<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/NCT03281018</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2016/18</org_study_id>
    <nct_id>NCT03281018</nct_id>
  </id_info>
  <brief_title>Preoperative Hypnosis in Gynecology</brief_title>
  <acronym>HYPPOGYN</acronym>
  <official_title>Exploratory Study of the Impact of a Preoperative Formal Hypnosis Session on Perioperative Anxiety Among Female Patients Hospitalised for Hysterectomy Due to Pelvic Gynecological Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</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 research hypotheses that preoperative formal hypnosis session reduces perioperative&#xD;
      anxiety among women undergoing a hysterectomy for pelvic gynecological cancer. The key&#xD;
      objective is to estimate the effect of preoperative hypnosis on preoperative anxiety among&#xD;
      this population&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anxiety is present preoperatively in 40% of patients. The operated subjects are on average&#xD;
      20% more anxious than the general population, according to a study of 2013. Cancer as well as&#xD;
      surgery modifying the body pattern and impairing femininity are risk factors for preoperative&#xD;
      anxiety. Recent work in both children and adults has shown that significant levels of&#xD;
      preoperative anxiety increase the risk of postoperative complications and the occurrence of&#xD;
      postoperative emotional and behavioral disorders. The consequences of hysterectomy increase&#xD;
      patients' anxiety, for fear of affecting femininity, and the modification of the body&#xD;
      regimen. The prevention of preoperative anxiety in such population is therefore a major&#xD;
      issue.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 10, 2017</start_date>
  <completion_date type="Actual">June 26, 2019</completion_date>
  <primary_completion_date type="Actual">June 26, 2019</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>evolution of anxiety</measure>
    <time_frame>1 month after the surgery</time_frame>
    <description>visual analog scale (from 0, no anxiety to 10, extreme anxiety)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain</measure>
    <time_frame>The day of the consultation with anesthesist, the day before the surgery, 2 days, an average of 12 days, and 1 month after the surgery</time_frame>
    <description>numerical scale of pain (from 0, no pain, to 10, extreme pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>nausea and vomiting</measure>
    <time_frame>2 days, an average of 12 days, and 1 month after the surgery</time_frame>
    <description>frequency and intensity through an interview with a nurse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>concomitant medication</measure>
    <time_frame>The day of the consultation with anesthesist, the day before the surgery, 2 days, an average of 12 days, and 1 month after the surgery</time_frame>
    <description>concomitant medication within anxiolytic, antalgic, and/or antiemetic pharmaceutical classes (yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>medical history</measure>
    <time_frame>The day of the consultation with anesthesist</time_frame>
    <description>chronic pathologies (e.g. arterial hypertension, type 2 diabetes) (yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of hospital stay</measure>
    <time_frame>an average of 12 days after the surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hypnosis intervention feasibility (composite outcome)</measure>
    <time_frame>after the hypnosis session (average of 1 week before the surgery)</time_frame>
    <description>Compliance with the formal Hypnosis session checklist (Installation, pre-session interview, kinesthetic induction, dissociation, deepening, post-hypnotic suggestions and anchoring, return to normal wakefulness)&#xD;
Other factors: proportion of refusals, proportion of abandoned, proportion of lost sight</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Pelvic Gynecological Cancer</condition>
  <arm_group>
    <arm_group_label>Interventional arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Caregiver Accompaniment Time (CAT) + preoperative hypnosis session (experimental arm): The hypnosis session is performed by a nurse trained in medical hypnosis; this interview lasts approximately one hour and is carried out 5 to 15 days before the hospitalisation. During the hypnosis session, the patient is free to choose what issues she wants to address. The patient will then go from a state of ordinary consciousness to a modified state of consciousness. This state will allow her to activate her own resources to handle difficulties, especially anxiety. Using a post-hypnotic suggestion, the patient will be able to revisit her work at any time she needs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control (CAT)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>CAT is performed in routine care for all patients after the announcement of the illness by a trained nurse, if possible on the same day as the consultation or before the consultation of anesthesia. This is an interview of approximately 45 minutes to listen to the patient, to answer her questions and to re-explain the information delivered to her. The patient will tackle the history of the disease and then the treatment, this time dedicated evolves according to the desire of the patient and her ability to accept the disease. The patient can express her feelings, then the family circle is evoked talking about the resource persons and the future. The purpose of this interview is to obtain the autonomy of the patient by the setting up of supportive care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Caregiver Accompaniment Time (CAT) + preoperative hypnosis session</intervention_name>
    <description>The hypnosis session is performed by a nurse trained in medical hypnosis; this interview lasts approximately one hour and is carried out 5 to 15 days before the hospitalisation. During the hypnosis session, the patient is free to choose what issues she wants to address. The patient will then go from a state of ordinary consciousness to a modified state of consciousness. This state will allow her to activate her own resources to handle difficulties, especially anxiety. Using a post-hypnotic suggestion, the patient will be able to revisit her work at any time she needs</description>
    <arm_group_label>Interventional arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18yrs with pelvic gynecological cancer (endometrium, cervix, ovary),&#xD;
&#xD;
          -  at any stage of the disease;&#xD;
&#xD;
          -  patient coming for anesthesia consultation before hysterectomy,&#xD;
&#xD;
          -  informed signed consent,&#xD;
&#xD;
          -  patient affiliated to or beneficiary of social security.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient &lt;18yrs,&#xD;
&#xD;
          -  patient with a pelvic gynecological cancer that does not require hysterectomy;&#xD;
&#xD;
          -  patient with psychiatric history or a depressive syndrome;&#xD;
&#xD;
          -  deaf patient (deafness makes the hypnosis session impossible),&#xD;
&#xD;
          -  patient under legal protection.&#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>Jennie SOURZAC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Bordeaux</name>
      <address>
        <city>Bordeau</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>July 4, 2019</last_update_submitted>
  <last_update_submitted_qc>July 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hypnosis</keyword>
  <keyword>preoperative anxiety</keyword>
  <keyword>hysterectomy</keyword>
  <keyword>hospitalisation</keyword>
  <!-- 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/NCT03281018
org study id: CHUBX 2016/18
nct id: NCT03281018
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The research hypotheses that preoperative formal hypnosis session reduces perioperative
      anxiety among women undergoing a hysterectomy for pelvic gynecological cancer. The key
      objective is to estimate the effect of preoperative hypnosis on preoperative anxiety among
      this population
Anxiety is present preoperatively in 40% of patients. The operated subjects are on average
      20% more anxious than the general population, according to a study of 2013. Cancer as well as
      surgery modifying the body pattern and impairing femininity are risk factors for preoperative
      anxiety. Recent work in both children and adults has shown that significant levels of
      preoperative anxiety increase the risk of postoperative complications and the occurrence of
      postoperative emotional and behavioral disorders. The consequences of hysterectomy increase
      patients' anxiety, for fear of affecting femininity, and the modification of the body
      regimen. The prevention of preoperative anxiety in such population is therefore a major
      issue.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: evolution of anxiety
time frame: 1 month after the surgery
description: visual analog scale (from 0, no anxiety to 10, extreme anxiety)
measure: pain
time frame: The day of the consultation with anesthesist, the day before the surgery, 2 days, an average of 12 days, and 1 month after the surgery
description: numerical scale of pain (from 0, no pain, to 10, extreme pain)
measure: nausea and vomiting
time frame: 2 days, an average of 12 days, and 1 month after the surgery
description: frequency and intensity through an interview with a nurse
measure: concomitant medication
time frame: The day of the consultation with anesthesist, the day before the surgery, 2 days, an average of 12 days, and 1 month after the surgery
description: concomitant medication within anxiolytic, antalgic, and/or antiemetic pharmaceutical classes (yes/no)
measure: medical history
time frame: The day of the consultation with anesthesist
description: chronic pathologies (e.g. arterial hypertension, type 2 diabetes) (yes/no)
measure: length of hospital stay
time frame: an average of 12 days after the surgery
measure: hypnosis intervention feasibility (composite outcome)
time frame: after the hypnosis session (average of 1 week before the surgery)
description: Compliance with the formal Hypnosis session checklist (Installation, pre-session interview, kinesthetic induction, dissociation, deepening, post-hypnotic suggestions and anchoring, return to normal wakefulness)
Other factors: proportion of refusals, proportion of abandoned, proportion of lost sight
arm group label: Interventional arm
arm group type: Experimental
description: Caregiver Accompaniment Time (CAT) + preoperative hypnosis session (experimental arm): The hypnosis session is performed by a nurse trained in medical hypnosis; this interview lasts approximately one hour and is carried out 5 to 15 days before the hospitalisation. During the hypnosis session, the patient is free to choose what issues she wants to address. The patient will then go from a state of ordinary consciousness to a modified state of consciousness. This state will allow her to activate her own resources to handle difficulties, especially anxiety. Using a post-hypnotic suggestion, the patient will be able to revisit her work at any time she needs
arm group label: Control (CAT)
arm group type: No Intervention
description: CAT is performed in routine care for all patients after the announcement of the illness by a trained nurse, if possible on the same day as the consultation or before the consultation of anesthesia. This is an interview of approximately 45 minutes to listen to the patient, to answer her questions and to re-explain the information delivered to her. The patient will tackle the history of the disease and then the treatment, this time dedicated evolves according to the desire of the patient and her ability to accept the disease. The patient can express her feelings, then the family circle is evoked talking about the resource persons and the future. The purpose of this interview is to obtain the autonomy of the patient by the setting up of supportive care
intervention type: Behavioral
intervention name: Caregiver Accompaniment Time (CAT) + preoperative hypnosis session
description: The hypnosis session is performed by a nurse trained in medical hypnosis; this interview lasts approximately one hour and is carried out 5 to 15 days before the hospitalisation. During the hypnosis session, the patient is free to choose what issues she wants to address. The patient will then go from a state of ordinary consciousness to a modified state of consciousness. This state will allow her to activate her own resources to handle difficulties, especially anxiety. Using a post-hypnotic suggestion, the patient will be able to revisit her work at any time she needs
arm group label: Interventional arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jennie SOURZAC
role: Principal Investigator
affiliation: University Hospital, Bordeaux
facility: 
country: France
responsible party type: Sponsor