<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/NCT04454333</url>
  </required_header>
  <id_info>
    <org_study_id>2811</org_study_id>
    <nct_id>NCT04454333</nct_id>
  </id_info>
  <brief_title>COVID-19 in Pain Perspective</brief_title>
  <official_title>COVID-19 in Pain Perspective</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sisli Hamidiye Etfal Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sisli Hamidiye Etfal Training and Research Hospital</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>
      In our hospital's Infectious Diseases and Clinical Microbiology service, patients who have&#xD;
      been hospitalized due to Covid -19 infection have a musculoskeletal pain and headache during&#xD;
      this process, and 466 patients will be recruited to compare them with the pre-disease state&#xD;
      of the patients and to evaluate the pain status of the patients after treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This retrospectively designed study was carried out by analyzing SARS-CoV-2 infected and&#xD;
      hospitalized patients in our hospital for 2 month. The patients, whose contact information&#xD;
      can be accessed from the hospital records, will be called by phone and pain inquiries were&#xD;
      made during the SARS-CoV-2 infection process. In addition, patients' demographic data, living&#xD;
      conditions (number and characteristics of the person in the household), comorbidities,&#xD;
      symptom inquiry related to infection, duration of symptoms, length of hospitalstay,&#xD;
      pre-infection pain conditions and current pain, anxiety, depression levels and quality of&#xD;
      life will be questioned.&#xD;
&#xD;
      The pain questioning include the painful body region/s, severity (Numeric Rating Scale), type&#xD;
      of analgesic drugs used, and duration of use that occurred during infection. Anxiety and&#xD;
      depression levels will be evaluated, hospital anxiety and depression scale (HADS), and&#xD;
      quality of life will be evaluated with SF-12 health assessment questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 3, 2020</start_date>
  <completion_date type="Actual">June 20, 2020</completion_date>
  <primary_completion_date type="Actual">June 18, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric Rating Scale for Pain</measure>
    <time_frame>up to 10 weeks</time_frame>
    <description>Evaluation of severity of pain for head, back-neck and extremities by Numeric Rating Scale. Scoring will be done between 0 minimum and 10 maximum values. Higher scores mean worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>up to 10 weeks</time_frame>
    <description>Evaluation of patient's anxiety and depression level in hospital by Hospital Anxiety and Depression Scale (HADS). The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report screening scale. It contains two 7-item scales: one for anxiety and one for depression both with a score range of 0-21. Higher scores mean a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SF-12 Health assesment Questionaire</measure>
    <time_frame>up to 10 weeks</time_frame>
    <description>Evaluation of patient's quality of life by SF-12 Health assesment Questionaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). Higher scores mean a better outcome.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">466</enrollment>
  <condition>Infection</condition>
  <condition>COVID</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Hospitalized caused by COVID-19</arm_group_label>
    <description>A total of 466 patients hospitalized with the diagnosis of SARS-COV-2 at the University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital were retrospectively screened. 212 of these patients did not answer the calls, 34 of them could not be reached because they gave the wrong phone number beforehand. 4 of the patients called by the phone had communication problems due to language problems and 10 people did not want to fill the questionnaire. 206 of them were contacted by the phone and their pain and myalgia in the head, neck-back, waist, shoulder and hip regions before, during and after SARS-COV-2, their anxiety and depression levels after SARS-COV-2, and their quality of life were questioned.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        In our hospital, patients who were treated with the diagnosis of COVID-19 were selected.&#xD;
        During the selection, patients between the ages of 18-95 were selected, considering the&#xD;
        inclusion and exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with positive PCR test results obtained from combined throat and&#xD;
             nasopharyngeal swab samples&#xD;
&#xD;
          -  patients consistent with Covid-19 infection as a result of thorax computed tomography,&#xD;
             although PCR test results were negative.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have undergone surgery and trauma in the painful area in the past 3&#xD;
             months,&#xD;
&#xD;
          -  Patients with pathological disease that can cause underlying pain&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Those who have psychiatric illness and use psychiatric drugs&#xD;
&#xD;
          -  Presence of malignancy&#xD;
&#xD;
          -  Patients with severe cognitive deficits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aylin Ayyıldız, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Şişli Hamidiye Etfal Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Şişli Hamidiye Etfal Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sisli Hamidiye Etfal Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Aylin Ayyıldız</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>infections</keyword>
  <keyword>pain</keyword>
  <keyword>Coronavirus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</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/NCT04454333
org study id: 2811
nct id: NCT04454333
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In our hospital's Infectious Diseases and Clinical Microbiology service, patients who have
      been hospitalized due to Covid -19 infection have a musculoskeletal pain and headache during
      this process, and 466 patients will be recruited to compare them with the pre-disease state
      of the patients and to evaluate the pain status of the patients after treatment.
This retrospectively designed study was carried out by analyzing SARS-CoV-2 infected and
      hospitalized patients in our hospital for 2 month. The patients, whose contact information
      can be accessed from the hospital records, will be called by phone and pain inquiries were
      made during the SARS-CoV-2 infection process. In addition, patients' demographic data, living
      conditions (number and characteristics of the person in the household), comorbidities,
      symptom inquiry related to infection, duration of symptoms, length of hospitalstay,
      pre-infection pain conditions and current pain, anxiety, depression levels and quality of
      life will be questioned.

      The pain questioning include the painful body region/s, severity (Numeric Rating Scale), type
      of analgesic drugs used, and duration of use that occurred during infection. Anxiety and
      depression levels will be evaluated, hospital anxiety and depression scale (HADS), and
      quality of life will be evaluated with SF-12 health assessment questionnaire.
observational model: Cohort
time perspective: Retrospective
measure: Numeric Rating Scale for Pain
time frame: up to 10 weeks
description: Evaluation of severity of pain for head, back-neck and extremities by Numeric Rating Scale. Scoring will be done between 0 minimum and 10 maximum values. Higher scores mean worse outcome.
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: up to 10 weeks
description: Evaluation of patient's anxiety and depression level in hospital by Hospital Anxiety and Depression Scale (HADS). The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report screening scale. It contains two 7-item scales: one for anxiety and one for depression both with a score range of 0-21. Higher scores mean a worse outcome.
measure: SF-12 Health assesment Questionaire
time frame: up to 10 weeks
description: Evaluation of patient's quality of life by SF-12 Health assesment Questionaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). Higher scores mean a better outcome.
arm group label: Hospitalized caused by COVID-19
description: A total of 466 patients hospitalized with the diagnosis of SARS-COV-2 at the University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital were retrospectively screened. 212 of these patients did not answer the calls, 34 of them could not be reached because they gave the wrong phone number beforehand. 4 of the patients called by the phone had communication problems due to language problems and 10 people did not want to fill the questionnaire. 206 of them were contacted by the phone and their pain and myalgia in the head, neck-back, waist, shoulder and hip regions before, during and after SARS-COV-2, their anxiety and depression levels after SARS-COV-2, and their quality of life were questioned.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: Aylin Ayyıldız, MD
role: Principal Investigator
affiliation: Şişli Hamidiye Etfal Training and Research Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Sisli Hamidiye Etfal Training and Research Hospital
investigator full name: Aylin Ayyıldız
investigator title: Medical Doctor
mesh term: Infections