<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/NCT04413981</url>
  </required_header>
  <id_info>
    <org_study_id>746</org_study_id>
    <nct_id>NCT04413981</nct_id>
  </id_info>
  <brief_title>Evaluation the Preoperative Anxiety Level of the Surgeons</brief_title>
  <official_title>Evaluation the Preoperative Anxiety Level of the Surgeons</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adana City Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Adana City Training and Research Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many studies are present about the preoperative anxiety among patients. But the preoperative&#xD;
      anxiety of the surgeons is not studied yet. The aim of this study is to evaluate the&#xD;
      preoperative anxiety of the surgeons.100 surgeons consisted of performing operations in&#xD;
      general surgery, obstetric and gynecology , orthopedic surgery ,ophthalmology,&#xD;
      otorhinolaryngology, plastic and reconstructive surgery, urology, gynecologic oncology,&#xD;
      surgical oncology, cardiovascular surgery, pediatric surgery and neurosurgery will be&#xD;
      participated in the study. Surgeons will be chosen from the specialist doctor, assistant&#xD;
      doctor, doctor lecturer, associate professor and professors.15 minutes prior to the first&#xD;
      elective operation of the day, salivary cortisol samples will be taken from the surgeons and&#xD;
      they will be asked to fill the evaluation form and State-Trait Anxiety Inventory Form (STAI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      100 surgeons between the ages of 25-55 years will be participated in the study. Surgeons will&#xD;
      be consisted of performing operations in general surgery, obstetric and gynecology,&#xD;
      orthopedic surgery, ophthalmology, otorhinolaryngology, plastic and reconstructive surgery,&#xD;
      urology, gynecologic oncology, surgical oncology, cardiovascular surgery, pediatric surgery&#xD;
      and neurosurgery.They will be chosen from the specialist doctor, assistant doctor, doctor&#xD;
      lecturer, associate professor and professors. Oral and written informed consent will be&#xD;
      obtained from the surgeons.15 minutes prior to the first elective operation of the day&#xD;
      salivary cortisol samples will be taken from the surgeons and they will be asked to fill the&#xD;
      evaluation form and State-Trait Anxiety Inventory Form (STAI). The evaluation form will&#xD;
      include the age, gender of the surgeon, surgical department, academic superscription, years&#xD;
      of clinical experience in medical sciences and professions and the name of the surgery which&#xD;
      is going to be done.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 20, 2021</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>State Trait Anxiety Inventory (STAI)</measure>
    <time_frame>up to 15 minutes</time_frame>
    <description>State Trait Anxiety Inventory (STAI) form</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum cortisol sample</measure>
    <time_frame>up to 5 minutes</time_frame>
    <description>Samples will be taken 15 minutes prior to the first elective surgery of the day</description>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Preoperative Anxiety</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      salivary cortisol&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Surgeons will be consisted of performing operations in general surgery, obstetric and&#xD;
        gynecology, orthopedic surgery, ophtalmology, otorhinolaryngology, plastic and&#xD;
        reconstructive surgery, urology, gynecologic oncology, surgical oncology, cardiovascular&#xD;
        surgery, pediatric surgery and neurosurgery.They will be chosen from the specialist doctor,&#xD;
        assistant doctor, doctor lecturer, associate professor and professors.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Accepting to participate the study&#xD;
&#xD;
          -  Surgeons planning first elective operation of the day&#xD;
&#xD;
          -  25-55 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non volunteers&#xD;
&#xD;
          -  Neurological and psychological disorders&#xD;
&#xD;
          -  History of anxiolytic , antidepressant drug usage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tuna Şahin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Adana City Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tuna Şahin</name>
      <address>
        <city>Adana</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>February 3, 2022</last_update_submitted>
  <last_update_submitted_qc>February 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Adana City Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Tuna Şahin</investigator_full_name>
    <investigator_title>Specialist of Anesthesiology and Reanimation</investigator_title>
  </responsible_party>
  <keyword>surgeon</keyword>
  <keyword>cortisol</keyword>
  <keyword>anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety 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>


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/NCT04413981
org study id: 746
nct id: NCT04413981
lead sponsor: 
is fda regulated drug: No
Many studies are present about the preoperative anxiety among patients. But the preoperative
      anxiety of the surgeons is not studied yet. The aim of this study is to evaluate the
      preoperative anxiety of the surgeons.100 surgeons consisted of performing operations in
      general surgery, obstetric and gynecology , orthopedic surgery ,ophthalmology,
      otorhinolaryngology, plastic and reconstructive surgery, urology, gynecologic oncology,
      surgical oncology, cardiovascular surgery, pediatric surgery and neurosurgery will be
      participated in the study. Surgeons will be chosen from the specialist doctor, assistant
      doctor, doctor lecturer, associate professor and professors.15 minutes prior to the first
      elective operation of the day, salivary cortisol samples will be taken from the surgeons and
      they will be asked to fill the evaluation form and State-Trait Anxiety Inventory Form (STAI).
100 surgeons between the ages of 25-55 years will be participated in the study. Surgeons will
      be consisted of performing operations in general surgery, obstetric and gynecology,
      orthopedic surgery, ophthalmology, otorhinolaryngology, plastic and reconstructive surgery,
      urology, gynecologic oncology, surgical oncology, cardiovascular surgery, pediatric surgery
      and neurosurgery.They will be chosen from the specialist doctor, assistant doctor, doctor
      lecturer, associate professor and professors. Oral and written informed consent will be
      obtained from the surgeons.15 minutes prior to the first elective operation of the day
      salivary cortisol samples will be taken from the surgeons and they will be asked to fill the
      evaluation form and State-Trait Anxiety Inventory Form (STAI). The evaluation form will
      include the age, gender of the surgeon, surgical department, academic superscription, years
      of clinical experience in medical sciences and professions and the name of the surgery which
      is going to be done.
observational model: Cohort
time perspective: Cross-Sectional
measure: State Trait Anxiety Inventory (STAI)
time frame: up to 15 minutes
description: State Trait Anxiety Inventory (STAI) form
measure: Serum cortisol sample
time frame: up to 5 minutes
description: Samples will be taken 15 minutes prior to the first elective surgery of the day
salivary cortisol
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tuna Şahin
role: Principal Investigator
affiliation: Adana City Training and Research Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Adana City Training and Research Hospital
investigator full name: Tuna Şahin
investigator title: Specialist of Anesthesiology and Reanimation
mesh term: Anxiety Disorders
sharing ipd: No