<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/NCT03755895</url>
  </required_header>
  <id_info>
    <org_study_id>2018-004527-37</org_study_id>
    <nct_id>NCT03755895</nct_id>
  </id_info>
  <brief_title>Contribution of Hypnosis to Anxiety and Pain in Brachytherapy Patients</brief_title>
  <acronym>HYCUDES</acronym>
  <official_title>Randomized Trial Comparing the Hypnosis Versus Standard Care of Anxiety and Pain in Patients With Brachytherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Cancérologie de Lorraine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut de Cancérologie de Lorraine</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>
      Formal hypnosis is a non-drug technique known to decrease anxiety and pain during the&#xD;
      preoperative procedure.&#xD;
&#xD;
      In brachytherapy, the practice of hypnosis has been shown to be feasible and beneficial for&#xD;
      patients treated for prostate cancer The goal of the study is to demonstrate the added value&#xD;
      of hypnosis during a brachytherapy detachment by improving the comfort of the patient.&#xD;
&#xD;
      The investigators want to evaluate the contribution of hypnosis during brachytherapy&#xD;
      detachment by quantifying the anxiety and pain felt by the patient during the procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2019</start_date>
  <completion_date type="Actual">May 25, 2022</completion_date>
  <primary_completion_date type="Actual">May 17, 2022</primary_completion_date>
  <phase>Phase 2</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>Anxiety evaluation</measure>
    <time_frame>1day</time_frame>
    <description>The patient's anxiety will be assessed using the State-Trait Anxiety Inventory scale (&quot;state of anxiety&quot;) before premedication (in the bedroom) and immediately after the brachytherapy detachment (in the examination room) during brachytherapy detachment using two care management: standard care versus standard care with formal hypnosis. The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety (Spielberger et al, 1983). The scale include 20 items. Higher scores indicate greater anxiety</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain evaluation: numeric scale</measure>
    <time_frame>1 day</time_frame>
    <description>Pain will be evaluated by a numeric scale before premedication (in the room), just before and just after the brachytherapy detachment (in the examination room). Patient inform their level of pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety evaluation</measure>
    <time_frame>1 day</time_frame>
    <description>Anxiety will be evaluated by a numeric scale just before and just after the brachytherapy detachment. Patient inform their level of anxiety from 0 to 10 (11 point scale) with the understanding that 0 is equal to no anxiety and 10 is equal to worst possible anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's perception of the care</measure>
    <time_frame>1day</time_frame>
    <description>The patient's perception of the care will be evaluated by a semi-directive phone interview conducted by the medical staff between day 3 and day 5 after the brachytherapy detachment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of brachytherapy detachment</measure>
    <time_frame>1day</time_frame>
    <description>The time of brachytherapy detachment will be noted from the entrance to the patient's examination room until the end of the brachytherapy detachment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Realization of the brachytherapy detachment</measure>
    <time_frame>1day</time_frame>
    <description>The ease of realization of the brachytherapy detachment and the comfort of the medical staff will be evaluated by an numeric scale at the end of the care and by a self-survey</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Cancer</condition>
  <condition>Brachytherapy</condition>
  <arm_group>
    <arm_group_label>experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients to benefit from brachytherapy detachment under KALINOX and formal hypnosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>active comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients to benefit from brachytherapy detachment under KALINOX</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>formal hypnosis</intervention_name>
    <description>patients will have brachytherapy detachment under Kalinox and formal hypnosis</description>
    <arm_group_label>experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Kalinox</intervention_name>
    <description>patients will have brachytherapy detachment under Kalinox</description>
    <arm_group_label>active comparator</arm_group_label>
    <arm_group_label>experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients ≥ 18 and ≤ 80 years&#xD;
&#xD;
          -  Patients expected to benefit a brachytherapy detachment Under KALINOX® for one of the&#xD;
             types of applications described below:&#xD;
&#xD;
               -  Deep interstitial application: anal canal, vagina, vulva&#xD;
&#xD;
               -  Gynecological application: mold, Utrecht® system or Venezia® system&#xD;
&#xD;
          -  Ability to provide written informed consent&#xD;
&#xD;
          -  Patients affiliated to the social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor and patients over 80 years old&#xD;
&#xD;
          -  Patients with major hearing loss&#xD;
&#xD;
          -  Patients who had recent ocular surgery with oculiare gas injection.&#xD;
&#xD;
          -  Patients suffering from psychotic disorders, and dementias.&#xD;
&#xD;
          -  Patients who do not understand the French language&#xD;
&#xD;
          -  Patients under guardianship or deprived of liberty&#xD;
&#xD;
          -  Patients with a contraindication to the administration of KALINOX®&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sophie RENARD, Md</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut de Cancérologie de Lorraine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut de Cancérologie de Lorraine</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <zip>54519</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>December 16, 2022</last_update_submitted>
  <last_update_submitted_qc>December 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>hypnosis</keyword>
  <keyword>care management</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/NCT03755895
org study id: 2018-004527-37
nct id: NCT03755895
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Formal hypnosis is a non-drug technique known to decrease anxiety and pain during the
      preoperative procedure.

      In brachytherapy, the practice of hypnosis has been shown to be feasible and beneficial for
      patients treated for prostate cancer The goal of the study is to demonstrate the added value
      of hypnosis during a brachytherapy detachment by improving the comfort of the patient.

      The investigators want to evaluate the contribution of hypnosis during brachytherapy
      detachment by quantifying the anxiety and pain felt by the patient during the procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Anxiety evaluation
time frame: 1day
description: The patient's anxiety will be assessed using the State-Trait Anxiety Inventory scale ("state of anxiety") before premedication (in the bedroom) and immediately after the brachytherapy detachment (in the examination room) during brachytherapy detachment using two care management: standard care versus standard care with formal hypnosis. The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety (Spielberger et al, 1983). The scale include 20 items. Higher scores indicate greater anxiety
measure: Pain evaluation: numeric scale
time frame: 1 day
description: Pain will be evaluated by a numeric scale before premedication (in the room), just before and just after the brachytherapy detachment (in the examination room). Patient inform their level of pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain
measure: Anxiety evaluation
time frame: 1 day
description: Anxiety will be evaluated by a numeric scale just before and just after the brachytherapy detachment. Patient inform their level of anxiety from 0 to 10 (11 point scale) with the understanding that 0 is equal to no anxiety and 10 is equal to worst possible anxiety
measure: Patient's perception of the care
time frame: 1day
description: The patient's perception of the care will be evaluated by a semi-directive phone interview conducted by the medical staff between day 3 and day 5 after the brachytherapy detachment
measure: Time of brachytherapy detachment
time frame: 1day
description: The time of brachytherapy detachment will be noted from the entrance to the patient's examination room until the end of the brachytherapy detachment
measure: Realization of the brachytherapy detachment
time frame: 1day
description: The ease of realization of the brachytherapy detachment and the comfort of the medical staff will be evaluated by an numeric scale at the end of the care and by a self-survey
arm group label: experimental
arm group type: Experimental
description: patients to benefit from brachytherapy detachment under KALINOX and formal hypnosis
arm group label: active comparator
arm group type: Active Comparator
description: patients to benefit from brachytherapy detachment under KALINOX
intervention type: Other
intervention name: formal hypnosis
description: patients will have brachytherapy detachment under Kalinox and formal hypnosis
arm group label: experimental
intervention type: Drug
intervention name: Kalinox
description: patients will have brachytherapy detachment under Kalinox
arm group label: active comparator
arm group label: experimental
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Sophie RENARD, Md
role: Principal Investigator
affiliation: Institut de Cancérologie de Lorraine
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No