<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/NCT03227315</url>
  </required_header>
  <id_info>
    <org_study_id>17-KAEK-077</org_study_id>
    <nct_id>NCT03227315</nct_id>
  </id_info>
  <brief_title>Is There a Relationship Between Stress Tolerance and Analgesic Consumption in Obese Patients?</brief_title>
  <official_title>Is There a Relationship Between Stress Tolerance and Analgesic Consumption in Obese Patients?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tokat Gaziosmanpasa University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tokat Gaziosmanpasa University</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>
      Preoperative anxiety level of patients affects postoperative analgesic consumption. However,&#xD;
      there were no studies that showed a relationship between the level of stress tolerance and&#xD;
      analgesic consumption in the literature. In this study, investigators wanted to investigate&#xD;
      the effect of stress tolerance on analgesic consumption of patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After approval, patients enrolled in the study is invited to complete the Pain&#xD;
      Catastrophizing Scale questionnaire, Distress Tolerance Scale and Beck anxiety scale.After&#xD;
      surgery, VAS scores of the patients will be evaluated (in the recovery room, 2,6,12 and 24&#xD;
      hours). and patients with VAS&gt; 3 will receive 2 mg of morphine.The relationship between total&#xD;
      analgesic consumption and the stress tolerance will be evaluated.The study will be performed&#xD;
      with 69 sleeve gastrectomy patients(BMI&gt;30).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Anticipated">December 10, 2017</completion_date>
  <primary_completion_date type="Anticipated">November 20, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The effect of patient anxiety tolerance on analgesic consumption</measure>
    <time_frame>one time in four months</time_frame>
    <description>Assessment of analgesic consumption according to the patient's anxiety. tolerance.The distress tolerance scale will be used for this.</description>
  </primary_outcome>
  <enrollment type="Anticipated">69</enrollment>
  <condition>Distress Tolerance</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The Patients that will happen sleeve gastrectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 18 and 60 years&#xD;
&#xD;
          -  Planned to sleeve gastrectomy&#xD;
&#xD;
          -  An American Society of Anesthesiologists score of 1 or 2 BMI&gt;30&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychiatric diseases&#xD;
&#xD;
          -  Rejected to participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hakan Tapar</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gaziosmanpasa university</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hakan Tapar</last_name>
    <phone>+9005056844496</phone>
    <email>hakantapar@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hakan Tapar</last_name>
    <phone>+9005056844496</phone>
    <email>akantapar@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Gaziosmanpasa University</name>
      <address>
        <city>Tokat</city>
        <zip>60200</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hakan Tapar, Assist.Prof.</last_name>
      <phone>+905056844496</phone>
      <email>hakantapar@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hakan Tapar</name>
      <address>
        <city>Tokat</city>
        <zip>60200</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hakan Tapar</last_name>
      <phone>03562129500-3496</phone>
      <email>hakantapar@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tokat Gaziosmanpasa University</investigator_affiliation>
    <investigator_full_name>Hakan Tapar</investigator_full_name>
    <investigator_title>Assist.Prof</investigator_title>
  </responsible_party>
  <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/NCT03227315
org study id: 17-KAEK-077
nct id: NCT03227315
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Preoperative anxiety level of patients affects postoperative analgesic consumption. However,
      there were no studies that showed a relationship between the level of stress tolerance and
      analgesic consumption in the literature. In this study, investigators wanted to investigate
      the effect of stress tolerance on analgesic consumption of patient.
After approval, patients enrolled in the study is invited to complete the Pain
      Catastrophizing Scale questionnaire, Distress Tolerance Scale and Beck anxiety scale.After
      surgery, VAS scores of the patients will be evaluated (in the recovery room, 2,6,12 and 24
      hours). and patients with VAS> 3 will receive 2 mg of morphine.The relationship between total
      analgesic consumption and the stress tolerance will be evaluated.The study will be performed
      with 69 sleeve gastrectomy patients(BMI>30).
observational model: Case-Only
time perspective: Prospective
measure: The effect of patient anxiety tolerance on analgesic consumption
time frame: one time in four months
description: Assessment of analgesic consumption according to the patient's anxiety. tolerance.The distress tolerance scale will be used for this.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Hakan Tapar
role: Principal Investigator
affiliation: Gaziosmanpasa university
last name: Hakan Tapar
phone: +9005056844496
email: hakantapar@hotmail.com
last name: Hakan Tapar
phone: +9005056844496
email: akantapar@hotmail.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Tokat Gaziosmanpasa University
investigator full name: Hakan Tapar
investigator title: Assist.Prof
sharing ipd: No