<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/NCT04405219</url>
  </required_header>
  <id_info>
    <org_study_id>2018/05</org_study_id>
    <nct_id>NCT04405219</nct_id>
  </id_info>
  <brief_title>Smoking Cessation, Anxiety, Pain Relationship</brief_title>
  <official_title>Preoperative Smoking Cessation, Preoperative Anxiety, Postoperative Anxiety and Pain Relationship</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuzuncu Yıl University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuzuncu Yıl University</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>
      Smoking, anxiety and pain are clearly related conditions. We aimed to reveal the relationship&#xD;
      between smoking cessation before surgery and preoperative anxiety, postoperative anxiety and&#xD;
      pain in chronic smokers.&#xD;
&#xD;
      METHODS ASA I-II group patients without chronic disease and history of drug use were included&#xD;
      in the study. Those who did not want to participate in the study, patients with ASA III and&#xD;
      above were excluded from the study. The patients were randomized into 2 groups: smokers&#xD;
      (Group S, n = 60) and non-smokers (Group NS, n = 60). Group S was asked to quit smoking 2&#xD;
      weeks before the operation. Preoperative period and postoperative 0, 2, 4. And 6. hour&#xD;
      Spielberger State-Trait Anxiety Inventory (STAI) values, postop 0., 2., 4., 6. hour Visual&#xD;
      Analogue Scale (VAS) values were recorded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      it has been revealed in the current study that smoking, pain and anxiety are interrelated&#xD;
      with each other. In the preoperative period, high anxiety scores are related to surgery and&#xD;
      anesthesia stress. High anxiety scores in the smoker group both in the preoperative period&#xD;
      and in the postoperative period are associated with smoking cessation. While the pain scores&#xD;
      were similar in the postoperative period, high anxiety scores strengthened the idea of&#xD;
      smoking withdrawal and this study gained value. We believe that future studies with a large&#xD;
      number of patients, with different parameters and multiple centers will strengthen the&#xD;
      results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 17, 2018</start_date>
  <completion_date type="Actual">January 13, 2020</completion_date>
  <primary_completion_date type="Actual">February 18, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>2 hours</time_frame>
    <description>assesed with STAI form</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain scores</measure>
    <time_frame>2 hours</time_frame>
    <description>independent of anxiety, assesed with VAS scores</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Smoking Cessation</condition>
  <condition>Anxiety</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>smokers (S)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>non smokers (NS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The Relationship Between Preoperative Smoking Cessation, Anxiety, Pain</intervention_name>
    <description>Preoperative anxiety high score suggests stress related to surgery and anesthesia. High anxiety scores independent of post-operative pain showed smoking withdrawal.</description>
    <arm_group_label>non smokers (NS)</arm_group_label>
    <arm_group_label>smokers (S)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I,II patients&#xD;
&#xD;
          -  planned Rhinoplasti cases&#xD;
&#xD;
          -  accepted participating study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with chronic systemic disorders,&#xD;
&#xD;
          -  ASA III and above situation&#xD;
&#xD;
          -  emergency and bleeding cases,&#xD;
&#xD;
          -  patients with any cardiac and neurological disorders,&#xD;
&#xD;
          -  refused to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arzu Esen Tekeli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>yuzuncu yil</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Van Yuzuncu Yil University Faculty of Medicine Department of anesthesiology and reanimation</name>
      <address>
        <city>Van</city>
        <state>Tuşba</state>
        <zip>65080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Van Yuzuncu Yil University</name>
      <address>
        <city>Van</city>
        <state>Tuşba</state>
        <zip>65080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yuzuncu Yıl University</investigator_affiliation>
    <investigator_full_name>Arzu Esen Tekeli</investigator_full_name>
    <investigator_title>Assistant Professor Doctor</investigator_title>
  </responsible_party>
  <keyword>Smoking Cessation</keyword>
  <keyword>anxiety</keyword>
  <keyword>pain</keyword>
  <keyword>VAS Scores</keyword>
  <keyword>STAI Values</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>Undecided</sharing_ipd>
    <ipd_description>I do not want to share before publishing</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/NCT04405219
org study id: 2018/05
nct id: NCT04405219
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Smoking, anxiety and pain are clearly related conditions. We aimed to reveal the relationship
      between smoking cessation before surgery and preoperative anxiety, postoperative anxiety and
      pain in chronic smokers.

      METHODS ASA I-II group patients without chronic disease and history of drug use were included
      in the study. Those who did not want to participate in the study, patients with ASA III and
      above were excluded from the study. The patients were randomized into 2 groups: smokers
      (Group S, n = 60) and non-smokers (Group NS, n = 60). Group S was asked to quit smoking 2
      weeks before the operation. Preoperative period and postoperative 0, 2, 4. And 6. hour
      Spielberger State-Trait Anxiety Inventory (STAI) values, postop 0., 2., 4., 6. hour Visual
      Analogue Scale (VAS) values were recorded.
it has been revealed in the current study that smoking, pain and anxiety are interrelated
      with each other. In the preoperative period, high anxiety scores are related to surgery and
      anesthesia stress. High anxiety scores in the smoker group both in the preoperative period
      and in the postoperative period are associated with smoking cessation. While the pain scores
      were similar in the postoperative period, high anxiety scores strengthened the idea of
      smoking withdrawal and this study gained value. We believe that future studies with a large
      number of patients, with different parameters and multiple centers will strengthen the
      results.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Anxiety
time frame: 2 hours
description: assesed with STAI form
measure: pain scores
time frame: 2 hours
description: independent of anxiety, assesed with VAS scores
arm group label: smokers (S)
arm group type: Sham Comparator
arm group label: non smokers (NS)
arm group type: Active Comparator
intervention type: Other
intervention name: The Relationship Between Preoperative Smoking Cessation, Anxiety, Pain
description: Preoperative anxiety high score suggests stress related to surgery and anesthesia. High anxiety scores independent of post-operative pain showed smoking withdrawal.
arm group label: non smokers (NS)
arm group label: smokers (S)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Arzu Esen Tekeli, MD
role: Principal Investigator
affiliation: yuzuncu yil
facility: 
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Yuzuncu Yıl University
investigator full name: Arzu Esen Tekeli
investigator title: Assistant Professor Doctor
mesh term: Anxiety Disorders
sharing ipd: Undecided
ipd description: I do not want to share before publishing