xml: <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/NCT05967988</url>
    </required_header>
    <id_info>
      <org_study_id>CER-VD 2023-00867</org_study_id>
      <nct_id>NCT05967988</nct_id>
    </id_info>
    <brief_title>Atmospheric Projection in the Emergency Department</brief_title>
    <acronym>AERIAL-MED</acronym>
    <official_title>AtmosphEric pRojection for paIn and Anxiety reLated to Minor Medical Procedures in the Emergency Department: a Monocentric, Parallel, Randomized, Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Lausanne Hospitals</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Lausanne</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Lausanne Hospitals</source>
    <oversight_info>
      <has_dmc>Yes</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 goal of this clinical trial is to learn about the reduction of pain and anxiety during a&#xD;
        minor procedure in the emergency department on adult patients through the visualisation of&#xD;
        atmospheric projection as a distraction mean. The main question it aims to answer is :&#xD;
  &#xD;
        Can the atmospheric projection of a video reduce pain and anxiety in adult patients receiving&#xD;
        painful procedures in the emergency department ?&#xD;
  &#xD;
        Participants will look at an atmospheric projection (projection of a media on the walls and&#xD;
        roof around the patient) while receiving their planned care procedures. Researchers will&#xD;
        compare an active group watching a video with a control group watching a simple colored light&#xD;
        to see if the visualisation of an atmospheric projected video reduces pain and anxiety more&#xD;
        than the visualisation of a colored light does.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 14, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</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>Single (Participant)</masking>
      <masking_description>The patient will assess the outcome him/herself. The statistician will also be blinded to the group assignment.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Procedural Pain</measure>
      <time_frame>Just after the procedure</time_frame>
      <description>Maximal pain intensity experienced by the patient during the medical procedure, assessed using a Visual Analogic Scale from 0mm to 100mm anchored with &quot;No pain/Worst pain imaginable&quot;</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Procedural Anxiety</measure>
      <time_frame>Just after the procedure</time_frame>
      <description>Maximal anxiety intensity felt by the patient during the medical procedure, assessed using a Visual Analogic Scale from 0mm to 100mm anchored with &quot;Not at all anxious/Extremely anxious.&quot;</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Telepresence</measure>
      <time_frame>Just after the procedure</time_frame>
      <description>Telepresence will be assessed by the Igroupe Presence Questionnaire composed of 14 statements grouped into 4 categories: (1) spatial presence (the sense of being physically present in the virtual environment), (2) involvement (attention devoted to the virtual environment and experienced involvement), (3) experienced realism (the subjective experience of realism in the virtual environment), and (4) the general sense of being in the virtual environment. Each question is rated on a 7-point scale (0 to 6), with greater scores indicating a greater sense of presence in the projected environment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dissociation</measure>
      <time_frame>Just after the procedure</time_frame>
      <description>Dissociation of the patients represents the mental separation of the patient from their environment, assessed using a Visual Analogic Scale from 0mm to 100mm, anchored with &quot;most present in the clinical environment / the most immersed in the projected environment &quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Appreciation of the atmospheric projection</measure>
      <time_frame>Just after the procedure</time_frame>
      <description>Appreciation of the atmospheric projection by the patient, using a Visual Analogic Scale from 0mm to 100mm, anchored with &quot;least appreciative/most appreciative)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient's comfort</measure>
      <time_frame>Just after the procedure</time_frame>
      <description>Patient's comfort during the atmospheric projection, assessed using a Visual Analogic Scale from 0mm to 100mm, anchored with &quot;least comfortable /most comfortable&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Procedural support</measure>
      <time_frame>After the procedure</time_frame>
      <description>Procedural support provided by the projection during the medical procedure according to the physician in charge of the procedure, assessed using a 3-level Likert scale (yes-neutral-no)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Procedural disturbance</measure>
      <time_frame>Just after the procedure</time_frame>
      <description>Procedural disturbance for physicians caused by the atmospheric projection interfering with the medical procedure, assessed using a 3-level Likert scale (yes-neutral-no)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cybercinetosis</measure>
      <time_frame>Just after the procedure</time_frame>
      <description>Cybercinetosis is a symptom similar to motion sickness that occurs with exposure to a virtual environment, will be assessed using a 3-level Likert scale (light-moderate-severe)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain catastrophizing</measure>
      <time_frame>Just before the procedure</time_frame>
      <description>Pain catastrophizing will be assessed using the French version of the Situational Catastrophizing Questionnaire, a 6-question adaptation of the Pain Catastrophizing Scale</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">140</enrollment>
    <condition>Pain, Acute</condition>
    <condition>Anxiety Acute</condition>
    <arm_group>
      <arm_group_label>Atmospheric 3D video projection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in the interventional arm will watch an immersive atmospheric video projection on the walls of their examination room.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Atmospheric 3D color projection</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Patients in the interventional arm will look at a neutral color of their choice projected on the walls of their examination room.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Immersive atmospheric projection</intervention_name>
      <description>Projection of computer-generated videos or videos of real moving landscapes on the walls of the examination room</description>
      <arm_group_label>Atmospheric 3D video projection</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Minimal atmospheric projection</intervention_name>
      <description>Projection of a colors on the walls on the walls of the examination room</description>
      <arm_group_label>Atmospheric 3D color projection</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged ≥18 ;&#xD;
  &#xD;
            -  Patient requiring one of the following treatment procedures : suturing, plaster cast&#xD;
               placement and/or repositioning, fracture or dislocation reduction, ascites puncture,&#xD;
               pleural puncture, lumbar puncture.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient clinically unstable;&#xD;
  &#xD;
            -  Patient incapable of discernment or consent ;&#xD;
  &#xD;
            -  Altered mental status (cognitive disorders, mental retardation, acute state of&#xD;
               confusion, acute psychosis);&#xD;
  &#xD;
            -  Alcoholic patient with University of California, San Diego Brief Assessment of&#xD;
               Capacity to Consent (UBACC) score of 10/10 ;&#xD;
  &#xD;
            -  Patient hard of hearing ;&#xD;
  &#xD;
            -  Patient with visual impairments preventing him/her from perceiving his/her environment&#xD;
               ;&#xD;
  &#xD;
            -  Patient unable to understand the use of visual analog scales (VAS);&#xD;
  &#xD;
            -  Impaired sensitivity of the part of the body where the medical intervention is to take&#xD;
               place;&#xD;
  &#xD;
            -  Planned use of analgesia/sedation with a dissociative agent (midazolam, ketamine,&#xD;
               propofol);&#xD;
  &#xD;
            -  Incarcerated patient ;&#xD;
  &#xD;
            -  Patient transferred from another hospital ;&#xD;
  &#xD;
            -  Patient having already participated in this study during a previous consultation in&#xD;
               the emergency department of the Centre Hospitalier Universitaire Vaudois.&#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>Olivier Hugli, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Lausanne Hospitals</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pr. Olivier Hugli, MPH</last_name>
      <phone>21 314 05</phone>
      <phone_ext>+41</phone_ext>
      <email>Olivier.Hugli@chuv.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Pr. Chantal Berna Renella, MD PHD</last_name>
      <phone>21 314 20 40</phone>
      <phone_ext>+41</phone_ext>
      <email>Chantal.Berna-Renella@chuv.ch</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 22, 2023</last_update_submitted>
    <last_update_submitted_qc>July 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Lausanne Hospitals</investigator_affiliation>
      <investigator_full_name>Olivier Hugli</investigator_full_name>
      <investigator_title>Head of Emergency Department</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Emergencies</mesh_term>
      <mesh_term>Acute Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05967988
  org study id: CER-VD 2023-00867
  nct id: NCT05967988
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to learn about the reduction of pain and anxiety during a
        minor procedure in the emergency department on adult patients through the visualisation of
        atmospheric projection as a distraction mean. The main question it aims to answer is :
  
        Can the atmospheric projection of a video reduce pain and anxiety in adult patients receiving
        painful procedures in the emergency department ?
  
        Participants will look at an atmospheric projection (projection of a media on the walls and
        roof around the patient) while receiving their planned care procedures. Researchers will
        compare an active group watching a video with a control group watching a simple colored light
        to see if the visualisation of an atmospheric projected video reduces pain and anxiety more
        than the visualisation of a colored light does.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: The patient will assess the outcome him/herself. The statistician will also be blinded to the group assignment.
  measure: Procedural Pain
  time frame: Just after the procedure
  description: Maximal pain intensity experienced by the patient during the medical procedure, assessed using a Visual Analogic Scale from 0mm to 100mm anchored with "No pain/Worst pain imaginable"
  measure: Procedural Anxiety
  time frame: Just after the procedure
  description: Maximal anxiety intensity felt by the patient during the medical procedure, assessed using a Visual Analogic Scale from 0mm to 100mm anchored with "Not at all anxious/Extremely anxious."
  measure: Telepresence
  time frame: Just after the procedure
  description: Telepresence will be assessed by the Igroupe Presence Questionnaire composed of 14 statements grouped into 4 categories: (1) spatial presence (the sense of being physically present in the virtual environment), (2) involvement (attention devoted to the virtual environment and experienced involvement), (3) experienced realism (the subjective experience of realism in the virtual environment), and (4) the general sense of being in the virtual environment. Each question is rated on a 7-point scale (0 to 6), with greater scores indicating a greater sense of presence in the projected environment
  measure: Dissociation
  time frame: Just after the procedure
  description: Dissociation of the patients represents the mental separation of the patient from their environment, assessed using a Visual Analogic Scale from 0mm to 100mm, anchored with "most present in the clinical environment / the most immersed in the projected environment "
  measure: Appreciation of the atmospheric projection
  time frame: Just after the procedure
  description: Appreciation of the atmospheric projection by the patient, using a Visual Analogic Scale from 0mm to 100mm, anchored with "least appreciative/most appreciative)
  measure: Patient's comfort
  time frame: Just after the procedure
  description: Patient's comfort during the atmospheric projection, assessed using a Visual Analogic Scale from 0mm to 100mm, anchored with "least comfortable /most comfortable"
  measure: Procedural support
  time frame: After the procedure
  description: Procedural support provided by the projection during the medical procedure according to the physician in charge of the procedure, assessed using a 3-level Likert scale (yes-neutral-no)
  measure: Procedural disturbance
  time frame: Just after the procedure
  description: Procedural disturbance for physicians caused by the atmospheric projection interfering with the medical procedure, assessed using a 3-level Likert scale (yes-neutral-no)
  measure: Cybercinetosis
  time frame: Just after the procedure
  description: Cybercinetosis is a symptom similar to motion sickness that occurs with exposure to a virtual environment, will be assessed using a 3-level Likert scale (light-moderate-severe)
  measure: Pain catastrophizing
  time frame: Just before the procedure
  description: Pain catastrophizing will be assessed using the French version of the Situational Catastrophizing Questionnaire, a 6-question adaptation of the Pain Catastrophizing Scale
  arm group label: Atmospheric 3D video projection
  arm group type: Experimental
  description: Patients in the interventional arm will watch an immersive atmospheric video projection on the walls of their examination room.
  arm group label: Atmospheric 3D color projection
  arm group type: Sham Comparator
  description: Patients in the interventional arm will look at a neutral color of their choice projected on the walls of their examination room.
  intervention type: Device
  intervention name: Immersive atmospheric projection
  description: Projection of computer-generated videos or videos of real moving landscapes on the walls of the examination room
  arm group label: Atmospheric 3D video projection
  intervention type: Device
  intervention name: Minimal atmospheric projection
  description: Projection of a colors on the walls on the walls of the examination room
  arm group label: Atmospheric 3D color projection
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Olivier Hugli, MD
  role: Principal Investigator
  affiliation: University of Lausanne Hospitals
  last name: Pr. Olivier Hugli, MPH
  phone: 21 314 05
  phone ext: +41
  email: Olivier.Hugli@chuv.ch
  last name: Pr. Chantal Berna Renella, MD PHD
  phone: 21 314 20 40
  phone ext: +41
  email: Chantal.Berna-Renella@chuv.ch
  responsible party type: Principal Investigator
  investigator affiliation: University of Lausanne Hospitals
  investigator full name: Olivier Hugli
  investigator title: Head of Emergency Department
  mesh term: Emergencies
  mesh term: Acute Pain
  sharing ipd: No