<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/NCT04428892</url>
  </required_header>
  <id_info>
    <org_study_id>ENF-19-2017</org_study_id>
    <nct_id>NCT04428892</nct_id>
  </id_info>
  <brief_title>Simulation in Physical Therapy Students</brief_title>
  <official_title>CLINICAL SIMULATION IN PHYSIOTHERAPY STUDENTS IN CLINICAL COMPETENCE FOR INTERACT WITH PEOPLE WITH LOW BACK PAIN. COLOMBIA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de la Sabana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Facultad Ciencias de La Salud Universidad de Boyaca</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidad de la Sabana</source>
  <oversight_info>
    <has_dmc>Yes</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 randomized trial included physiotherapy students, randomized in two groups, experimental&#xD;
      one included simulation for developed competencies related to clinical reasoning in&#xD;
      physiotherapy interventions for people with low back pain. The second group developed&#xD;
      role-playing. this protocol allows us to compare two strategies with simulation for to&#xD;
      promote clinical decisions in physiotherapy practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low back pain (LBP) is symptomatology with a high global prevalence; health professionals,&#xD;
      including physiotherapists, must have the skills to create professional interaction plans&#xD;
      that permit a better quality of life for consultants. Clinical simulation can be a pedagogic&#xD;
      setting that facilitates students with adequate training to acquire skills that improve&#xD;
      professional reasoning in this clinical situation. The objective of this study was to compare&#xD;
      the effects of clinical simulation with a simulated patient (SP) versus simulation with&#xD;
      role-playing (RP) in physiotherapy students for decision-making in clinical skills while&#xD;
      caring for a person with LBP. Methods. An experimental study, with 42 participants from two&#xD;
      Colombian universities, randomized into two groups (SP n = 21, RP n = 21). The clinical skill&#xD;
      was evaluated during the interaction with a person with LBP for which the Objective&#xD;
      Structured Clinical Examination (OSCE-ML) was validated for individuals with low back pain;&#xD;
      thereafter, a pedagogical method was conducted that included clinical simulation and,&#xD;
      finally, the OSCE-ML was applied again to compare both groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">December 20, 2019</completion_date>
  <primary_completion_date type="Actual">May 20, 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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical reasoning</measure>
    <time_frame>1 Month</time_frame>
    <description>The Objetive structured Clinical Evaluation (OSCE) was designed and validated, with the proposal to asses the physiotherapeutic clinical reasoning in Low Back Pain people, The OCSE have included 7 stations for assesing the clinical reasoning students.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Simulation Training</condition>
  <arm_group>
    <arm_group_label>Clinical Simulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group denominated SP received a teaching strategy based on a class session with simulated practice for decision-making in clinical skills when caring for a person with LBP. Each session lasted approximately 120 minutes, and the clinical case used for the SP sessions was subjected to face validity with experts in the area of study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Pedagogical strategy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>received a class session based on a &quot;role playing&quot; simulation strategy, structured for the same purpose established in the SP group. This session lasted approximately 120 minutes, and the learning environment was the classroom in which students assumed different roles to act out; some of them acted as people with LBP and others as physiotherapists</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pedagogyc Strategy</intervention_name>
    <description>Simulation can be used as a pedagogic tool that provides students with significant learning regarding decision-making in interacting with people, in this case patients with LBP. It is a potential strategy for developing diverse skills focused on the safety of the patient and the therapist.</description>
    <arm_group_label>Clinical Simulation</arm_group_label>
    <arm_group_label>Conventional Pedagogical strategy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physiotherapy students in five-semester from Universidad de La Sabana and Universidad&#xD;
             de Boyacá&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under-age subjects&#xD;
&#xD;
          -  those who had been internally or externally transferred from another academic program&#xD;
             in health,&#xD;
&#xD;
          -  exchange students&#xD;
&#xD;
          -  those repeating&#xD;
&#xD;
          -  with prior experiences in simulated practice in other assignments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>23 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Carolina Sandoval</name>
      <address>
        <city>Tunja</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04428892
org study id: ENF-19-2017
nct id: NCT04428892
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This randomized trial included physiotherapy students, randomized in two groups, experimental
      one included simulation for developed competencies related to clinical reasoning in
      physiotherapy interventions for people with low back pain. The second group developed
      role-playing. this protocol allows us to compare two strategies with simulation for to
      promote clinical decisions in physiotherapy practice.
Low back pain (LBP) is symptomatology with a high global prevalence; health professionals,
      including physiotherapists, must have the skills to create professional interaction plans
      that permit a better quality of life for consultants. Clinical simulation can be a pedagogic
      setting that facilitates students with adequate training to acquire skills that improve
      professional reasoning in this clinical situation. The objective of this study was to compare
      the effects of clinical simulation with a simulated patient (SP) versus simulation with
      role-playing (RP) in physiotherapy students for decision-making in clinical skills while
      caring for a person with LBP. Methods. An experimental study, with 42 participants from two
      Colombian universities, randomized into two groups (SP n = 21, RP n = 21). The clinical skill
      was evaluated during the interaction with a person with LBP for which the Objective
      Structured Clinical Examination (OSCE-ML) was validated for individuals with low back pain;
      thereafter, a pedagogical method was conducted that included clinical simulation and,
      finally, the OSCE-ML was applied again to compare both groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
measure: clinical reasoning
time frame: 1 Month
description: The Objetive structured Clinical Evaluation (OSCE) was designed and validated, with the proposal to asses the physiotherapeutic clinical reasoning in Low Back Pain people, The OCSE have included 7 stations for assesing the clinical reasoning students.
arm group label: Clinical Simulation
arm group type: Experimental
description: The group denominated SP received a teaching strategy based on a class session with simulated practice for decision-making in clinical skills when caring for a person with LBP. Each session lasted approximately 120 minutes, and the clinical case used for the SP sessions was subjected to face validity with experts in the area of study.
arm group label: Conventional Pedagogical strategy
arm group type: Active Comparator
description: received a class session based on a "role playing" simulation strategy, structured for the same purpose established in the SP group. This session lasted approximately 120 minutes, and the learning environment was the classroom in which students assumed different roles to act out; some of them acted as people with LBP and others as physiotherapists
intervention type: Behavioral
intervention name: Pedagogyc Strategy
description: Simulation can be used as a pedagogic tool that provides students with significant learning regarding decision-making in interacting with people, in this case patients with LBP. It is a potential strategy for developing diverse skills focused on the safety of the patient and the therapist.
arm group label: Clinical Simulation
arm group label: Conventional Pedagogical strategy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 23 Years
healthy volunteers: No
facility: 
country: Colombia
responsible party type: Sponsor
sharing ipd: Undecided