<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/NCT02977767</url>
  </required_header>
  <id_info>
    <org_study_id>2016/CHU/02</org_study_id>
    <nct_id>NCT02977767</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effect of Conversational Hypnosis When Changing Tracheal Cannula in Adult Patients</brief_title>
  <acronym>HYPNO-TRACH</acronym>
  <official_title>Evaluation of the Effect of Conversational Hypnosis When Changing Tracheal Cannula in Adult Patients: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de la Réunion</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de la Réunion</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>
      Tracheotomy is requested when upper aero-digestive tracts are obstructed. This obstruction&#xD;
      can have a tumour, infectious, inflammatory, traumatic or nervous origin. Most tracheotomy&#xD;
      surgeries are performed for tumour-induced obstruction. Tracheotomy allows the setting of a&#xD;
      respiratory flux thanks to a cannula and excludes the upper airways. The cannula is washed&#xD;
      every day from once to several times depending on the patient's secretions production and it&#xD;
      is usually replaced every week. The second replacement takes place about 10 days after&#xD;
      surgery. Patient education takes place at every replacement in order to empower him/her and&#xD;
      in consequence to increase living comfort. This empowerment is achieved at the 4th or 5th&#xD;
      replacement, at best. Because of the risks and complications related to tracheotomy and&#xD;
      because of the concerned vital function, the cannula replacement leads to anxiety especially&#xD;
      during the first replacements. Usual patient's anxiety management consists in reassuring the&#xD;
      patient during the replacement. In other situations, patients' anxiety management would be&#xD;
      drugs, however due to sedative and anxiolytic drugs' adverse events and to the need to&#xD;
      maintain optimal breathing, they are not used in first intention. Our choice is to use&#xD;
      conversational hypnosis during cannula replacement as it has already demonstrated interesting&#xD;
      effects in pain and anxiety. Conversational hypnosis does not present an induction phase like&#xD;
      in so-called hypnosis, it aims at leading the patient to perceive his/her world differently&#xD;
      with only a slight consciousness alteration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Once the informed consent form is signed and when the cannula replacement has to be&#xD;
      performed, conversational hypnosis session will start right from the patient's room entrance&#xD;
      and end when the nurse will come out. The care will consist in aspiration, cleaning and&#xD;
      finally replacement of the cannula. Adverse events are expected to be related to the cannula&#xD;
      replacement itself: patients will be followed-up during a maximum of 7 days with one&#xD;
      follow-up visit which will take place 2 hours after cannula replacement and a second one&#xD;
      which can take place from the day after the replacement up to just before the following&#xD;
      replacement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2018</start_date>
  <completion_date type="Anticipated">January 2019</completion_date>
  <primary_completion_date type="Anticipated">September 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to change the tracheal cannula using conversational hypnosis</measure>
    <time_frame>On the patient's scope, time measured from the moment the nurse says &quot;now we start&quot; according to the conversational hypnosis protocol to the time the new cannula is fixed around the patient's neck, assessed up to 1 hour (3600 seconds).</time_frame>
    <description>Once the written informed consent form is obtained, the tracheal cannula change to perform in the frame of the study can be performed. As the patient will be scoped, the time to change the cannula will be monitored: the nurse will use an indicator on the scope to mark the start of the cannula change (when the sentence &quot;now we start&quot; is pronounced according to the conversational hypnosis protocol) and an indicator is placed on the scope when the new cannula is fixed around the patient's neck. The time between the two indicators will be reported in the Case Report Form in seconds.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Tracheotomy</condition>
  <arm_group>
    <arm_group_label>Conversational hypnosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of conversational hypnosis during the tracheal cannula replacement</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conversational hypnosis</intervention_name>
    <description>Conversational hypnosis starts since the enter of the nurse in patient's room and last since the nurse leaves the room. Change of canula is performed under conversational hypnosis.</description>
    <arm_group_label>Conversational hypnosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients hospitalised in the Ear, Nose, Throat - specialties surgery department&#xD;
&#xD;
          -  aged of 18 years old and more&#xD;
&#xD;
          -  having a tracheotomy following an upper aero-digestive tracts obstruction&#xD;
&#xD;
          -  presenting a tracheal cannula which can be replaced by paramedical staff&#xD;
&#xD;
          -  able to communicate to give their consent&#xD;
&#xD;
          -  member or beneficiary of a social security assurance&#xD;
&#xD;
          -  having given a signed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients presenting a hearing loss (preventing from hearing properly the words&#xD;
             pronounced during conversational hypnosis)&#xD;
&#xD;
          -  who do not understand French&#xD;
&#xD;
          -  who are under curators/guardianship&#xD;
&#xD;
          -  presenting dementia&#xD;
&#xD;
          -  autonomous in their cannula replacement&#xD;
&#xD;
          -  having already participated in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daw-Horng WU, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU La Réunion</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christine JUHEL, PharmD, PhD</last_name>
    <phone>+262262359949</phone>
    <email>christine.juhel@chu-reunion.fr</email>
  </overall_contact>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>December 18, 2017</last_update_submitted>
  <last_update_submitted_qc>December 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02977767
org study id: 2016/CHU/02
nct id: NCT02977767
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Tracheotomy is requested when upper aero-digestive tracts are obstructed. This obstruction
      can have a tumour, infectious, inflammatory, traumatic or nervous origin. Most tracheotomy
      surgeries are performed for tumour-induced obstruction. Tracheotomy allows the setting of a
      respiratory flux thanks to a cannula and excludes the upper airways. The cannula is washed
      every day from once to several times depending on the patient's secretions production and it
      is usually replaced every week. The second replacement takes place about 10 days after
      surgery. Patient education takes place at every replacement in order to empower him/her and
      in consequence to increase living comfort. This empowerment is achieved at the 4th or 5th
      replacement, at best. Because of the risks and complications related to tracheotomy and
      because of the concerned vital function, the cannula replacement leads to anxiety especially
      during the first replacements. Usual patient's anxiety management consists in reassuring the
      patient during the replacement. In other situations, patients' anxiety management would be
      drugs, however due to sedative and anxiolytic drugs' adverse events and to the need to
      maintain optimal breathing, they are not used in first intention. Our choice is to use
      conversational hypnosis during cannula replacement as it has already demonstrated interesting
      effects in pain and anxiety. Conversational hypnosis does not present an induction phase like
      in so-called hypnosis, it aims at leading the patient to perceive his/her world differently
      with only a slight consciousness alteration.
Once the informed consent form is signed and when the cannula replacement has to be
      performed, conversational hypnosis session will start right from the patient's room entrance
      and end when the nurse will come out. The care will consist in aspiration, cleaning and
      finally replacement of the cannula. Adverse events are expected to be related to the cannula
      replacement itself: patients will be followed-up during a maximum of 7 days with one
      follow-up visit which will take place 2 hours after cannula replacement and a second one
      which can take place from the day after the replacement up to just before the following
      replacement.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Time to change the tracheal cannula using conversational hypnosis
time frame: On the patient's scope, time measured from the moment the nurse says "now we start" according to the conversational hypnosis protocol to the time the new cannula is fixed around the patient's neck, assessed up to 1 hour (3600 seconds).
description: Once the written informed consent form is obtained, the tracheal cannula change to perform in the frame of the study can be performed. As the patient will be scoped, the time to change the cannula will be monitored: the nurse will use an indicator on the scope to mark the start of the cannula change (when the sentence "now we start" is pronounced according to the conversational hypnosis protocol) and an indicator is placed on the scope when the new cannula is fixed around the patient's neck. The time between the two indicators will be reported in the Case Report Form in seconds.
arm group label: Conversational hypnosis
arm group type: Experimental
description: Use of conversational hypnosis during the tracheal cannula replacement
intervention type: Procedure
intervention name: Conversational hypnosis
description: Conversational hypnosis starts since the enter of the nurse in patient's room and last since the nurse leaves the room. Change of canula is performed under conversational hypnosis.
arm group label: Conversational hypnosis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daw-Horng WU, MD
role: Principal Investigator
affiliation: CHU La Réunion
last name: Christine JUHEL, PharmD, PhD
phone: +262262359949
email: christine.juhel@chu-reunion.fr
responsible party type: Sponsor
sharing ipd: No