<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/NCT03003611</url>
  </required_header>
  <id_info>
    <org_study_id>ONCO-GYNECO 2014/1</org_study_id>
    <nct_id>NCT03003611</nct_id>
  </id_info>
  <brief_title>Observational Trial on the Impact of Hypnose Used as a Sedation in Oncology Surgery in Breast Cancer</brief_title>
  <official_title>Observational Study on the Impact of Hypnose Used as Sedation in the Oncology Surgery in Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will compare the operated patients for a beginning breast cancer in the&#xD;
      Hypnose arm and the patient in the classical general anesthesia arm. It is a Observational&#xD;
      study as we cannot randomized patient, (they need to be compliant with Hypnose).&#xD;
&#xD;
      Patient will be informed that some parameters, about his recovery, will be collected from&#xD;
      their medical file. They will not have another particular treatment because they are in the&#xD;
      study. It is just a prospective data collection.&#xD;
&#xD;
      The patient will be compared on several items after the surgery ( as pain and pain killer&#xD;
      intake, the heal process of the scar, etc...) Also the investigators will compare the impact&#xD;
      of hypnose on the other treatments the patient received.&#xD;
&#xD;
      The investigators need approximately 150 patients (Half in each arm).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>How is the recovering of the patient according his pain and anxiety, one day after the surgery? Is he anxious; does algique, both or none of the two? Each patient will be categorized according the score they obtain in the different scales.</measure>
    <time_frame>One day after the surgery</time_frame>
    <description>We'll collect the following information in the standard medical file :&#xD;
The collected measures who will analyzed are anxiety, pain and consumption of analgesic.&#xD;
Items :&#xD;
Anxiety (will be mesured by the anxiety visual scale)&#xD;
Pain (mesured by analogic visual pain scale)&#xD;
consumption of analgesic (Yes / No - in case o YES : Type, duration, quantity per day) All the responses to the item will be reported and a conclusion between the part of anxiety and the part of the pain will be combine (ex : patient is anxious and have no pain, patient have pain and anxiety, patient have pain and no anxiety, patient have no pain and no anxiety).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>How is the recovering of the patient according his pain and anxiety, seven days after the surgery? Is he anxious; does algique, both or none of the two? Each patient will be categorized according the score they obtain in the different scales.</measure>
    <time_frame>7 days after surgery</time_frame>
    <description>We'll collect the following information in the standard medical file :&#xD;
The collected measures who will analyzed are anxiety, pain and consumption of analgesic.&#xD;
Items :&#xD;
Anxiety (will be mesured by the anxiety visual scale)&#xD;
Pain (mesured by analogic visual pain scale)&#xD;
consumption of analgesic (Yes / No - in case o YES : Type, duration, quantity per day) All the responses to the item will be reported and a conclusion between the part of anxiety and the part of the pain will be combine (ex : patient is anxious and have no pain, patient have pain and anxiety, patient have pain and no anxiety, patient have no pain and no anxiety).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Is the quality of the process of cure of the scar normal seven days after the surgery (according that the normal healing process is without infection and hypertrophie)?</measure>
    <time_frame>7 days post surgery</time_frame>
    <description>We'll collect the following information in the standard medical file :&#xD;
Redness of the skin : yes /no&#xD;
Delay in the scar process : yes/ no&#xD;
Infection: yes/ no&#xD;
Hypertrophie of the scar : yes/no&#xD;
Pain : Yes/No After analysis of the parameters, we will determine a good scar healing process, or not.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Early Stage Breast Carcinoma</condition>
  <arm_group>
    <arm_group_label>Hypnose</arm_group_label>
    <description>the group of patient who's operated under hypnose sedation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>traditional anesthesia</arm_group_label>
    <description>The match is realized with a patient operated in the same period as the patient in the hypnose group and it's need a comparative type of surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>hypnose sedation</intervention_name>
    <description>Patient will be anesthetized with an hypnose sedation and a complement with light anesthesia</description>
    <arm_group_label>Hypnose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>general anesthesia</intervention_name>
    <description>Patient will be anesthetized with a classical general anesthesia</description>
    <arm_group_label>traditional anesthesia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patient who will benefit of a surgery according a early stage of in-situ or infiltrated&#xD;
        breast cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent Form&#xD;
&#xD;
          -  In situ breast cancer (early stage)&#xD;
&#xD;
          -  Infiltrated Breast cancer (early stage)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No hypnoses is possible for this patient surgery&#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>Martine Berlière, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>Cliniques universitaires Saint-Luc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cliniques universitaires Saint-Luc - UCL</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>June 19, 2014</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>November 9, 2017</last_update_submitted>
  <last_update_submitted_qc>November 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2017</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>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_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/NCT03003611
org study id: ONCO-GYNECO 2014/1
nct id: NCT03003611
lead sponsor: 
has dmc: Yes
The investigators will compare the operated patients for a beginning breast cancer in the
      Hypnose arm and the patient in the classical general anesthesia arm. It is a Observational
      study as we cannot randomized patient, (they need to be compliant with Hypnose).

      Patient will be informed that some parameters, about his recovery, will be collected from
      their medical file. They will not have another particular treatment because they are in the
      study. It is just a prospective data collection.

      The patient will be compared on several items after the surgery ( as pain and pain killer
      intake, the heal process of the scar, etc...) Also the investigators will compare the impact
      of hypnose on the other treatments the patient received.

      The investigators need approximately 150 patients (Half in each arm).
observational model: Case-Control
time perspective: Prospective
measure: How is the recovering of the patient according his pain and anxiety, one day after the surgery? Is he anxious; does algique, both or none of the two? Each patient will be categorized according the score they obtain in the different scales.
time frame: One day after the surgery
description: We'll collect the following information in the standard medical file :
The collected measures who will analyzed are anxiety, pain and consumption of analgesic.
Items :
Anxiety (will be mesured by the anxiety visual scale)
Pain (mesured by analogic visual pain scale)
consumption of analgesic (Yes / No - in case o YES : Type, duration, quantity per day) All the responses to the item will be reported and a conclusion between the part of anxiety and the part of the pain will be combine (ex : patient is anxious and have no pain, patient have pain and anxiety, patient have pain and no anxiety, patient have no pain and no anxiety).
measure: How is the recovering of the patient according his pain and anxiety, seven days after the surgery? Is he anxious; does algique, both or none of the two? Each patient will be categorized according the score they obtain in the different scales.
time frame: 7 days after surgery
description: We'll collect the following information in the standard medical file :
The collected measures who will analyzed are anxiety, pain and consumption of analgesic.
Items :
Anxiety (will be mesured by the anxiety visual scale)
Pain (mesured by analogic visual pain scale)
consumption of analgesic (Yes / No - in case o YES : Type, duration, quantity per day) All the responses to the item will be reported and a conclusion between the part of anxiety and the part of the pain will be combine (ex : patient is anxious and have no pain, patient have pain and anxiety, patient have pain and no anxiety, patient have no pain and no anxiety).
measure: Is the quality of the process of cure of the scar normal seven days after the surgery (according that the normal healing process is without infection and hypertrophie)?
time frame: 7 days post surgery
description: We'll collect the following information in the standard medical file :
Redness of the skin : yes /no
Delay in the scar process : yes/ no
Infection: yes/ no
Hypertrophie of the scar : yes/no
Pain : Yes/No After analysis of the parameters, we will determine a good scar healing process, or not.
arm group label: Hypnose
description: the group of patient who's operated under hypnose sedation
arm group label: traditional anesthesia
description: The match is realized with a patient operated in the same period as the patient in the hypnose group and it's need a comparative type of surgery.
intervention type: Procedure
intervention name: hypnose sedation
description: Patient will be anesthetized with an hypnose sedation and a complement with light anesthesia
arm group label: Hypnose
intervention type: Procedure
intervention name: general anesthesia
description: Patient will be anesthetized with a classical general anesthesia
arm group label: traditional anesthesia
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Martine Berlière, MD PhD
role: Study Director
affiliation: Cliniques universitaires Saint-Luc
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Anesthetics