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/NCT06001008</url>
    </required_header>
    <id_info>
      <org_study_id>SÜKAEK-2022/5/12</org_study_id>
      <nct_id>NCT06001008</nct_id>
    </id_info>
    <brief_title>Validity of the Turkish Version of &quot;Perception of Quality in Anesthesia&quot;: A Prospective Observational Cohort Study</brief_title>
    <official_title>Validity of the Turkish Version of &quot;Perception of Quality in Anesthesia&quot;: A Prospective Observational Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Samsun University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Samsun University</source>
    <brief_summary>
      <textblock>
        The aim of this study is to test the validity of the Perception of Quality in Anesthesia&#xD;
        (PQA) and language compatibility.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Perception of Quality in Anesthesia (PQA) scale was developed by Hocking et al. in 2013&#xD;
        to measure the quality of anesthesia service received by patients who underwent surgery under&#xD;
        anesthesia. The survey consists of 16 questions. Researchers ask patients undergoing surgery&#xD;
        to complete the PQA questionnaire 24 hours after surgery. The researcher visits patients in&#xD;
        hospital rooms or makes phone calls the day after surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 30, 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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Construct Validity of PQA (Perception of Quality in Anesthesia)</measure>
      <time_frame>24 hours after the surgery</time_frame>
      <description>PQA is a 16-item questionnaire that measures the satisfaction of the patient with the anesthesia approach applied in the perioperative period. Survey questions assess 5 topics: Factor A: attention/courtesy; Factor B: pain management; Factor C: knowledge/trust; Factor D: POB; and Factor E: concerns addressed. For each question, the patient is asked to answer using a five-point Likert scale. The extremes of the scale are labeled 'very poor' to 'very good' or 'definitely no' to 'definitely yes' depending on the question. Patient responses to each PQA Likert scale and visual analog questions are scored from 1 to 5. 'Absolutely no' or 'very poor' is scored as 1 and 'definitely yes' or 'very good' is scored 5.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Response success rate of the PQA</measure>
      <time_frame>24 hours after the surgery</time_frame>
      <description>Defined as success if the patient has answered all items</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">140</enrollment>
    <condition>Patient Satisfaction</condition>
    <arm_group>
      <arm_group_label>General or regional anesthesia</arm_group_label>
      <description>Patients who have undergone inguinal or umbilical hernia surgery</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>PQA</intervention_name>
      <description>PQA is a questionnaire consisting of 16 questions developed to measure the quality of anesthesia service received by patients based on their experiences. Patients will be asked to answer questions by the researcher 24 hours after surgery.</description>
      <arm_group_label>General or regional anesthesia</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients undergoing electiveinguinal or umbilical hernia surgery under general or&#xD;
          regional anesthesia in Samsun University Hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients scheduled for elective inguinal or umbilical hernia surgery under general or&#xD;
               regional anesthesia&#xD;
  &#xD;
            -  Age between 18 and 80 years&#xD;
  &#xD;
            -  Ability to understand the content of surveys&#xD;
  &#xD;
            -  Native speaker of Turkish&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Emergency operation&#xD;
  &#xD;
            -  The need for postoperative intensive care&#xD;
  &#xD;
            -  Existence of mental disability&#xD;
  &#xD;
            -  Pregnancy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Mustafa SÜREN</last_name>
      <role>Study Director</role>
      <affiliation>Samsun University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dilan Akyurt</last_name>
      <phone>+905062344791</phone>
      <email>dilanakyurt@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Şenay C Adıgüzel</last_name>
      <phone>+90533 543 54 22</phone>
      <email>senaycanikli@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Dilan Akyurt</name>
        <address>
          <city>Samsun</city>
          <zip>55270</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dilan Akyurt</last_name>
        <phone>+905062344791</phone>
        <email>dilanakyurt@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Hocking G, Weightman WM, Smith C, Gibbs NM, Sherrard K. Measuring the quality of anaesthesia from a patient's perspective: development, validation, and implementation of a short questionnaire. Br J Anaesth. 2013 Dec;111(6):979-89. doi: 10.1093/bja/aet284. Epub 2013 Aug 28.</citation>
      <PMID>23985532</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Samsun University</investigator_affiliation>
      <investigator_full_name>dilan akyurt</investigator_full_name>
      <investigator_title>Specialist of Anaesthesiology and Reanimasion Principle investigator</investigator_title>
    </responsible_party>
    <keyword>Anesthesia</keyword>
    <keyword>Perioperative complications</keyword>
    <keyword>PQA</keyword>
    <!-- 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/NCT06001008
  org study id: SÜKAEK-2022/5/12
  nct id: NCT06001008
  lead sponsor: 
  The aim of this study is to test the validity of the Perception of Quality in Anesthesia
        (PQA) and language compatibility.
  The Perception of Quality in Anesthesia (PQA) scale was developed by Hocking et al. in 2013
        to measure the quality of anesthesia service received by patients who underwent surgery under
        anesthesia. The survey consists of 16 questions. Researchers ask patients undergoing surgery
        to complete the PQA questionnaire 24 hours after surgery. The researcher visits patients in
        hospital rooms or makes phone calls the day after surgery.
  observational model: Cohort
  time perspective: Prospective
  measure: Construct Validity of PQA (Perception of Quality in Anesthesia)
  time frame: 24 hours after the surgery
  description: PQA is a 16-item questionnaire that measures the satisfaction of the patient with the anesthesia approach applied in the perioperative period. Survey questions assess 5 topics: Factor A: attention/courtesy; Factor B: pain management; Factor C: knowledge/trust; Factor D: POB; and Factor E: concerns addressed. For each question, the patient is asked to answer using a five-point Likert scale. The extremes of the scale are labeled 'very poor' to 'very good' or 'definitely no' to 'definitely yes' depending on the question. Patient responses to each PQA Likert scale and visual analog questions are scored from 1 to 5. 'Absolutely no' or 'very poor' is scored as 1 and 'definitely yes' or 'very good' is scored 5.
  measure: Response success rate of the PQA
  time frame: 24 hours after the surgery
  description: Defined as success if the patient has answered all items
  arm group label: General or regional anesthesia
  description: Patients who have undergone inguinal or umbilical hernia surgery
  intervention type: Other
  intervention name: PQA
  description: PQA is a questionnaire consisting of 16 questions developed to measure the quality of anesthesia service received by patients based on their experiences. Patients will be asked to answer questions by the researcher 24 hours after surgery.
  arm group label: General or regional anesthesia
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  last name: Mustafa SÜREN
  role: Study Director
  affiliation: Samsun University
  last name: Dilan Akyurt
  phone: +905062344791
  email: dilanakyurt@gmail.com
  last name: Şenay C Adıgüzel
  phone: +90533 543 54 22
  email: senaycanikli@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Hocking G, Weightman WM, Smith C, Gibbs NM, Sherrard K. Measuring the quality of anaesthesia from a patient's perspective: development, validation, and implementation of a short questionnaire. Br J Anaesth. 2013 Dec;111(6):979-89. doi: 10.1093/bja/aet284. Epub 2013 Aug 28.
  PMID: 23985532
  responsible party type: Principal Investigator
  investigator affiliation: Samsun University
  investigator full name: dilan akyurt
  investigator title: Specialist of Anaesthesiology and Reanimasion Principle investigator