<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/NCT04399850</url>
  </required_header>
  <id_info>
    <org_study_id>APHP191042</org_study_id>
    <nct_id>NCT04399850</nct_id>
  </id_info>
  <brief_title>Impact of Hypnosis During Invasive Procedure in Intensive Care Unit</brief_title>
  <acronym>HYPNOICU</acronym>
  <official_title>Impact of Hypnosis During Invasive Procedure in Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      Pain during ICU stay remains one of the major complaints for patients. Beside pain intensity,&#xD;
      well described by patients' self reports, pain distress, which is an emotional experience,&#xD;
      cannot be treated with usual analgesia. The aim of the study is to analyze the impact of&#xD;
      hypnosis on pain intensity and distress on short and long term outcomes in non-sedated ICU&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 28, 2020</start_date>
  <completion_date type="Anticipated">December 18, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 28, 2021</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain distress</measure>
    <time_frame>within the before and the first hour after the procedure</time_frame>
    <description>Pain distress change in the hypnosis group measured before and within the first hour after the procedure.&#xD;
Pain distress will be assessed using Numeric rating scale, which goes from 0 (no pain stress) to 10 (maximum pain stress).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain intensity</measure>
    <time_frame>within first hour and first 24 hours after procedure</time_frame>
    <description>Pain intensity will be assessed using Numeric rating scale, which goes from 0 (no pain) to 10 (maximum pain imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adverse events</measure>
    <time_frame>during procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of each painful procedure</measure>
    <time_frame>up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesia dose</measure>
    <time_frame>within first and 24 hours after procedure</time_frame>
    <description>The dose of each analgesia treatment received by the patient will be collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of analgesia</measure>
    <time_frame>within first and 24 hours after procedure</time_frame>
    <description>The type of each analgesia treatment received by the patient will be collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>within first and 24 hours after procedure</time_frame>
    <description>Anxiety within first and 24 hours after procedure will be assessed using Numeric rating scale, which goes from 0 (no anxiety) to 10 (maximum anxiety imaginable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression scale</measure>
    <time_frame>at 3 months</time_frame>
    <description>The HAD scale is a self-assessment scale for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic.&#xD;
HADS is a self-administered scale of 14 items which assessed levels of depression and anxiety, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales (sum of the 7 items, ranging from 0 to 21). A higher score indicates worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post traumatic stress disorder assessed using Impact of Event Scale Revisited (IES R)</measure>
    <time_frame>at 3 months</time_frame>
    <description>The IES-R is a 22-item self-report measure (for DSM-IV) that assesses subjective distress caused by traumatic events. Items are rated on a 5-point scale ranging from 0 to 4 . The IES-R yields a total score (ranging from 0 to 88)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who had hypnosis transe</measure>
    <time_frame>during procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the experience of hypnosis</measure>
    <time_frame>at 3 months</time_frame>
    <description>Qualitative analysis of the experience of hypnosis will be performed using the semi-structured interview</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">124</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Patients who receive hypnosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who receive hypnosis during procedure by experiment physician</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patient with conventional pain management</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hypnosis group</intervention_name>
    <description>Patients who receive hypnosis</description>
    <arm_group_label>Patients who receive hypnosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients aged 18 years and older&#xD;
&#xD;
          -  ICU hospitalisation&#xD;
&#xD;
          -  Non-sedated patients who need an invasive procedure (Invasive procedures are defined&#xD;
             as chest tube (insert or remove), fibroscopy, catheter insert, lumbar punction and&#xD;
             bone marrow aspiration)&#xD;
&#xD;
          -  Physician experienced in hypnosis available&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  health insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  sedation and intubation, delirium, end-of-life decision,&#xD;
&#xD;
          -  deaf patient,&#xD;
&#xD;
          -  patient who does not understand French language,&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  patient under guardianship or curatorship&#xD;
&#xD;
          -  lack of health insurance&#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_contact>
    <last_name>Virginie Lemiale</last_name>
    <phone>+331 42 49 94 19</phone>
    <email>virgnie.lemiale@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Matthieu RESCHE-RIGON</last_name>
    <phone>0142499742</phone>
    <phone_ext>0142499742</phone_ext>
    <email>matthieu.resche-rigon@univ-paris-diderot.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital Saint-Louis</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Virginie Lemiale</last_name>
      <phone>+331 42 49 94 19</phone>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>April 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>June 23, 2021</last_update_submitted>
  <last_update_submitted_qc>June 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>invasive procedure</keyword>
  <keyword>pain distress</keyword>
  <keyword>hypnosis</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04399850
org study id: APHP191042
nct id: NCT04399850
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pain during ICU stay remains one of the major complaints for patients. Beside pain intensity,
      well described by patients' self reports, pain distress, which is an emotional experience,
      cannot be treated with usual analgesia. The aim of the study is to analyze the impact of
      hypnosis on pain intensity and distress on short and long term outcomes in non-sedated ICU
      patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Pain distress
time frame: within the before and the first hour after the procedure
description: Pain distress change in the hypnosis group measured before and within the first hour after the procedure.
Pain distress will be assessed using Numeric rating scale, which goes from 0 (no pain stress) to 10 (maximum pain stress).
measure: Pain intensity
time frame: within first hour and first 24 hours after procedure
description: Pain intensity will be assessed using Numeric rating scale, which goes from 0 (no pain) to 10 (maximum pain imaginable).
measure: Number of adverse events
time frame: during procedure
measure: Length of each painful procedure
time frame: up to 3 months
measure: Analgesia dose
time frame: within first and 24 hours after procedure
description: The dose of each analgesia treatment received by the patient will be collected.
measure: Type of analgesia
time frame: within first and 24 hours after procedure
description: The type of each analgesia treatment received by the patient will be collected.
measure: Anxiety
time frame: within first and 24 hours after procedure
description: Anxiety within first and 24 hours after procedure will be assessed using Numeric rating scale, which goes from 0 (no anxiety) to 10 (maximum anxiety imaginable).
measure: Hospital Anxiety and Depression scale
time frame: at 3 months
description: The HAD scale is a self-assessment scale for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic.
HADS is a self-administered scale of 14 items which assessed levels of depression and anxiety, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales (sum of the 7 items, ranging from 0 to 21). A higher score indicates worse outcome.
measure: Post traumatic stress disorder assessed using Impact of Event Scale Revisited (IES R)
time frame: at 3 months
description: The IES-R is a 22-item self-report measure (for DSM-IV) that assesses subjective distress caused by traumatic events. Items are rated on a 5-point scale ranging from 0 to 4 . The IES-R yields a total score (ranging from 0 to 88)
measure: Proportion of patients who had hypnosis transe
time frame: during procedure
measure: Description of the experience of hypnosis
time frame: at 3 months
description: Qualitative analysis of the experience of hypnosis will be performed using the semi-structured interview
arm group label: Patients who receive hypnosis
arm group type: Experimental
description: Patients who receive hypnosis during procedure by experiment physician
arm group label: Control arm
arm group type: No Intervention
description: Patient with conventional pain management
intervention type: Other
intervention name: Hypnosis group
description: Patients who receive hypnosis
arm group label: Patients who receive hypnosis
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Virginie Lemiale
phone: +331 42 49 94 19
email: virgnie.lemiale@aphp.fr
last name: Matthieu RESCHE-RIGON
phone: 0142499742
phone ext: 0142499742
email: matthieu.resche-rigon@univ-paris-diderot.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided