<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/NCT04411394</url>
  </required_header>
  <id_info>
    <org_study_id>Yeditepe.U</org_study_id>
    <nct_id>NCT04411394</nct_id>
  </id_info>
  <brief_title>The Validity and Reliability Study of Turkish Version of Body Perception Questionnaire</brief_title>
  <official_title>The Validity and Reliability Study of Turkish Version of Body Perception Questionnaire</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yeditepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yeditepe 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>
      The present study aims to determine the validity and reliability of the Turkish version of&#xD;
      the Body Perception Questionnaire (BPQ) through the Turkish translation of the questionnaire&#xD;
      and the intercultural adaptation. The Body Perception Questionnaire (BPQ) is a self-report&#xD;
      measure of body awareness and autonomic reactivity. Its items are based on the organization&#xD;
      of the autonomic nervous system (ANS), a set of neural pathways connecting the brain and&#xD;
      body.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study aims to determine the validity and reliability of the Turkish version of&#xD;
      the &quot;Body Perception Questionnaire (BPQ) through the Turkish translation of the questionnaire&#xD;
      and the intercultural adaptation. The Body Perception Questionnaire (BPQ) is a self-report&#xD;
      measure of body awareness and autonomic reactivity. Its items are based on the organization&#xD;
      of the autonomic nervous system (ANS), a set of neural pathways connecting the brain and&#xD;
      body. These pathways send information from the body about the status of organs and tissues&#xD;
      (i.e., afferent projections). Some of these incoming signals form a basis for the subjective&#xD;
      awareness of the body. The ANS also carries signals that control the functions of these&#xD;
      organs and tissues (i.e., efferent projections). These signals can alter the functions of the&#xD;
      body, depending on internal and external needs. The study includes 175 healthy participants&#xD;
      and 120 participants with anxiety. Beaton's 6-step procedure was used for translation and&#xD;
      intercultural adaptation. After the steps of the procedure were completed, the questionnaire&#xD;
      was finalized.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 3, 2019</start_date>
  <completion_date type="Actual">April 3, 2020</completion_date>
  <primary_completion_date type="Actual">January 14, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Body Perception Questionnaire</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>To understand the body perception</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospitalized Anxiety and Depression Scale</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>To understand if they have anxiety problem</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">295</enrollment>
  <condition>Body Image</condition>
  <arm_group>
    <arm_group_label>Healthy Participants</arm_group_label>
    <description>There is no intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Anxiety Participants</arm_group_label>
    <description>There is no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Body Perception Questionnaire and Hospitalized Anxiety and Depression Scale</description>
    <arm_group_label>Anxiety Participants</arm_group_label>
    <arm_group_label>Healthy Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Marmara Region&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being a volunteer to participate in the study&#xD;
&#xD;
          -  Being between the age of 18 - 77&#xD;
&#xD;
          -  Understand and follow commands&#xD;
&#xD;
          -  Not diagnosed a psychiatric disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than the age of 18&#xD;
&#xD;
          -  Reported taking psychotropic drugs and/or beta-blockers&#xD;
&#xD;
          -  Did not complete the questions&#xD;
&#xD;
          -  Having any surgical operation in the last six months&#xD;
&#xD;
          -  Diagnosed chronic cardiovascular, pulmonary or neuromuscular systemic disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>77 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Feryal Subaşı, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Yeditepe University, Faculty of Health Science</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aymen Balıkçı, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Sense On</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yeditepe University</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 5, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 30, 2020</last_update_submitted>
  <last_update_submitted_qc>May 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anxiety</keyword>
  <keyword>Body Perception Questionnaire</keyword>
  <keyword>Interoception</keyword>
  <keyword>Validity</keyword>
  <keyword>Reliability</keyword>
  <!-- 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/NCT04411394
org study id: Yeditepe.U
nct id: NCT04411394
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present study aims to determine the validity and reliability of the Turkish version of
      the Body Perception Questionnaire (BPQ) through the Turkish translation of the questionnaire
      and the intercultural adaptation. The Body Perception Questionnaire (BPQ) is a self-report
      measure of body awareness and autonomic reactivity. Its items are based on the organization
      of the autonomic nervous system (ANS), a set of neural pathways connecting the brain and
      body.
The present study aims to determine the validity and reliability of the Turkish version of
      the "Body Perception Questionnaire (BPQ) through the Turkish translation of the questionnaire
      and the intercultural adaptation. The Body Perception Questionnaire (BPQ) is a self-report
      measure of body awareness and autonomic reactivity. Its items are based on the organization
      of the autonomic nervous system (ANS), a set of neural pathways connecting the brain and
      body. These pathways send information from the body about the status of organs and tissues
      (i.e., afferent projections). Some of these incoming signals form a basis for the subjective
      awareness of the body. The ANS also carries signals that control the functions of these
      organs and tissues (i.e., efferent projections). These signals can alter the functions of the
      body, depending on internal and external needs. The study includes 175 healthy participants
      and 120 participants with anxiety. Beaton's 6-step procedure was used for translation and
      intercultural adaptation. After the steps of the procedure were completed, the questionnaire
      was finalized.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Body Perception Questionnaire
time frame: through study completion, an average of 1 year
description: To understand the body perception
measure: Hospitalized Anxiety and Depression Scale
time frame: through study completion, an average of 1 year
description: To understand if they have anxiety problem
arm group label: Healthy Participants
description: There is no intervention
arm group label: Anxiety Participants
description: There is no intervention
intervention type: Other
intervention name: Questionnaire
description: Body Perception Questionnaire and Hospitalized Anxiety and Depression Scale
arm group label: Anxiety Participants
arm group label: Healthy Participants
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 77 Years
last name: Feryal Subaşı, Professor
role: Study Chair
affiliation: Yeditepe University, Faculty of Health Science
last name: Aymen Balıkçı, MD
role: Study Chair
affiliation: Sense On
facility: 
country: Turkey
responsible party type: Sponsor