<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/NCT02967601</url>
  </required_header>
  <id_info>
    <org_study_id>shiv01</org_study_id>
    <nct_id>NCT02967601</nct_id>
  </id_info>
  <brief_title>Influence of Preoperative Anxiety on Shivering During Elective Caesarean Section Under Spinal Anaesthesia</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bartłomiej Wódarski</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre of Postgraduate Medical Education</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background Shivering occurs in circa 50 percent of cases during caesarean section under&#xD;
      spinal anesthesia. The phenomenon's reasons and its mechanism are unclear, and while it does&#xD;
      not endanger the patients' health, the sensations proved to be unpleasant and a subject of a&#xD;
      number of patients' complains.&#xD;
&#xD;
      Objectives The main objective of the study is to establish the anxiety factors that influence&#xD;
      the risk of muscle-shivering and a detailed assessment of the probability of existence of the&#xD;
      link between increased anxiety levels with the shivering in case of patients undergoing the&#xD;
      elective caesarean section.&#xD;
&#xD;
      Moreover, the outcomes of the study could help to further understand the phenomenon, reduce&#xD;
      its occurence and as a result of that - improve the comfort of the patients in the&#xD;
      perioperative period, as well as reduce the frequency of pharmacological treatment to halt&#xD;
      the symptoms of muscle shivering.&#xD;
&#xD;
      Methodology Patients would be asked to fill the STAI (State - Trait Anxiety Inventory)&#xD;
      questionaire in the morning preceding the surgery. Results would be interpreted by one of the&#xD;
      investigators, who obtained a masters degree in psychology. Caesarean section under spinal&#xD;
      anesthesia would be performed according to standard procedures used in the Samodzielny&#xD;
      Publiczny Szpital Kliniczny Centrum Medyczne Kształcenia Podyplomowego (SPSK CMKP) hospital,&#xD;
      with standard non-invasive monitoring (HR, noninvasive blood pressure (NIBP), oxygen&#xD;
      saturation (SpO2), Temperature). Additionally, the anesthesiologist would note the incidence&#xD;
      of shivering and its precise timing 1. since the spinal block 2. since the child-birth.&#xD;
      Moreover, patients would rate anesthesiology team influence on her anxiety level during the&#xD;
      cesarean section in 5 grade scale - data would be collected by psychologist.&#xD;
&#xD;
      The survey is planned for a one year timespan or until 200 patients have enrolled.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between shivering and anxiety (STAI score)</measure>
    <time_frame>during elective cesarean section</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between shivering and patient's temperature (noninvasive)</measure>
    <time_frame>during elective cesarean section</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between shivering and patient's subjective assesment of anesthesiology team attitude</measure>
    <time_frame>during elective cesarean section</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between shivering and patient's obstetric history socio-economical data.</measure>
    <time_frame>during elective cesarean section</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Shivering</condition>
  <arm_group>
    <arm_group_label>Elective Cesarean Section</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>STAI (State Trait Anxiety Inventory) questionaire</intervention_name>
    <description>Each patient would fill the STAI questionaire before Cesarean Section (on the same day, in the morning)</description>
    <arm_group_label>Elective Cesarean Section</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women undergoing an Elective Ceasearean Section, qualified for spinal anaesthesia with&#xD;
        American Society of Anesthesiologists (ASA) physical status classification system I-II.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18 y.o.&#xD;
&#xD;
          -  ASA 1-2&#xD;
&#xD;
          -  signed informed consent form after reading the information about the study and talking&#xD;
             with one of the investigators&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  conversion to general anesthesia&#xD;
&#xD;
          -  any severe obstetric complications, which affects obstetric or anesthesiology&#xD;
             procedure&#xD;
&#xD;
          -  severe bleeding&#xD;
&#xD;
          -  language barrier&#xD;
&#xD;
          -  anxiolytic/psychotropic drugs use&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Samodzielny Publiczny Szpital Kliniczny im. prof. W. Orłowskiego w Warszawie</name>
      <address>
        <city>Warsaw</city>
        <state>Masovian</state>
        <zip>00-416</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>January 6, 2018</last_update_submitted>
  <last_update_submitted_qc>January 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Centre of Postgraduate Medical Education</investigator_affiliation>
    <investigator_full_name>Bartłomiej Wódarski</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>shivering, cesarean section, anxiety, STAI</keyword>
  <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/NCT02967601
org study id: shiv01
nct id: NCT02967601
lead sponsor: 
has dmc: No
Background Shivering occurs in circa 50 percent of cases during caesarean section under
      spinal anesthesia. The phenomenon's reasons and its mechanism are unclear, and while it does
      not endanger the patients' health, the sensations proved to be unpleasant and a subject of a
      number of patients' complains.

      Objectives The main objective of the study is to establish the anxiety factors that influence
      the risk of muscle-shivering and a detailed assessment of the probability of existence of the
      link between increased anxiety levels with the shivering in case of patients undergoing the
      elective caesarean section.

      Moreover, the outcomes of the study could help to further understand the phenomenon, reduce
      its occurence and as a result of that - improve the comfort of the patients in the
      perioperative period, as well as reduce the frequency of pharmacological treatment to halt
      the symptoms of muscle shivering.

      Methodology Patients would be asked to fill the STAI (State - Trait Anxiety Inventory)
      questionaire in the morning preceding the surgery. Results would be interpreted by one of the
      investigators, who obtained a masters degree in psychology. Caesarean section under spinal
      anesthesia would be performed according to standard procedures used in the Samodzielny
      Publiczny Szpital Kliniczny Centrum Medyczne Kształcenia Podyplomowego (SPSK CMKP) hospital,
      with standard non-invasive monitoring (HR, noninvasive blood pressure (NIBP), oxygen
      saturation (SpO2), Temperature). Additionally, the anesthesiologist would note the incidence
      of shivering and its precise timing 1. since the spinal block 2. since the child-birth.
      Moreover, patients would rate anesthesiology team influence on her anxiety level during the
      cesarean section in 5 grade scale - data would be collected by psychologist.

      The survey is planned for a one year timespan or until 200 patients have enrolled.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Correlation between shivering and anxiety (STAI score)
time frame: during elective cesarean section
measure: Correlation between shivering and patient's temperature (noninvasive)
time frame: during elective cesarean section
measure: Correlation between shivering and patient's subjective assesment of anesthesiology team attitude
time frame: during elective cesarean section
measure: Correlation between shivering and patient's obstetric history socio-economical data.
time frame: during elective cesarean section
arm group label: Elective Cesarean Section
intervention type: Behavioral
intervention name: STAI (State Trait Anxiety Inventory) questionaire
description: Each patient would fill the STAI questionaire before Cesarean Section (on the same day, in the morning)
arm group label: Elective Cesarean Section
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Poland
responsible party type: Sponsor-Investigator
investigator affiliation: Centre of Postgraduate Medical Education
investigator full name: Bartłomiej Wódarski
investigator title: MD
sharing ipd: No