<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/NCT04478253</url>
  </required_header>
  <id_info>
    <org_study_id>2019-A02677-50</org_study_id>
    <nct_id>NCT04478253</nct_id>
  </id_info>
  <brief_title>Virtual Reality Hypnosis for Thoracic Drain Insertion</brief_title>
  <acronym>VeRHiTY</acronym>
  <official_title>Effect of the Use of HYPNO VR on Pain Experienced During Chest Drain Insertion in Resuscitation Vigilant Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GCS Ramsay Santé pour l'Enseignement et la Recherche</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GCS Ramsay Santé pour l'Enseignement et la Recherche</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>
      The main objective of this study is to evaluate, in vigilant resuscitation patients, the&#xD;
      effect of the use of HYPNO VR on the pain felt during the insertion of a thoracic drain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized, open-label, monocentric, prospective study of two parallel&#xD;
      groups of patients in whom a chest tube is to be inserted:&#xD;
&#xD;
        -  Group 1: Insertion of the drain according to the usual management protocol.&#xD;
&#xD;
        -  Group 2: Insertion of the drain according to the usual management protocol supplemented&#xD;
           by the use of a hypnosis software application (HYPNO-VR).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 23, 2020</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2022</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>
    <intervention_model_description>Randomized prospective monocentric open-label study on two parallel groups based on the use or non-use of a virtual reality device coupled with hypnosis software (HYPNO-VR) during the insertion of a chest tube.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity progression</measure>
    <time_frame>24 hours</time_frame>
    <description>The intensity of pain associated with chest drain insertion (difference between pain felt at the time of insertion and basal pain prior to the procedure) is the primary endpoint. This will be measured on a simple numerical scale Graduated from 0 (no pain) to 10 (worst pain imaginable). Basal pain will be assessed 15 min before drainage, then immediately after insertion and after 4h, 8h, 12h, 16h, 20h and 24h.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evolution of pain measured on a simple numerical scale over 24 hours</measure>
    <time_frame>24 hours</time_frame>
    <description>Evolution of pain over 24 hours measured on a simple numerical scale Graduated from 0 (no pain) to 10 (worst pain imaginable). Basal pain will be assessed 15 min before drainage, then immediately after insertion and after 4h, 8h, 12h, 16h, 20h and 24h.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain distress measured on a simple numerical scale during the procedure and evolution from basal state</measure>
    <time_frame>24 hours</time_frame>
    <description>Pain distress during the procedure and evolution from basal state. The patient will rate how much pain during the procedure was distressing or annoying on a simple numerical scale ranging from 0 (not at all) to 10 (very annoying or upsetting). It will be evaluated in the basal state 15 min before drainage, then immediately after insertion and after 24 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety level measured on a simple numerical scale and the State-trait Anxiety Inventory scale (STAI-Y scale) during the procedure and evolution from basal status</measure>
    <time_frame>24 hours</time_frame>
    <description>Anxiety level measured on a simple numerical scale graduated from 0 (no anxiety) to 10 (worst imaginable anxiety) and the State-trait Anxiety Inventory scale (STAI-Y scale) during the procedure and evolution from basal status. The simple numerical scale graded from 0 (no anxiety) to 10 (worst imaginable anxiety) will be evaluated in the basal state 15 min before drainage, then immediately after insertion and after 4h, 8h, 12h, 16h, 20h and 24h. The STAI-Y scale has 20 items evaluated from 1 to 4 according to its intensity (1= NO, 2 = rather NO, 3 = rather YES, 4 = YES) will be evaluated in the basal state 15 min before drainage then immediately after insertion and after 24 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of sleep quality simple numerical scale graduated from 0 (very bad) to 10 (very good) on the first night after insertion of the drain and evolution compared to usual sleep quality.</measure>
    <time_frame>24 hours</time_frame>
    <description>Evaluation of sleep quality measured on a simple numerical scale graduated from 0 (very bad) to 10 (very good) on the first night after insertion of the drain and evolution compared to usual sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug consumption during the 24 hours following the insertion of the drain: analgesics (paracetamol, Tramadol, Nefopam, Morphine), Bromazepam and Zopiclone.</measure>
    <time_frame>24 hours</time_frame>
    <description>Drug consumption during the 24 hours following the insertion of the drain: analgesics (paracetamol, Tramadol, Nefopam, Morphine), Bromazepam and Zopiclone.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Pneumopathy</condition>
  <arm_group>
    <arm_group_label>HypnoVR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Insertion of the drain according to the usual management protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HypnoVR</intervention_name>
    <description>Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR).</description>
    <arm_group_label>HypnoVR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient 18 years of age or older, having read and signed the consent form for&#xD;
             participation in the study&#xD;
&#xD;
          -  Patient admitted to intensive care whose state of health requires the insertion of a&#xD;
             thoracic drain according to the doctor in charge of the patient.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient under legal protection, guardianship or trusteeship&#xD;
&#xD;
          -  Pregnant or breastfeeding patient&#xD;
&#xD;
          -  Patient not affiliated to the French social security system&#xD;
&#xD;
          -  Hearing or visual disturbances contraindicating the use of virtual reality headphones&#xD;
&#xD;
          -  Inability to provide the subject with informed information and/or written informed&#xD;
             consent: dementia, psychosis, consciousness disorders, non-French speaking patient&#xD;
&#xD;
          -  Unbalanced epilepsy&#xD;
&#xD;
          -  Contraindication to local anaesthesia, one of the analgesics or sleeping pills used in&#xD;
             the protocol&#xD;
&#xD;
          -  Need for drainage in a life-threatening emergency (respiratory distress or compressive&#xD;
             pleural effusion)&#xD;
&#xD;
          -  Concurrent participation in other research or during a period of exclusion from&#xD;
             previous research&#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>Arnaud GALBOIS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Privé Claude Galien</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Arnaud GALBOIS, MD</last_name>
    <phone>01 69 39 15 53</phone>
    <phone_ext>33</phone_ext>
    <email>galbois@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michel MUSDAGI, MD</last_name>
    <email>musdagi.m@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital Privé Claude Galien</name>
      <address>
        <city>Quincy-sous-Sénart</city>
        <zip>91480</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arnaud GALBOIS, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Michel MUSDAGI, MD</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04478253
org study id: 2019-A02677-50
nct id: NCT04478253
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of this study is to evaluate, in vigilant resuscitation patients, the
      effect of the use of HYPNO VR on the pain felt during the insertion of a thoracic drain.
This is a prospective, randomized, open-label, monocentric, prospective study of two parallel
      groups of patients in whom a chest tube is to be inserted:

        -  Group 1: Insertion of the drain according to the usual management protocol.

        -  Group 2: Insertion of the drain according to the usual management protocol supplemented
           by the use of a hypnosis software application (HYPNO-VR).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized prospective monocentric open-label study on two parallel groups based on the use or non-use of a virtual reality device coupled with hypnosis software (HYPNO-VR) during the insertion of a chest tube.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Pain intensity progression
time frame: 24 hours
description: The intensity of pain associated with chest drain insertion (difference between pain felt at the time of insertion and basal pain prior to the procedure) is the primary endpoint. This will be measured on a simple numerical scale Graduated from 0 (no pain) to 10 (worst pain imaginable). Basal pain will be assessed 15 min before drainage, then immediately after insertion and after 4h, 8h, 12h, 16h, 20h and 24h.
measure: Evolution of pain measured on a simple numerical scale over 24 hours
time frame: 24 hours
description: Evolution of pain over 24 hours measured on a simple numerical scale Graduated from 0 (no pain) to 10 (worst pain imaginable). Basal pain will be assessed 15 min before drainage, then immediately after insertion and after 4h, 8h, 12h, 16h, 20h and 24h.
measure: Pain distress measured on a simple numerical scale during the procedure and evolution from basal state
time frame: 24 hours
description: Pain distress during the procedure and evolution from basal state. The patient will rate how much pain during the procedure was distressing or annoying on a simple numerical scale ranging from 0 (not at all) to 10 (very annoying or upsetting). It will be evaluated in the basal state 15 min before drainage, then immediately after insertion and after 24 hours.
measure: Anxiety level measured on a simple numerical scale and the State-trait Anxiety Inventory scale (STAI-Y scale) during the procedure and evolution from basal status
time frame: 24 hours
description: Anxiety level measured on a simple numerical scale graduated from 0 (no anxiety) to 10 (worst imaginable anxiety) and the State-trait Anxiety Inventory scale (STAI-Y scale) during the procedure and evolution from basal status. The simple numerical scale graded from 0 (no anxiety) to 10 (worst imaginable anxiety) will be evaluated in the basal state 15 min before drainage, then immediately after insertion and after 4h, 8h, 12h, 16h, 20h and 24h. The STAI-Y scale has 20 items evaluated from 1 to 4 according to its intensity (1= NO, 2 = rather NO, 3 = rather YES, 4 = YES) will be evaluated in the basal state 15 min before drainage then immediately after insertion and after 24 hours.
measure: Evaluation of sleep quality simple numerical scale graduated from 0 (very bad) to 10 (very good) on the first night after insertion of the drain and evolution compared to usual sleep quality.
time frame: 24 hours
description: Evaluation of sleep quality measured on a simple numerical scale graduated from 0 (very bad) to 10 (very good) on the first night after insertion of the drain and evolution compared to usual sleep quality.
measure: Drug consumption during the 24 hours following the insertion of the drain: analgesics (paracetamol, Tramadol, Nefopam, Morphine), Bromazepam and Zopiclone.
time frame: 24 hours
description: Drug consumption during the 24 hours following the insertion of the drain: analgesics (paracetamol, Tramadol, Nefopam, Morphine), Bromazepam and Zopiclone.
arm group label: HypnoVR
arm group type: Experimental
description: Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR).
arm group label: Usual care
arm group type: No Intervention
description: Insertion of the drain according to the usual management protocol
intervention type: Device
intervention name: HypnoVR
description: Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR).
arm group label: HypnoVR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Arnaud GALBOIS, MD
role: Principal Investigator
affiliation: Hôpital Privé Claude Galien
last name: Arnaud GALBOIS, MD
phone: 01 69 39 15 53
phone ext: 33
email: galbois@gmail.com
last name: Michel MUSDAGI, MD
email: musdagi.m@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Lung Diseases