<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/NCT04424342</url>
  </required_header>
  <id_info>
    <org_study_id>71</org_study_id>
    <nct_id>NCT04424342</nct_id>
  </id_info>
  <brief_title>Turkish Version of the Child Perceptions Questionnaire 8-10</brief_title>
  <official_title>Validity and Reliability of the Turkish Version of the Child Perceptions Questionnaire (CPQ8-10)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Recep Tayyip Erdogan University Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Recep Tayyip Erdogan University Training and Research Hospital</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 Child Perceptions Questionnaire (CPQ) is a widely used reliable measurement that provides&#xD;
      for practitioners to assess child's current emotional, social, and functional well-being. The&#xD;
      aim of the present study was to develop a translated version of CPQ8-10 into Turkish language&#xD;
      and evaluate its reliability, validity, and reproducibility.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The CPQ8-10 was translated into Turkish as recommended in the literature. The intraclass&#xD;
      correlation coefficient (ICC) was used for the test-retest reliability. The internal&#xD;
      consistency was evaluated using Cronbach's alpha Coefficient. Construct validity and&#xD;
      discriminant validity were calculated, exploratory factor analysis (EFA) and confirmatory&#xD;
      factor analysis (CFA) were employed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">November 1, 2019</completion_date>
  <primary_completion_date type="Actual">October 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the penultimate Turkish version of The Child Perceptions Questionnaire 8-10</measure>
    <time_frame>1 day</time_frame>
    <description>The questionnaire has two general questions about the sex and age of the child. The CPQ8-10 was originally composed of 25 items. Responses are recorded using a Likert scale ranging from 1 to 4: &quot;Never&quot;=0; &quot;Once or twice&quot;=1; &quot;Sometimes&quot;=2; &quot;Often&quot;=3; and &quot;Every day or almost every day&quot;=4. The total CPQ8-10 score is calculated by summing all items from four domains, which ranges from 0 to 100, with higher scores indicating worse oral health quality of life and lower scores indicating better oral health quality of life.</description>
  </primary_outcome>
  <enrollment type="Actual">418</enrollment>
  <condition>Dentist-Patient Relations</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pre-test procedure</intervention_name>
    <description>The Turkish version of CPQ8-10 was subjected to a preliminary test on a group of 20 children, who were not included in the final study, in order to discuss the intelligibility of the items and to determine comprehension problems for children of this age group</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Test re-test</intervention_name>
    <description>The Turkish version of CPQ8-10 was administered to 50 children who were asked to complete the questionnaire on their own without any assistance. These 50 children were interviewed for a second time within two weeks to measure the reliability of the test-retest</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Cross-sectional study. Patients applied for RTE University, Department of Pediatric&#xD;
        Dentisry&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  being aged between 8 and 10 years,&#xD;
&#xD;
          -  being mentally and physically sufficient to complete the questionnaire,&#xD;
&#xD;
          -  having volunteered to participate in the study,&#xD;
&#xD;
          -  speaking Turkish fluently,&#xD;
&#xD;
          -  children who were attending their first visit to the dentist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  those who were outside this age range (8-10),&#xD;
&#xD;
          -  had physical, mental or systemic disabilities that prevented them from understanding&#xD;
             and answering the CPQ8-10&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nazife Begüm KARAN</name>
      <address>
        <city>Ankara</city>
        <state>Merkez</state>
        <zip>83TR2WATUF</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Recep Tayyip Erdogan University Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Nazife Begüm KARAN</investigator_full_name>
    <investigator_title>Assistant Professor, DDS, PhD</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Beginning 3 months and ending 5 years following article publication all data can be shared with other researchers</ipd_description>
  </patient_data>
  <!-- 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/NCT04424342
org study id: 71
nct id: NCT04424342
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The Child Perceptions Questionnaire (CPQ) is a widely used reliable measurement that provides
      for practitioners to assess child's current emotional, social, and functional well-being. The
      aim of the present study was to develop a translated version of CPQ8-10 into Turkish language
      and evaluate its reliability, validity, and reproducibility.
The CPQ8-10 was translated into Turkish as recommended in the literature. The intraclass
      correlation coefficient (ICC) was used for the test-retest reliability. The internal
      consistency was evaluated using Cronbach's alpha Coefficient. Construct validity and
      discriminant validity were calculated, exploratory factor analysis (EFA) and confirmatory
      factor analysis (CFA) were employed.
observational model: Other
time perspective: Cross-Sectional
measure: Evaluation of the penultimate Turkish version of The Child Perceptions Questionnaire 8-10
time frame: 1 day
description: The questionnaire has two general questions about the sex and age of the child. The CPQ8-10 was originally composed of 25 items. Responses are recorded using a Likert scale ranging from 1 to 4: "Never"=0; "Once or twice"=1; "Sometimes"=2; "Often"=3; and "Every day or almost every day"=4. The total CPQ8-10 score is calculated by summing all items from four domains, which ranges from 0 to 100, with higher scores indicating worse oral health quality of life and lower scores indicating better oral health quality of life.
intervention type: Other
intervention name: Pre-test procedure
description: The Turkish version of CPQ8-10 was subjected to a preliminary test on a group of 20 children, who were not included in the final study, in order to discuss the intelligibility of the items and to determine comprehension problems for children of this age group
intervention type: Other
intervention name: Test re-test
description: The Turkish version of CPQ8-10 was administered to 50 children who were asked to complete the questionnaire on their own without any assistance. These 50 children were interviewed for a second time within two weeks to measure the reliability of the test-retest
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Recep Tayyip Erdogan University Training and Research Hospital
investigator full name: Nazife Begüm KARAN
investigator title: Assistant Professor, DDS, PhD
sharing ipd: Undecided
ipd description: Beginning 3 months and ending 5 years following article publication all data can be shared with other researchers