<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/NCT02237976</url>
  </required_header>
  <id_info>
    <org_study_id>2014/47</org_study_id>
    <secondary_id>2014-A00538-39</secondary_id>
    <nct_id>NCT02237976</nct_id>
  </id_info>
  <brief_title>Self-hypnosis in Patients Awaiting Lung Transplantation</brief_title>
  <acronym>SelfHypTp</acronym>
  <official_title>Interest of Learning Self-hypnosis in Patients Awaiting Lung Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study is designed to utilize a self-hypnosis training program for patients&#xD;
      awaiting lung transplantation. This technique can increase their well being, particularly by&#xD;
      decreasing postoperative pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2014</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">April 26, 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain after lung transplantation</measure>
    <time_frame>one month</time_frame>
    <description>Mean pain score in the 48 hours preceding the consultation performed one month after lung transplantation. Pain score is determined by the patient on a visual analogue scale (VAS) .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain before and after lung transplantation</measure>
    <time_frame>6 months</time_frame>
    <description>Pain score is determined by the patient on a visual analogue scale (VAS) at the time of inscription on waiting list for transplantation, at the 8th day post transplantation, one and four months after transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>6 months</time_frame>
    <description>Anxiety is determined by the patient on a visual analogue scale (VAS) at the time of inscription on waiting list for transplantation, at the 8th day post transplantation, one and four months after transplantation.&#xD;
Anxiety is also determined by&#xD;
the State Anxiety Inventory and the Trait Anxiety Inventory at the time of inscription on waiting list for transplantation,&#xD;
the State Anxiety Inventory one and four months after transplantation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coping</measure>
    <time_frame>6 months</time_frame>
    <description>Coping is determined by the patient (Coping Strategies Questionnaire) at the time of inscription on waiting list for transplantation, and four months after transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catastrophism</measure>
    <time_frame>6 months</time_frame>
    <description>Catastrophism is determined by the patient (Sullivan questionnaire) at the time of inscription on waiting list for transplantation, and four months after transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>Quality of life is determined by the patient (SF12 questionnaire) at the time of inscription on waiting list for transplantation, one and four months after transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life related to the procedure</measure>
    <time_frame>6 months</time_frame>
    <description>Quality of life related to the procedure is determined by the patient using a specific questionnaire (Ringsted et al. Pain-related impairment of daily activities after thoracic surgery: a questionnaire validation. The Clinical Journal of Pain 2013;29(9):791-799) four months after transplantation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Practice of self-hypnosis</measure>
    <time_frame>6 months</time_frame>
    <description>Practice of self-hypnosis is determined by the patient using a specific questionnaire at the 8th day post transplantation, one and four months after transplantation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced expiratory volume in one second</measure>
    <time_frame>6 months</time_frame>
    <description>Forced expiratory volume in one second is measured 4 months after transplantation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Lung Transplantation</condition>
  <arm_group>
    <arm_group_label>Self-hypnosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients are trained to practice self-hypnosis wen they are listed for lung transplantation. They are encourage to practice it before and after transplantation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine practice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>No specific intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-hypnosis</intervention_name>
    <arm_group_label>Self-hypnosis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Routine practice</intervention_name>
    <arm_group_label>Routine practice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients aged 15 years or more requiring lung transplantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who cannot participate in learning sessions of self-hypnosis for cultural ,&#xD;
             cognitive or environmental reasons&#xD;
&#xD;
          -  patients who have participated in only one learning self-hypnosis session before&#xD;
             transplantation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mireille Michel-Cherqui, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopital Foch</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Foch</name>
      <address>
        <city>Suresnes</city>
        <state>Hauts De Seine</state>
        <zip>92151</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>March 15, 2022</last_update_submitted>
  <last_update_submitted_qc>March 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02237976
org study id: 2014/47
secondary id: 2014-A00538-39
nct id: NCT02237976
lead sponsor: 
has dmc: No
The proposed study is designed to utilize a self-hypnosis training program for patients
      awaiting lung transplantation. This technique can increase their well being, particularly by
      decreasing postoperative pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain after lung transplantation
time frame: one month
description: Mean pain score in the 48 hours preceding the consultation performed one month after lung transplantation. Pain score is determined by the patient on a visual analogue scale (VAS) .
measure: Pain before and after lung transplantation
time frame: 6 months
description: Pain score is determined by the patient on a visual analogue scale (VAS) at the time of inscription on waiting list for transplantation, at the 8th day post transplantation, one and four months after transplantation
measure: Anxiety
time frame: 6 months
description: Anxiety is determined by the patient on a visual analogue scale (VAS) at the time of inscription on waiting list for transplantation, at the 8th day post transplantation, one and four months after transplantation.
Anxiety is also determined by
the State Anxiety Inventory and the Trait Anxiety Inventory at the time of inscription on waiting list for transplantation,
the State Anxiety Inventory one and four months after transplantation.
measure: Coping
time frame: 6 months
description: Coping is determined by the patient (Coping Strategies Questionnaire) at the time of inscription on waiting list for transplantation, and four months after transplantation
measure: Catastrophism
time frame: 6 months
description: Catastrophism is determined by the patient (Sullivan questionnaire) at the time of inscription on waiting list for transplantation, and four months after transplantation
measure: Quality of life
time frame: 6 months
description: Quality of life is determined by the patient (SF12 questionnaire) at the time of inscription on waiting list for transplantation, one and four months after transplantation
measure: Quality of life related to the procedure
time frame: 6 months
description: Quality of life related to the procedure is determined by the patient using a specific questionnaire (Ringsted et al. Pain-related impairment of daily activities after thoracic surgery: a questionnaire validation. The Clinical Journal of Pain 2013;29(9):791-799) four months after transplantation
measure: Practice of self-hypnosis
time frame: 6 months
description: Practice of self-hypnosis is determined by the patient using a specific questionnaire at the 8th day post transplantation, one and four months after transplantation.
measure: Forced expiratory volume in one second
time frame: 6 months
description: Forced expiratory volume in one second is measured 4 months after transplantation.
arm group label: Self-hypnosis
arm group type: Experimental
description: Patients are trained to practice self-hypnosis wen they are listed for lung transplantation. They are encourage to practice it before and after transplantation.
arm group label: Routine practice
arm group type: Active Comparator
description: No specific intervention
intervention type: Behavioral
intervention name: Self-hypnosis
arm group label: Self-hypnosis
intervention type: Behavioral
intervention name: Routine practice
arm group label: Routine practice
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Mireille Michel-Cherqui, MD
role: Principal Investigator
affiliation: Hopital Foch
facility: 
country: France
responsible party type: Sponsor