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/NCT05994352</url>
    </required_header>
    <id_info>
      <org_study_id>IstanbulArelU</org_study_id>
      <nct_id>NCT05994352</nct_id>
    </id_info>
    <brief_title>Psychiatric Nursing Students Therapeutic Communication</brief_title>
    <official_title>The Effect Of Vırtual Realıty Applıcatıon On Therapeutıc Communıcatıon Skılls Levels Of Mental Health And Psychıatrıc Nursıng Students</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Arel University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Arel 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 research was carried out to determine the effect of virtual reality application on the&#xD;
        therapeutic communication skill levels of Mental Health and Psychiatric Nursing course&#xD;
        students. The research was carried out in experimental research design. The independent&#xD;
        variable of the research is virtual reality simulation; The dependent variable is the&#xD;
        therapeutic communication skills of the students of the Mental Health and Psychiatric Nursing&#xD;
        course. Nursing students' individual characteristics were determined as the control variable.&#xD;
        The hypothesis of the research H1: The therapeutic communication skill level scores of the&#xD;
        nursing students in the intervention group participating in the virtual reality simulation&#xD;
        will increase compared to the nursing students in the control group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This research was carried out to determine the effect of virtual reality application on the&#xD;
        therapeutic communication skill levels of Mental Health and Psychiatric Nursing course&#xD;
        students. The analysis was carried out in an experimental research design. The independent&#xD;
        variable of the study is virtual reality simulation; The dependent variable is the&#xD;
        therapeutic communication skills of the students of the Mental Health and Psychiatric Nursing&#xD;
        course. Nursing students' characteristics were determined as the control variable. The&#xD;
        hypothesis of the research H1: The therapeutic communication skill level scores of the&#xD;
        nursing students in the intervention group participating in the virtual reality simulation&#xD;
        will increase compared to those in the control group. The population of the research consists&#xD;
        of 65 students who are enrolled in the nursing department of a foundation university in&#xD;
        Istanbul and took the mental health and psychiatric nursing course in the spring term of the&#xD;
        2022-2023 academic year. Sample: A list from 1 to 65 was prepared to determine the students&#xD;
        who will take place in the intervention and control groups. Simple random sampling method was&#xD;
        used to differentiate between intervention and control groups. The numbers to be sampled were&#xD;
        determined by www.random.org generate number. The intervention group consisted of 36 students&#xD;
        and the control group consisted of 29 students.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">December 1, 2022</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</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>Randomized controlled</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The therapeutic communication skill levels of mental health and psychiatric nursing students</measure>
      <time_frame>4 mounth</time_frame>
      <description>descriptive characteristics of the participants. The form, consisting of 7 questions in total, containing information such as the age, gender, place of residence of the students for the longest time, presence of mental illness, was prepared by the researcher using the literature</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Nursing students' therapeutic communication skills</measure>
      <time_frame>4 mounth</time_frame>
      <description>The scale developed by Karaca, et al. (2019) was designed as a measurement tool for determining the therapeutic communication skills of nursing students. The scale consists of 16 items and 3 sub-dimensions: &quot;Non-therapeutic Communication Skills&quot;, &quot;Therapeutic Communication Skills-1&quot;, &quot;Therapeutic Communication Skills-2&quot;. The first sub-dimension of my scale consists of 7 items, the second sub-dimension consists of 6 items and the third sub-dimension consists of 3 items. The scale is 7-point Likert type varying between 1 and 7, there is no reverse coded item in the scale. The highest score that can be obtained from the scale is 16x7=112, and the lowest score is 16x1=16.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">65</enrollment>
    <condition>Communication</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>no intervention will be applied to the students in the control group</description>
    </arm_group>
    <arm_group>
      <arm_group_label>experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>virtual reality simulation will be applied to the experimental group</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>virtual reality simulation</intervention_name>
      <description>The effect of virtual reality simulation on therapeutic communication skill levels</description>
      <arm_group_label>experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • To be registered in the Mental Health and Psychiatric Nursing course in the spring&#xD;
               semester of the 2022-2023 academic year,&#xD;
  &#xD;
                 -  To be taking the Mental Health and Psychiatric Nursing course for the first time&#xD;
                    in the nursing department,&#xD;
  &#xD;
                 -  To attend school regularly,&#xD;
  &#xD;
                 -  Not having received training with virtual reality simulation within the scope of&#xD;
                    Mental Health and Psychiatric Nursing course.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>21 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Arzu Dikici</last_name>
      <role>Principal Investigator</role>
      <affiliation>lecturer</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Istanbul Arel University</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Arel University</investigator_affiliation>
      <investigator_full_name>Arzu Dikici</investigator_full_name>
      <investigator_title>lecturer</investigator_title>
    </responsible_party>
    <keyword>therapeutic</keyword>
    <keyword>communication</keyword>
    <keyword>mental health</keyword>
    <keyword>nursing</keyword>
    <keyword>student</keyword>
    <!-- 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/NCT05994352
  org study id: IstanbulArelU
  nct id: NCT05994352
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This research was carried out to determine the effect of virtual reality application on the
        therapeutic communication skill levels of Mental Health and Psychiatric Nursing course
        students. The research was carried out in experimental research design. The independent
        variable of the research is virtual reality simulation; The dependent variable is the
        therapeutic communication skills of the students of the Mental Health and Psychiatric Nursing
        course. Nursing students' individual characteristics were determined as the control variable.
        The hypothesis of the research H1: The therapeutic communication skill level scores of the
        nursing students in the intervention group participating in the virtual reality simulation
        will increase compared to the nursing students in the control group.
  This research was carried out to determine the effect of virtual reality application on the
        therapeutic communication skill levels of Mental Health and Psychiatric Nursing course
        students. The analysis was carried out in an experimental research design. The independent
        variable of the study is virtual reality simulation; The dependent variable is the
        therapeutic communication skills of the students of the Mental Health and Psychiatric Nursing
        course. Nursing students' characteristics were determined as the control variable. The
        hypothesis of the research H1: The therapeutic communication skill level scores of the
        nursing students in the intervention group participating in the virtual reality simulation
        will increase compared to those in the control group. The population of the research consists
        of 65 students who are enrolled in the nursing department of a foundation university in
        Istanbul and took the mental health and psychiatric nursing course in the spring term of the
        2022-2023 academic year. Sample: A list from 1 to 65 was prepared to determine the students
        who will take place in the intervention and control groups. Simple random sampling method was
        used to differentiate between intervention and control groups. The numbers to be sampled were
        determined by www.random.org generate number. The intervention group consisted of 36 students
        and the control group consisted of 29 students.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized controlled
  primary purpose: Basic Science
  masking: Single (Participant)
  measure: The therapeutic communication skill levels of mental health and psychiatric nursing students
  time frame: 4 mounth
  description: descriptive characteristics of the participants. The form, consisting of 7 questions in total, containing information such as the age, gender, place of residence of the students for the longest time, presence of mental illness, was prepared by the researcher using the literature
  measure: Nursing students' therapeutic communication skills
  time frame: 4 mounth
  description: The scale developed by Karaca, et al. (2019) was designed as a measurement tool for determining the therapeutic communication skills of nursing students. The scale consists of 16 items and 3 sub-dimensions: "Non-therapeutic Communication Skills", "Therapeutic Communication Skills-1", "Therapeutic Communication Skills-2". The first sub-dimension of my scale consists of 7 items, the second sub-dimension consists of 6 items and the third sub-dimension consists of 3 items. The scale is 7-point Likert type varying between 1 and 7, there is no reverse coded item in the scale. The highest score that can be obtained from the scale is 16x7=112, and the lowest score is 16x1=16.
  arm group label: control group
  arm group type: No Intervention
  description: no intervention will be applied to the students in the control group
  arm group label: experimental group
  arm group type: Experimental
  description: virtual reality simulation will be applied to the experimental group
  intervention type: Other
  intervention name: virtual reality simulation
  description: The effect of virtual reality simulation on therapeutic communication skill levels
  arm group label: experimental group
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 21 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Arzu Dikici
  role: Principal Investigator
  affiliation: lecturer
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul Arel University
  investigator full name: Arzu Dikici
  investigator title: lecturer