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/NCT06022783</url>
    </required_header>
    <id_info>
      <org_study_id>2023-KAEK-655</org_study_id>
      <nct_id>NCT06022783</nct_id>
    </id_info>
    <brief_title>Effect of Virtual Reality Intervention on Stress Levels of Surgical Nurses</brief_title>
    <official_title>The Effectiveness of Virtual Reality Intervention on Stress Levels of Surgical Nurses: A Crossover Designed Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Trakya University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Trakya University</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>
        The aim this crossover designed study is to examine the effect of watching a relaxing video&#xD;
        with using virtual reality glasses (VR-G) during the break period of a working shift on the&#xD;
        stress levels of surgical nurses.&#xD;
  &#xD;
        Nurses will be asked to watch a relaxing video with using VR-G for 20 minutes at their break&#xD;
        time (the first procedure).&#xD;
  &#xD;
        After one-week wash-out period, researchers will compare second procedure (no video watch&#xD;
        with VR-G) to see if there is any difference on the stress levels of the nurses.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Allocation of the nurses to the procedure groups (with VR-G and no VR-G procedures) is done&#xD;
        with using Random Allocation Software program.&#xD;
  &#xD;
        Among the with VR-G procedure:&#xD;
  &#xD;
        The nurses were asked to watch a relaxing video with using VR-G for 20 minutes at their break&#xD;
        time. The researcher visited the nurses at the beginning of the working shift and asked the&#xD;
        nurse stress scale items to them in the nursing room, scheduled a break period with them&#xD;
        individually and visited them again at the scheduled time. Then, the researcher prepared the&#xD;
        video and googles, asked nurses to sit on the chair in the nursing room at the surgical unit,&#xD;
        helped them to wear the VR-G and let them alone to watch the video for 20 minutes.&#xD;
  &#xD;
        At the end of their working shift, the researcher visited them and asked the scale items once&#xD;
        again.&#xD;
  &#xD;
        Among the no VR-G procedure:&#xD;
  &#xD;
        The nurses did not watch any video and copleted their routine working shift and break times.&#xD;
        The researcher visited the nurses at the beginning and at the end of their working shift and&#xD;
        asked the nurse stress scale items to them in the nursing room.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 24, 2023</start_date>
    <completion_date type="Actual">August 4, 2023</completion_date>
    <primary_completion_date type="Actual">July 24, 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>Crossover Assignment</intervention_model>
      <intervention_model_description>crossover designed randomized controlled study</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The data analysed by a independent researcher from the data collection and coding procedures.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Stress level</measure>
      <time_frame>At the beginning and end of nurses daily working shift through study completion, an average of six months.</time_frame>
      <description>will be evaluated with using the &quot;Nurse Stress Scale (NSS)&quot; which is developed by Gray-Toft and Anderson and, translated and validated in Turkish by Mert, Sayilan and Baydemir. This scale consists of seven subcategories and 34 positive items rated using a 4-point Likert scoring system &quot;1-never&quot;, &quot;2-sometimes&quot;, 3-often,&quot; &quot;4-very often&quot;. The total scale score, which reflects the frequency of the stress experienced by nurses, ranges from 34 to 136 points. A higher score indicates more frequent stress, while a lower score indicates less stress for the same situations.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Nurse</condition>
    <condition>Stress</condition>
    <condition>Virtual Reality</condition>
    <arm_group>
      <arm_group_label>with VR-G</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The nurses in this procedure were asked to watch a relaxing video with using VR-G for 20 minutes at their break time.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>no VR-G</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The nurses in this procedure did not watch any video and completed their routine working shift and break times.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Virtual reality intervention</intervention_name>
      <description>Watching a relaxing video with using VR-G for 20 minutes</description>
      <arm_group_label>with VR-G</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  working in a surgical unit for at least one year&#xD;
  &#xD;
            -  able to use virtual reality glasses&#xD;
  &#xD;
            -  volunteering to participate in this study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  having a visual and/or audial problems&#xD;
  &#xD;
            -  leaving surgical unit for any reason&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Seher Ünver</last_name>
      <role>Principal Investigator</role>
      <affiliation>Trakya University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Seda C Yeniğün</last_name>
      <role>Principal Investigator</role>
      <affiliation>Akdeniz University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Seher Ünver</name>
        <address>
          <city>Edirne</city>
          <zip>22030</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Trakya University</name>
        <address>
          <city>Edirne</city>
          <zip>22030</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Trakya University</investigator_affiliation>
      <investigator_full_name>Seher Ünver</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>surgical nurses</keyword>
    <keyword>stress</keyword>
    <keyword>virtual reality intervention</keyword>
    <patient_data>
      <sharing_ipd>No</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/NCT06022783
  org study id: 2023-KAEK-655
  nct id: NCT06022783
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim this crossover designed study is to examine the effect of watching a relaxing video
        with using virtual reality glasses (VR-G) during the break period of a working shift on the
        stress levels of surgical nurses.
  
        Nurses will be asked to watch a relaxing video with using VR-G for 20 minutes at their break
        time (the first procedure).
  
        After one-week wash-out period, researchers will compare second procedure (no video watch
        with VR-G) to see if there is any difference on the stress levels of the nurses.
  Allocation of the nurses to the procedure groups (with VR-G and no VR-G procedures) is done
        with using Random Allocation Software program.
  
        Among the with VR-G procedure:
  
        The nurses were asked to watch a relaxing video with using VR-G for 20 minutes at their break
        time. The researcher visited the nurses at the beginning of the working shift and asked the
        nurse stress scale items to them in the nursing room, scheduled a break period with them
        individually and visited them again at the scheduled time. Then, the researcher prepared the
        video and googles, asked nurses to sit on the chair in the nursing room at the surgical unit,
        helped them to wear the VR-G and let them alone to watch the video for 20 minutes.
  
        At the end of their working shift, the researcher visited them and asked the scale items once
        again.
  
        Among the no VR-G procedure:
  
        The nurses did not watch any video and copleted their routine working shift and break times.
        The researcher visited the nurses at the beginning and at the end of their working shift and
        asked the nurse stress scale items to them in the nursing room.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: crossover designed randomized controlled study
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  masking description: The data analysed by a independent researcher from the data collection and coding procedures.
  measure: Stress level
  time frame: At the beginning and end of nurses daily working shift through study completion, an average of six months.
  description: will be evaluated with using the "Nurse Stress Scale (NSS)" which is developed by Gray-Toft and Anderson and, translated and validated in Turkish by Mert, Sayilan and Baydemir. This scale consists of seven subcategories and 34 positive items rated using a 4-point Likert scoring system "1-never", "2-sometimes", 3-often," "4-very often". The total scale score, which reflects the frequency of the stress experienced by nurses, ranges from 34 to 136 points. A higher score indicates more frequent stress, while a lower score indicates less stress for the same situations.
  arm group label: with VR-G
  arm group type: Experimental
  description: The nurses in this procedure were asked to watch a relaxing video with using VR-G for 20 minutes at their break time.
  arm group label: no VR-G
  arm group type: No Intervention
  description: The nurses in this procedure did not watch any video and completed their routine working shift and break times.
  intervention type: Other
  intervention name: Virtual reality intervention
  description: Watching a relaxing video with using VR-G for 20 minutes
  arm group label: with VR-G
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Seher Ünver
  role: Principal Investigator
  affiliation: Trakya University
  last name: Seda C Yeniğün
  role: Principal Investigator
  affiliation: Akdeniz University
  facility: 
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Trakya University
  investigator full name: Seher Ünver
  investigator title: Associate Professor
  sharing ipd: No