<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/NCT03253159</url>
  </required_header>
  <id_info>
    <org_study_id>ICM-URC-2014/30</org_study_id>
    <nct_id>NCT03253159</nct_id>
  </id_info>
  <brief_title>Added Conversational Hypnosis Reduced General Anesthesia Side Effects for Day Case Breast Surgery</brief_title>
  <acronym>HYPNOSEIN</acronym>
  <official_title>Added Conversational Hypnosis Reduced General Anesthesia Side Effects for Day Case Breast Surgery: A Prospective Randomized Phase III Clinical Trial (HYPNOSEIN)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut du Cancer de Montpellier - Val d'Aurelle</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut du Cancer de Montpellier - Val d'Aurelle</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the impact of the support in reducing postoperative adverse events in particular on&#xD;
      the pain but also on anxiety, comfort, nausea, vomiting, and fatigue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Drug premedication with anxiolytics (benzodiazepine or equivalent) are usually prescribed to&#xD;
      alleviate patient anxiety. However, alternative techniques, additional non-pharmacological,&#xD;
      have proven effective in alleviating pain and anxiety perioperative. These techniques are&#xD;
      retained relaxation therapy, reinsurance, breathing techniques and medical hypnosis as a&#xD;
      technique of choice. Regarding medical hypnosis techniques, many studies have shown that&#xD;
      performing a hypnotic technique performed perioperative could reduce the doses of&#xD;
      anesthetics, postoperative pain, length of stay in the post room Interventional (SSPI) and a&#xD;
      number of postoperative adverse effects.&#xD;
&#xD;
      Among the various techniques of hypnosis that can be offered to patients in the&#xD;
      perioperative, conversational hypnosis is to accompany the patient on admission to the block&#xD;
      to realization of general anesthesia. This technique aims to suggest a pleasant environment&#xD;
      and not anxiety.&#xD;
&#xD;
      This study evaluate the impact of this support in reducing postoperative major adverse&#xD;
      effects in particular on the pain but also on anxiety, comfort, nausea, vomiting, and&#xD;
      fatigue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">February 22, 2017</completion_date>
  <primary_completion_date type="Actual">September 2016</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>
    <intervention_model_description>Hypnosis before intravenous anesthesia versus no preparation before intravenous anesthesia</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of pain scale</measure>
    <time_frame>through study completion, an average of 5 year</time_frame>
    <description>Pain intensity assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction of the pain using Visual Analogic Scale</measure>
    <time_frame>through study completion, an average of 5 year</time_frame>
    <description>Reduction of the pain adverse postoperative outcome:&#xD;
Using Visual Analogic Scale (VAS &gt; 3/10)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Hypnosis group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The conversational hypnosis (10-15 min) is standardized and performed just before intravenous general anesthesia induction in the operative room</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No special preparation before intravenous general anesthesia induction in the operative room</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Hypnosis</intervention_name>
    <description>The conversational hypnosis (10-15 min) is standardized and performed just before intravenous general anesthesia induction in the operative room.</description>
    <arm_group_label>Hypnosis group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female &gt; 18 years&#xD;
&#xD;
          -  Patient with ASA* score 1, 2, 3&#xD;
&#xD;
          -  Minor Unilateral breast surgery indication (tumorectomy, lumpectomy, limited axillary&#xD;
             node dissection, minor breast reconstruction…)&#xD;
&#xD;
          -  Day case surgery (ambulatory surgery - living Day0-Day1)&#xD;
&#xD;
          -  General anesthesia required&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  French medical benefit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Patient with ASA score &gt; 4;&#xD;
&#xD;
          -  Body mass index &lt; 15 or 45kg/T;&#xD;
&#xD;
          -  Major Surgery indication : mastectomy, bilateral surgery, full axillary dissection,&#xD;
             major breast reconstruction&#xD;
&#xD;
          -  Patient refusing hypnosis&#xD;
&#xD;
          -  Psychic or mental Disorders&#xD;
&#xD;
          -  Chronic pain&#xD;
&#xD;
          -  Opiate therapeutic &gt; 3 months&#xD;
&#xD;
          -  Not ability to speak and read French language&#xD;
&#xD;
          -  Deaf and dumb patient&#xD;
&#xD;
          -  Under guardianship patient or guardianship&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>jibba AMRAOUI</last_name>
    <role>Study Chair</role>
    <affiliation>Institut régional du Cancer de Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut réginal du Cancer de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 29, 2016</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 7, 2020</last_update_submitted>
  <last_update_submitted_qc>August 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03253159
org study id: ICM-URC-2014/30
nct id: NCT03253159
lead sponsor: 
has dmc: No
Evaluate the impact of the support in reducing postoperative adverse events in particular on
      the pain but also on anxiety, comfort, nausea, vomiting, and fatigue.
Drug premedication with anxiolytics (benzodiazepine or equivalent) are usually prescribed to
      alleviate patient anxiety. However, alternative techniques, additional non-pharmacological,
      have proven effective in alleviating pain and anxiety perioperative. These techniques are
      retained relaxation therapy, reinsurance, breathing techniques and medical hypnosis as a
      technique of choice. Regarding medical hypnosis techniques, many studies have shown that
      performing a hypnotic technique performed perioperative could reduce the doses of
      anesthetics, postoperative pain, length of stay in the post room Interventional (SSPI) and a
      number of postoperative adverse effects.

      Among the various techniques of hypnosis that can be offered to patients in the
      perioperative, conversational hypnosis is to accompany the patient on admission to the block
      to realization of general anesthesia. This technique aims to suggest a pleasant environment
      and not anxiety.

      This study evaluate the impact of this support in reducing postoperative major adverse
      effects in particular on the pain but also on anxiety, comfort, nausea, vomiting, and
      fatigue.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Hypnosis before intravenous anesthesia versus no preparation before intravenous anesthesia
primary purpose: Prevention
masking: None (Open Label)
measure: Assessment of pain scale
time frame: through study completion, an average of 5 year
description: Pain intensity assessment
measure: Reduction of the pain using Visual Analogic Scale
time frame: through study completion, an average of 5 year
description: Reduction of the pain adverse postoperative outcome:
Using Visual Analogic Scale (VAS > 3/10)
arm group label: Hypnosis group
arm group type: Experimental
description: The conversational hypnosis (10-15 min) is standardized and performed just before intravenous general anesthesia induction in the operative room
arm group label: Control group
arm group type: No Intervention
description: No special preparation before intravenous general anesthesia induction in the operative room
intervention type: Behavioral
intervention name: Hypnosis
description: The conversational hypnosis (10-15 min) is standardized and performed just before intravenous general anesthesia induction in the operative room.
arm group label: Hypnosis group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: jibba AMRAOUI
role: Study Chair
affiliation: Institut régional du Cancer de Montpellier
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No