<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/NCT03261414</url>
  </required_header>
  <id_info>
    <org_study_id>2013_54</org_study_id>
    <secondary_id>2014-A00622-45</secondary_id>
    <nct_id>NCT03261414</nct_id>
  </id_info>
  <brief_title>HYSTERIA Evaluation of Clinical HYpnosis After Surgical Resection for Crohn Disease on Post-operative Analgesia</brief_title>
  <acronym>HYSTERIA</acronym>
  <official_title>Prospective Randomized Study Evaluating the Effect of Pre-operative Hypnosis on Anesthesia, Analgesia and Perioperative Stress Laparoscopic Ileo-caecal Resections of Crohn's Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</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>
      The aim of this study will be to show a decrease in postoperative morphine consumption by the&#xD;
      practice of perioperative self-hypnosis in patients undergoing laparoscopic ileo-caecal&#xD;
      resection for Crohn's disease&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 27, 2015</start_date>
  <completion_date type="Actual">January 30, 2020</completion_date>
  <primary_completion_date type="Actual">January 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total morphine consumption</measure>
    <time_frame>During the first 24 postoperative hours</time_frame>
    <description>Compare the cumulative morphine consumption during 24 hours postoperative Data from PCA pump and patient medical record</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total morphine consumption</measure>
    <time_frame>between the 24 and the 48 postoperative hours</time_frame>
    <description>Compare the cumulative morphine consumption between the 24 and the 48 postoperative hours Data from PCA pump and patient medical record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of patients with complications</measure>
    <time_frame>during first 7 postoperative days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative consumption of hypnotics and opioids</measure>
    <time_frame>during first 7 postoperative days</time_frame>
    <description>The hypnotics and opioids drug dose will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antiemetics consumption</measure>
    <time_frame>during first 7 postoperative days</time_frame>
    <description>The antiemetic drug dose will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative nausea and vomiting (PONV) Score</measure>
    <time_frame>first 24 postoperative hours</time_frame>
    <description>PONV risk assessment tool Based on apfel's simplified risk score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospital stay</measure>
    <time_frame>during first 7 postoperative days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time physiological function recovery</measure>
    <time_frame>during first 7 postoperative days</time_frame>
    <description>Ability to drink, to eat, to urinate, to walk</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>With preoperative hypnosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>standard care plus hypnosis followed by administration of propofol for anesthesia induction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Without preoperative hypnosis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>standard care without preoperative hypnosis followed by administration of propofol for anesthesia induction</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hypnosis</intervention_name>
    <description>A short preanesthetic hypnosis before induction of anesthesia</description>
    <arm_group_label>With preoperative hypnosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>usual care</intervention_name>
    <description>Standard care before induction of anesthesia</description>
    <arm_group_label>Without preoperative hypnosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being affected by a crohn's disease, reaching the small intestine (ileal or&#xD;
             ileo-colic) and requiring ileo-caecal resection by laparoscopy&#xD;
&#xD;
          -  Never been operated for abdominal crohn's disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  A history of intestinal resection for crohn's disease&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Corticotherapy in progress&#xD;
&#xD;
          -  Deaf patients&#xD;
&#xD;
          -  non-Francophone Patients&#xD;
&#xD;
          -  Patients with knowledge of self-hypnosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe Zerbib, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Claude Huriez</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>March 8, 2021</last_update_submitted>
  <last_update_submitted_qc>March 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</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/NCT03261414
org study id: 2013_54
secondary id: 2014-A00622-45
nct id: NCT03261414
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study will be to show a decrease in postoperative morphine consumption by the
      practice of perioperative self-hypnosis in patients undergoing laparoscopic ileo-caecal
      resection for Crohn's disease
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Total morphine consumption
time frame: During the first 24 postoperative hours
description: Compare the cumulative morphine consumption during 24 hours postoperative Data from PCA pump and patient medical record
measure: Total morphine consumption
time frame: between the 24 and the 48 postoperative hours
description: Compare the cumulative morphine consumption between the 24 and the 48 postoperative hours Data from PCA pump and patient medical record
measure: Total number of patients with complications
time frame: during first 7 postoperative days
measure: Intraoperative consumption of hypnotics and opioids
time frame: during first 7 postoperative days
description: The hypnotics and opioids drug dose will be recorded
measure: Antiemetics consumption
time frame: during first 7 postoperative days
description: The antiemetic drug dose will be recorded
measure: Postoperative nausea and vomiting (PONV) Score
time frame: first 24 postoperative hours
description: PONV risk assessment tool Based on apfel's simplified risk score
measure: Duration of hospital stay
time frame: during first 7 postoperative days
measure: Time physiological function recovery
time frame: during first 7 postoperative days
description: Ability to drink, to eat, to urinate, to walk
arm group label: With preoperative hypnosis
arm group type: Experimental
description: standard care plus hypnosis followed by administration of propofol for anesthesia induction
arm group label: Without preoperative hypnosis
arm group type: Active Comparator
description: standard care without preoperative hypnosis followed by administration of propofol for anesthesia induction
intervention type: Procedure
intervention name: Hypnosis
description: A short preanesthetic hypnosis before induction of anesthesia
arm group label: With preoperative hypnosis
intervention type: Procedure
intervention name: usual care
description: Standard care before induction of anesthesia
arm group label: Without preoperative hypnosis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philippe Zerbib, MD,PhD
role: Principal Investigator
affiliation: University Hospital of Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Crohn Disease
mesh term: Inflammatory Bowel Diseases