
        participants. The data will be in charge of the research team of this study for the&#xD;
        subsequent development of reports and publications of the study results in scientific&#xD;
        journals.&#xD;
  &#xD;
        The collected information will not be used for any purpose other than those indicated.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2017</start_date>
    <completion_date type="Actual">June 30, 2021</completion_date>
    <primary_completion_date type="Actual">December 31, 2019</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>
      <intervention_model_description>The assignment of the 30 groups to the intervention or control group was randomized. Fifteen were assigned to the intervention group (IG) and were given the High-Fidelity Simulation (HFS) intervention with a debriefing script, and 15 were assigned to the control group (CG) and were given the HFS intervention without a debriefing script.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>The students did not know whether they were a control group or an intervention group</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants who have improved their performance from structured debriefing and good clinical reasoning.</measure>
      <time_frame>The evaluation instrument is applied during the debriefing analysis carried out at the end of the intervention, lasting one hour.</time_frame>
      <description>The debriefing sessions were recorded with two fixed video cameras, which were activated at the beginning of the debriefing. The purpose of the recordings was that the two facilitators and the two external evaluators could later view them in order to be able to analyze and evaluate the participants' interventions during the debriefing, applying the LCJR instrument, which allowed the assessment of the student's performance and clinical reasoning.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">89</enrollment>
    <condition>Educational Activities</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The IG debriefings (n=15) were conducted by the research teacher, who is trained in clinical simulation methodology, is a clinical simulation instructor, and is trained in the use of the TeamGAINS tool (Kolbe et al., 2013), using this tool as a debriefing script, in accordance with the objectives CSC.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The CG debriefings (n=15) were conducted by a teacher trained in clinical simulation methodology, with no experience in the use of any debriefing guide. The debriefer applied his or her experience and training in simulation to conduct the debriefings in a free-form manner, in accordance with the objectives of the clinical simulation scenario (CSC).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Debriefing with TeamGAINS</intervention_name>
      <description>The IG debriefings were conducted by the research teacher, who is trained in clinical simulation methodology, is a clinical simulation instructor, and is trained in the use of the TeamGAINS tool, using this tool as a debriefing script, in accordance with the objectives Clinical Simulation Scenario</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The inclusion criterion applied was all students enrolled in the Practicum VI subject&#xD;
               in the 2017-2018 academic year.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The exclusion criterion was students who did not wish to participate in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>c. Sagrada Familia, 7</name>
        <address>
          <city>Vic</city>
          <state>Barcelona</state>
          <zip>08500</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 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>University of Vic - Central University of Catalonia</investigator_affiliation>
      <investigator_full_name>Montserrat Faro</investigator_full_name>
      <investigator_title>Dr. Montserrat Faro-Basco</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT06035822
  org study id: SIM_DEB_LCJR
  nct id: NCT06035822
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  I invite you to participate in the study entitled Use of debriefing as a training tool in
        simulation, of which Montserrat Faro-Basco is not the main researcher. The study is linked to
        the doctoral thesis Debriefing in clinical simulation, essential for the development of
        reflective professionals, which the same researcher is carrying out as part of the UVic-UCC
        Doctoral Program in Educational Innovation and Intervention.
  
        The aim of this study is:
  
        - Analysis of the effectiveness of the structured debriefing session with the TeamGAINS tool
  
        The procedure to follow will consist of the recording of the debriefing for the subsequent
        analysis of the behaviors and attitudes of the participants in the session (teacher and
        students), through its viewing.
  
        Participation in this activity is voluntary and does not involve any harm or danger to your
        physical or mental health. You can refuse to participate at any time in the study without
        having to give reasons for this, or receiving any type of penalty.
  
        The data obtained will be confidential, anonymity will be kept, these data will be organized
        with a number assigned to each participant, there will be no record of the identity of the
        participants. The data will be in charge of the research team of this study for the
        subsequent development of reports and publications of the study results in scientific
        journals.
  
        The collected information will not be used for any purpose other than those indicated.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The assignment of the 30 groups to the intervention or control group was randomized. Fifteen were assigned to the intervention group (IG) and were given the High-Fidelity Simulation (HFS) intervention with a debriefing script, and 15 were assigned to the control group (CG) and were given the HFS intervention without a debriefing script.
  primary purpose: Other
  masking: Double (Participant, Outcomes Assessor)
  masking description: The students did not know whether they were a control group or an intervention group
  measure: Number of participants who have improved their performance from structured debriefing and good clinical reasoning.
  time frame: The evaluation instrument is applied during the debriefing analysis carried out at the end of the intervention, lasting one hour.
  description: The debriefing sessions were recorded with two fixed video cameras, which were activated at the beginning of the debriefing. The purpose of the recordings was that the two facilitators and the two external evaluators could later view them in order to be able to analyze and evaluate the participants' interventions during the debriefing, applying the LCJR instrument, which allowed the assessment of the student's performance and clinical reasoning.
  arm group label: Intervention group
  arm group type: Experimental
  description: The IG debriefings (n=15) were conducted by the research teacher, who is trained in clinical simulation methodology, is a clinical simulation instructor, and is trained in the use of the TeamGAINS tool (Kolbe et al., 2013), using this tool as a debriefing script, in accordance with the objectives CSC.
  arm group label: Control group
  arm group type: No Intervention
  description: The CG debriefings (n=15) were conducted by a teacher trained in clinical simulation methodology, with no experience in the use of any debriefing guide. The debriefer applied his or her experience and training in simulation to conduct the debriefings in a free-form manner, in accordance with the objectives of the clinical simulation scenario (CSC).
  intervention type: Other
  intervention name: Debriefing with TeamGAINS
  description: The IG debriefings were conducted by the research teacher, who is trained in clinical simulation methodology, is a clinical simulation instructor, and is trained in the use of the TeamGAINS tool, using this tool as a debriefing script, in accordance with the objectives Clinical Simulation Scenario
  arm group label: Intervention group
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: University of Vic - Central University of Catalonia
  investigator full name: Montserrat Faro
  investigator title: Dr. Montserrat Faro-Basco
  sharing ipd: Undecided