<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/NCT02216539</url>
  </required_header>
  <id_info>
    <org_study_id>2014-A00538-39</org_study_id>
    <nct_id>NCT02216539</nct_id>
  </id_info>
  <brief_title>Interest of Learning Self-hypnosis for Patients Awaiting Lung Transplantation</brief_title>
  <acronym>AUTOHYPNOSE-TP</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Ophtalmologique Adolphe de Rothschild</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Ophtalmologique Adolphe de Rothschild</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients benefitting from a lung transplantation are subject to long-lasting and often severe&#xD;
      post-operative pain. Self-hypnosis has been proven effective in the management of acute pain.&#xD;
&#xD;
      The study hypothesis is that pre-operative training in self-hypnosis given to patients&#xD;
      awaiting lung transplantation, will result in a reduction of post-operative pain one month&#xD;
      after surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Change of sponsor&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Actual">December 2014</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>Average Pain Score (Visual Analog Scale) One Month After Surgery</measure>
    <time_frame>one month after transplantation</time_frame>
    <description>Average level of pain (scored by the patient on a visual analog scale), during the 48 hours preceding the scheduled consultation at one month post-surgery</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Lung Diseases</condition>
  <arm_group>
    <arm_group_label>Self-hypnosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients trained to self-hypnosis before surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual pain management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receiving the usual post-operative pain management protocols</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-hypnosis</intervention_name>
    <description>Patients will be trained to self-hypnosis prior to surgery, in order to be able to use self-hypnosis as a pain-management tool after surgery</description>
    <arm_group_label>Self-hypnosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lung transplantation</intervention_name>
    <arm_group_label>Self-hypnosis</arm_group_label>
    <arm_group_label>Usual pain management</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard post-operative pain management</intervention_name>
    <description>Post-operative pain management treatments as per usual protocols in the hospital</description>
    <arm_group_label>Self-hypnosis</arm_group_label>
    <arm_group_label>Usual pain management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients over 15 years of age&#xD;
&#xD;
          -  indication of lung transplantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient unable to receive training in self-hypnosis (for cognitive, linguistic or&#xD;
             cultural reasons)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mireille Michel-Cherqui, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Foch, Suresnes, France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marc Fischler, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hôpital Foch, Suresnes, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92151</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>May 12, 2016</last_update_submitted>
  <last_update_submitted_qc>May 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>All terminal</keyword>
  <keyword>leading</keyword>
  <keyword>indication</keyword>
  <keyword>lung transplantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung 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/NCT02216539
org study id: 2014-A00538-39
nct id: NCT02216539
lead sponsor: 
has dmc: Yes
Patients benefitting from a lung transplantation are subject to long-lasting and often severe
      post-operative pain. Self-hypnosis has been proven effective in the management of acute pain.

      The study hypothesis is that pre-operative training in self-hypnosis given to patients
      awaiting lung transplantation, will result in a reduction of post-operative pain one month
      after surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Average Pain Score (Visual Analog Scale) One Month After Surgery
time frame: one month after transplantation
description: Average level of pain (scored by the patient on a visual analog scale), during the 48 hours preceding the scheduled consultation at one month post-surgery
arm group label: Self-hypnosis
arm group type: Experimental
description: Patients trained to self-hypnosis before surgery
arm group label: Usual pain management
arm group type: Active Comparator
description: Patients receiving the usual post-operative pain management protocols
intervention type: Behavioral
intervention name: Self-hypnosis
description: Patients will be trained to self-hypnosis prior to surgery, in order to be able to use self-hypnosis as a pain-management tool after surgery
arm group label: Self-hypnosis
intervention type: Procedure
intervention name: Lung transplantation
arm group label: Self-hypnosis
arm group label: Usual pain management
intervention type: Other
intervention name: Standard post-operative pain management
description: Post-operative pain management treatments as per usual protocols in the hospital
arm group label: Self-hypnosis
arm group label: Usual pain management
criteria: 
gender: All
minimum age: 15 Years
maximum age: 90 Years
healthy volunteers: No
last name: Mireille Michel-Cherqui, MD
role: Principal Investigator
affiliation: Hôpital Foch, Suresnes, France
last name: Marc Fischler, MD
role: Study Chair
affiliation: Hôpital Foch, Suresnes, France
facility: 
country: France
responsible party type: Sponsor
mesh term: Lung Diseases