<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/NCT04483999</url>
  </required_header>
  <id_info>
    <org_study_id>VRSQ9</org_study_id>
    <nct_id>NCT04483999</nct_id>
  </id_info>
  <brief_title>Turkish Validity and Reliability Study of Virtual Reality Sickness Questionnaire</brief_title>
  <official_title>Turkish Validity and Reliability Study of Virtual Reality Sickness Questionnaire</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe 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 study is planned for the cultural adaptation and validity of the &quot;Virtual Reality&#xD;
      Sickness Questionnaire&quot;.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Virtual reality (SG) creates a virtual environment that reflects a real environment and&#xD;
      offers various experiences to users. Motion sickness can be observed in people after using&#xD;
      virtual reality applications or simulation devices in education. There are questionnaires in&#xD;
      the literature such as &quot;Simulator Sickness Questionnaire&quot; and &quot;Motion Sickness&#xD;
      Questionnaire&quot;. However, these questionnaires are specific surveys to evaluate symptoms that&#xD;
      develop after vehicle handling or use of simulation devices for pilot training, while they&#xD;
      are not ideal questionnaires to evaluate symptoms that may develop after virtual reality&#xD;
      applications. Because there are important differences between virtual reality systems and&#xD;
      simulation systems in terms of the appearance of motion disturbance symptoms. For this&#xD;
      reason, &quot;Virtual Reality Sickness Questionnaire&quot; has been developed that can evaluate these&#xD;
      symptoms.&#xD;
&#xD;
      There is no Turkish version of the &quot;Virtual Reality Sickness Questionnaire&quot; in the&#xD;
      literature. For this reason, this study is planned for the cultural adaptation and validity&#xD;
      of the &quot;Virtual Reality Sickness Questionnaire&quot;.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2021</start_date>
  <completion_date type="Actual">March 30, 2023</completion_date>
  <primary_completion_date type="Actual">January 30, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Virtual Reality Sickness Questionnaire</measure>
    <time_frame>Change from Baseline sickness after 1 hour later.</time_frame>
    <description>This questionnaire assess virtual reality sickness. This questionnaire consists of 2 subtitles as oculomotor and disorientation. It contains 9 symptoms in total. Each symptom is scored between 0 and 3 with the Likert type scoring system. Each subtitle adapted to be calculated by dividing the total score to a score system in itself like person receives%. The total score of the questionnaire will be obtained by averaging the total scores of the two subtitles.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>graybiel scale</measure>
    <time_frame>Change from Baseline sickness after 1 hour later.</time_frame>
    <description>This questionnaire assess virtual reality sickness. Total score ranges from 0-50. 0-2 points are interpreted as &quot;light susceptibility to motion sickness&quot;, 3-7 points as &quot;moderate susceptibility to motion sickness&quot;, 8-15 points as &quot;extreme susceptibility to motion sickness&quot;, and values above 16 are &quot;Definitive motion sickness&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>international physical activity questionnaire</measure>
    <time_frame>All of the participants will assess at baseline with this scale.</time_frame>
    <description>This questionnaire assess physical activity level. The physical activity levels are classified as (&lt; 600 MET-min/week), which is the physically inactive level (level I); (600-3000 METmin/week), which is the level in medium-level (level II) and (&gt; 3000 MET-min/week), which is the high physical activity level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tampa kinesiophobia scale</measure>
    <time_frame>All of the participants will assess at baseline with this scale.</time_frame>
    <description>This questionnaire assess kinesiophobia. The four-point Likert scoring is used in this scale (1 = I do not agree at all, 4 = I agree completely). The total score is calculated after reversing the items 4, 8, 12 and 16. Scoring ranges between 17 and 68 with the higher scores indicating higher levels of kinesiophobia perception.</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Sickness Behavior</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy people&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Not having mental - cognitive problems,&#xD;
&#xD;
          -  Being a volunteer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Oculomotor and vestibular disease&#xD;
&#xD;
          -  Cardiovascular, neurological and gastrointestinal problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>NEZİRE KOSE</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hacettepe University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hatice Çetin</name>
      <address>
        <city>Ankara</city>
        <state>Sıhhiye</state>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/29477332/</url>
    <description>URL</description>
  </link>
  <reference>
    <citation>Kim HK, Park J, Choi Y, Choe M. Virtual reality sickness questionnaire (VRSQ): Motion sickness measurement index in a virtual reality environment. Appl Ergon. 2018 May;69:66-73. doi: 10.1016/j.apergo.2017.12.016. Epub 2018 Jan 16.</citation>
    <PMID>29477332</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>HATİCE ÇETİN</investigator_full_name>
    <investigator_title>Research Assisstant</investigator_title>
  </responsible_party>
  <keyword>virtual reality</keyword>
  <keyword>sickness</keyword>
  <keyword>validity</keyword>
  <keyword>reliability</keyword>
  <keyword>turkish</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Illness Behavior</mesh_term>
  </condition_browse>
  <!-- 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/NCT04483999
org study id: VRSQ9
nct id: NCT04483999
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is planned for the cultural adaptation and validity of the "Virtual Reality
      Sickness Questionnaire".
Virtual reality (SG) creates a virtual environment that reflects a real environment and
      offers various experiences to users. Motion sickness can be observed in people after using
      virtual reality applications or simulation devices in education. There are questionnaires in
      the literature such as "Simulator Sickness Questionnaire" and "Motion Sickness
      Questionnaire". However, these questionnaires are specific surveys to evaluate symptoms that
      develop after vehicle handling or use of simulation devices for pilot training, while they
      are not ideal questionnaires to evaluate symptoms that may develop after virtual reality
      applications. Because there are important differences between virtual reality systems and
      simulation systems in terms of the appearance of motion disturbance symptoms. For this
      reason, "Virtual Reality Sickness Questionnaire" has been developed that can evaluate these
      symptoms.

      There is no Turkish version of the "Virtual Reality Sickness Questionnaire" in the
      literature. For this reason, this study is planned for the cultural adaptation and validity
      of the "Virtual Reality Sickness Questionnaire".
observational model: Case-Only
time perspective: Prospective
measure: Virtual Reality Sickness Questionnaire
time frame: Change from Baseline sickness after 1 hour later.
description: This questionnaire assess virtual reality sickness. This questionnaire consists of 2 subtitles as oculomotor and disorientation. It contains 9 symptoms in total. Each symptom is scored between 0 and 3 with the Likert type scoring system. Each subtitle adapted to be calculated by dividing the total score to a score system in itself like person receives%. The total score of the questionnaire will be obtained by averaging the total scores of the two subtitles.
measure: graybiel scale
time frame: Change from Baseline sickness after 1 hour later.
description: This questionnaire assess virtual reality sickness. Total score ranges from 0-50. 0-2 points are interpreted as "light susceptibility to motion sickness", 3-7 points as "moderate susceptibility to motion sickness", 8-15 points as "extreme susceptibility to motion sickness", and values above 16 are "Definitive motion sickness".
measure: international physical activity questionnaire
time frame: All of the participants will assess at baseline with this scale.
description: This questionnaire assess physical activity level. The physical activity levels are classified as (< 600 MET-min/week), which is the physically inactive level (level I); (600-3000 METmin/week), which is the level in medium-level (level II) and (> 3000 MET-min/week), which is the high physical activity level.
measure: tampa kinesiophobia scale
time frame: All of the participants will assess at baseline with this scale.
description: This questionnaire assess kinesiophobia. The four-point Likert scoring is used in this scale (1 = I do not agree at all, 4 = I agree completely). The total score is calculated after reversing the items 4, 8, 12 and 16. Scoring ranges between 17 and 68 with the higher scores indicating higher levels of kinesiophobia perception.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: NEZİRE KOSE
role: Principal Investigator
affiliation: Hacettepe University
facility: 
country: Turkey
url: https://pubmed.ncbi.nlm.nih.gov/29477332/
description: URL
citation: Kim HK, Park J, Choi Y, Choe M. Virtual reality sickness questionnaire (VRSQ): Motion sickness measurement index in a virtual reality environment. Appl Ergon. 2018 May;69:66-73. doi: 10.1016/j.apergo.2017.12.016. Epub 2018 Jan 16.
PMID: 29477332
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: HATİCE ÇETİN
investigator title: Research Assisstant
mesh term: Illness Behavior