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/NCT05999045</url>
    </required_header>
    <id_info>
      <org_study_id>EASE-TR</org_study_id>
      <nct_id>NCT05999045</nct_id>
    </id_info>
    <brief_title>Turkish Version of Evaluation of the Ability to Sing Easily (EASE-TR)</brief_title>
    <official_title>Investigation of the Validity And Reliability of the Turkish Version of Evaluation of the Ability to Sing Easily (EASE-TR)</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>
        The aim of the study is to translate and culturally adapt the Turkish version of the EASE&#xD;
        (EASE-TR) scale and investigate its validity and reliability.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study consists of two phases. In the first phase of the study, the scale will be&#xD;
        translated and culturally adapted into Turkish. The second phase involves assessing&#xD;
        participants and validating the translated scale. In this phase, participants will complete&#xD;
        the EASE-TR and the severity part of the Vocal Tract Discomfort Scale (VTDS) before and after&#xD;
        a 1-hour performance. One hundred choir member between the ages of 18 and 65 will be included&#xD;
        in the study.&#xD;
  &#xD;
        Both construct and criterion validity procedures will be used.Within the scope of construct&#xD;
        validity, the &quot;Known Groups Validity&quot; method will be used based on variables such as&#xD;
        experience duration, vocal training status, and the presence or absence of current vocal&#xD;
        complaints. A comparison of pre- and post-performance EASE-TR scores will be conducted.&#xD;
        Regarding criterion validity, the correlation between EASE scores and the severity part of&#xD;
        the VTDS will be examined. For reliability, Cronbach's alpha and test-retest reliability will&#xD;
        be calculated. The questionnaire will be administered a second time to 30 participants after&#xD;
        14 days in order to measure test-retest reliability.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 10, 2023</start_date>
    <completion_date type="Anticipated">September 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Evaluation of the Ability to Sing Easily (EASE) Turkish Version score</measure>
      <time_frame>1-hour singing activity</time_frame>
      <description>Turkish Version of Evaluation of the Ability to Sing Easily score: scoring ranges from 22 to 88 with higher score meaning worse outcome</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Vocal Tract Discomfort Scale (VTDS)</measure>
      <time_frame>1-hour singing activity</time_frame>
      <description>The severity part of the Vocal Tract Discomfort Scale (VTDS): scoring ranges from 0 to 48 with higher score meaning worse outcome</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Voice Fatigue</condition>
    <arm_group>
      <arm_group_label>choir member</arm_group_label>
      <description>a person who sings in a choir</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Singing activity</intervention_name>
      <description>The singing activity will involve a 1-hour performance, rehearsal, or lesson.</description>
      <arm_group_label>choir member</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Participants who sings in a professional or unprofessional choir&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having Turkish as mother tongue&#xD;
  &#xD;
            -  Singing in choir at least 6 months&#xD;
  &#xD;
            -  Performing at least for an hour&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having previously received voice therapy or undergone voice surgery&#xD;
  &#xD;
            -  Having a systematic/or neurological disorder that may affect voice quality&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>FATMA ESEN AYDINLI, Assoc. Prof</last_name>
      <phone>+903123051093</phone>
      <email>fesen04@hacettepe.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hacettepe University</name>
        <address>
          <city>Ankara</city>
          <zip>06100</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fatma Esen Aydınlı, Assoc. Prof.</last_name>
        <phone>+90312 305 4387</phone>
        <email>fesen04@hacettepe.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hacettepe University</investigator_affiliation>
      <investigator_full_name>MERVE OGULMUS UYSAL</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Singing voice</keyword>
    <keyword>Professional voice users</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Voice Disorders</mesh_term>
    </condition_browse>
    <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/NCT05999045
  org study id: EASE-TR
  nct id: NCT05999045
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to translate and culturally adapt the Turkish version of the EASE
        (EASE-TR) scale and investigate its validity and reliability.
  The study consists of two phases. In the first phase of the study, the scale will be
        translated and culturally adapted into Turkish. The second phase involves assessing
        participants and validating the translated scale. In this phase, participants will complete
        the EASE-TR and the severity part of the Vocal Tract Discomfort Scale (VTDS) before and after
        a 1-hour performance. One hundred choir member between the ages of 18 and 65 will be included
        in the study.
  
        Both construct and criterion validity procedures will be used.Within the scope of construct
        validity, the "Known Groups Validity" method will be used based on variables such as
        experience duration, vocal training status, and the presence or absence of current vocal
        complaints. A comparison of pre- and post-performance EASE-TR scores will be conducted.
        Regarding criterion validity, the correlation between EASE scores and the severity part of
        the VTDS will be examined. For reliability, Cronbach's alpha and test-retest reliability will
        be calculated. The questionnaire will be administered a second time to 30 participants after
        14 days in order to measure test-retest reliability.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Change in Evaluation of the Ability to Sing Easily (EASE) Turkish Version score
  time frame: 1-hour singing activity
  description: Turkish Version of Evaluation of the Ability to Sing Easily score: scoring ranges from 22 to 88 with higher score meaning worse outcome
  measure: Vocal Tract Discomfort Scale (VTDS)
  time frame: 1-hour singing activity
  description: The severity part of the Vocal Tract Discomfort Scale (VTDS): scoring ranges from 0 to 48 with higher score meaning worse outcome
  arm group label: choir member
  description: a person who sings in a choir
  intervention type: Other
  intervention name: Singing activity
  description: The singing activity will involve a 1-hour performance, rehearsal, or lesson.
  arm group label: choir member
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: FATMA ESEN AYDINLI, Assoc. Prof
  phone: +903123051093
  email: fesen04@hacettepe.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Hacettepe University
  investigator full name: MERVE OGULMUS UYSAL
  investigator title: Principal Investigator
  mesh term: Voice Disorders
  sharing ipd: No