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/NCT05973201</url>
    </required_header>
    <id_info>
      <org_study_id>APHP220834</org_study_id>
      <secondary_id>2023-A00163-42</secondary_id>
      <secondary_id>PHRIP-21-0055</secondary_id>
      <nct_id>NCT05973201</nct_id>
    </id_info>
    <brief_title>Evaluation of Virtual Reality to Reduce Anxiety, Pain and Duration of Non-emergency Vigile Bronchial Fibroscopy</brief_title>
    <acronym>AVATAR</acronym>
    <official_title>Evaluation de la réalité Virtuelle Pour réduire l'anxiété, la Douleur et de la durée d'Une Fibroscopie Bronchique Vigile Non Urgente en Soins Critiques</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ministry of Health, France</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </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>
        Bronchial fibroscopy (BF) is a routine practice examination in critical care areas. It can be&#xD;
        useful either for the diagnosis of the causal pathology of respiratory distress or for the&#xD;
        diagnosis of lung infection, sometimes nosocomial. In patients in spontaneous and conscious&#xD;
        ventilation, BF are performed vigil after local anesthesia according to the recommendations&#xD;
        of the Société de Pneumologie de langue Française. The good tolerance of the examination and&#xD;
        its good conduct may require the use of anxiolytics, sedatives or analgesics to limit the&#xD;
        traumatic experience of a highly anxiety-provoking examination. Virtual reality (VR) combines&#xD;
        a set of paramedical techniques (hypnosis, music therapy, sophrology) and is now a non-drug&#xD;
        alternative to improve the tolerance of certain invasive gestures.VR has been shown to reduce&#xD;
        pain and anxiety during first pathways placement or digestive endoscopies. To date, there is&#xD;
        no evidence of the benefit of VR when performing semi-urgent BF in critical care areas.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Bronchial fibroscopy (BF) is an invasive examination mainly performed in vigilant patients&#xD;
        under local anesthesia very regularly performed in patients hospitalized in critical care.&#xD;
        Despite local anesthesia, and paradoxically also because of local anesthesia that makes the&#xD;
        airflow in the upper airway imperceptible, BF is an anxiety-provoking and sometimes&#xD;
        uncomfortable examination. Drug options are offered by physicians on a case-by-case basis and&#xD;
        in response to patients' discomfort or anxiety. We believe that a preventive, non-drug&#xD;
        strategy would improve comfort, reduce anxiety and improve patients' experience during BF. To&#xD;
        reduce anxiety and improve patient comfort, there are non-drug alternatives such as hypnosis,&#xD;
        music therapy or virtual reality. Hypnosis requires the availability of previously trained&#xD;
        caregivers and a calm environment. Music therapy is difficult to apply in IS because of&#xD;
        pre-existing noise pollution. We hypothesize that virtual reality would reduce patient&#xD;
        anxiety during a bronchial fibroscopy in bed in critical care, improve the patient and&#xD;
        caregiver experience and optimize its realization. Virtual reality (VR) is a technology that&#xD;
        allows the patient to be projected, via a computer system, into an immersive virtual world.&#xD;
        The patient's immersion in the virtual environment is accompanied by the feeling of&#xD;
        &quot;presence&quot; which can be defined as the authentic feeling of existing in a world other than&#xD;
        the one where the body is physically located.This specificity, coupled with the ability to&#xD;
        isolate the patient's visual and auditory field, make this tool a promising solution to&#xD;
        improve the well-being of patients during the care offer. VR is distributed by a set of&#xD;
        devices to digitally simulate an environment mobilizing the different senses of its user:&#xD;
        sight most often but possibly also touch, hearing or smell. VR, most often distributed via&#xD;
        video and audio headset, is a complete immersive experience that can bring together hypnotic&#xD;
        scenario and music therapy.&#xD;
  &#xD;
        HEALTHY MIND® has designed a VR headset to relieve pain and anxiety in patients in healthcare&#xD;
        facilities in a non-drug way. Indeed, this helmet has been developed to exercise analgesic&#xD;
        and anxiolytic actions through specific virtual environments by combining different&#xD;
        principles such as medical hypnosis, music therapy, light therapy and cardiac coherence. The&#xD;
        proposed immersion themes combined with breathing exercises in the initial phase, generate&#xD;
        better stress management.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 8, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2025</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>Patients in whom elective BF has been scheduled and who have given consent to the study will be randomised (1:1) to either the control group (BF after local anaesthesia (LA)) or the experimental group (BF after AL and VR immersion). Randomization will be done 30 minutes before BF, after an initial assessment of anxiety (pre-BF VAS) and will be stratified according to whether or not a psychotropic drug and/or a level II analgesic is taken the day before or on the day of BF.&#xD;
  The randomization list will be programmed in advance by the study statistician using SAS software and will be generated and edited by another statistician independent of the study from the HEGP clinical research unit. The randomization list will be kept by the study sponsor (AP-HP). It will be available to users via web-based software (CleanWeb software (Telemedicine Technologies, http: //www.tentelemed.com/la-solution-cleanweb/)].</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Maximum value of patient's anxiety experienced during BF assessed by the visual analogue scale (VAS) immediately after the BF</measure>
      <time_frame>Immediately after BF</time_frame>
      <description>The visual analogue scale is a rating scale in the form of a 10 cm strip graduated in mm that can be presented horizontally or vertically. On the face presented to the patient, there is a cursor that he mobilizes on a straight line with one end corresponding to &quot;absence of anxiety&quot; and the other to &quot;maximum anxiety imaginable&quot;. The patient must then place the cursor where he locates his anxiety. VAS ranges from 0 to 100 mm.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The relative change of patient's anxiety before and after BF assessed by the STAI-A scale (state anxiety scale)</measure>
      <time_frame>Immediately after BF</time_frame>
      <description>The Spielberger State-Trait Anxiety Inventory (STAI) is a 40-item self-report measure of anxiety using a 4-point Likert-type scale (from 1 to 4 points) for each item. It has two scales: State anxiety, i.e. how one feels at the moment; and Trait anxiety, i.e. how one generally feels. Both scales consist of 20 items. The state scale has 10 reverse-scored items, the trait scale has 7. Scores of both scales ranges from 20 to 80.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient's anxiety when leaving the intensive care unit (or on the 7th day at the latest, after BF) assessed by the visual analogue scale (VAS)</measure>
      <time_frame>When leaving the intensive care unit or on the 7th day at the latest, post BF</time_frame>
      <description>The visual analogue scale is a rating scale in the form of a 10 cm strip graduated in mm that can be presented horizontally or vertically. On the face presented to the patient, there is a cursor that he mobilizes on a straight line with one end corresponding to &quot;absence of anxiety&quot; and the other to &quot;maximum anxiety imaginable&quot;. The patient must then place the cursor where he locates his anxiety. VAS ranges from 0 to 100 mm.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient's anxiety experienced during BF evaluated by the nursing staff assessed by the COVI behavior and somatic complaints scales immediately after the FB</measure>
      <time_frame>Immediately after BF</time_frame>
      <description>The COVI scale consists of 3 items (subject's speech, behavior and somatic complaints) rated from 1 to 5 which assess speech, behavior and somatic complaints in anxious patients, with an overall score between 3 (no anxiety symptoms) and 15 (major anxiety). The behavior and somatic scales will be used.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum value of patient's pain experienced during BF assessed by the visual analogue scale (VAS) immediately after the FB</measure>
      <time_frame>Immediately after BF</time_frame>
      <description>The visual analogue scale is a rating scale in the form of a 10 cm strip graduated in mm that can be presented horizontally or vertically. On the face presented to the patient, there is a cursor that he mobilizes on a straight line with one end corresponding to &quot;absence of pain&quot; and the other to &quot;maximum pain imaginable&quot;. The patient must then place the cursor where he locates his pain. VAS ranges from 0 to 100 mm.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient's pain experienced during BF evaluated by the nursing staff assessed by the ALGOPLUS scale immediately after the FB</measure>
      <time_frame>Immediately after BF</time_frame>
      <description>The ALGOPLUS scale was specifically developed to evaluate and manage acute pain in the elderly in all situations in which reliable self-assessment is not feasible. The scale is composed of 5 items (observational areas/domains). Each item checked &quot;yes&quot; is accorded 1 point and the sum of checked items gives a total score ranging from 1 to 5.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The relative change of patient's maximum pulse measured during BF compared to pulse measured before BF</measure>
      <time_frame>Immediately after BF</time_frame>
      <description>The relative change of patient's maximum pulse measured during BF compared to pulse measured before BF</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The relative change of patient's maximum respiratory rate measured during BF compared to respiratory rate measured before BF</measure>
      <time_frame>Immediately after BF</time_frame>
      <description>The relative change of patient's maximum respiratory rate measured during BF compared to respiratory rate measured before BF</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The relative change of patient's maximum blood pressure measured during BF compared to blood pressure measured before BF</measure>
      <time_frame>Immediately after BF</time_frame>
      <description>The relative change of patient's maximum blood pressure measured during BF compared to blood pressure measured before BF</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The total dose of sedative and anxiolytic drugs prescribed during BF</measure>
      <time_frame>Immediately after BF</time_frame>
      <description>The total dose of midazolam, alprazolam, hydroxyzine, diprivan, stage II or III analgesics prescribed during BF</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The quality of the BF assessed by a specific questionnaire completed by the physician in charge of the BF</measure>
      <time_frame>Immediately after BF</time_frame>
      <description>A specific questionnaire completed by the physician in charge of the BF will be used describing the quality of the exploration and the possibility of taking samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The duration of BF (in minutes) from the start of the local anesthesia to the permanent removal of the fibroscopy</measure>
      <time_frame>Immediately after BF</time_frame>
      <description>The duration of BF (in minutes) from the start of the local anesthesia to the permanent removal of the fibroscopy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Remote patient's satisfaction on the BF procedure assessed 7 days post BF and measured by the e-SATIS questionnaire</measure>
      <time_frame>7 days post BF</time_frame>
      <description>E-SATIS is an experience and satisfaction questionnaire, in which all patients are invited to participate, following treatment in a health establishment, hospital or clinic. The questionnaire is validated by the French Haute autorité de santé. The &quot;patient care&quot; section of the questionnaire was used to assess remote patient's satisfaction on the BF procedure. For each responding patient, a score ranging from 1 [bad experience] to 5 [excellent experience] (transformed into a value from 0 to 100) is given to each of his answers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tolerance to the VR assessed by a questionnaire measuring the side effects of the VR</measure>
      <time_frame>1 day post BF</time_frame>
      <description>The questionnaire items lists the side effects of the VR (8 items with 3 answer categories: yes, no and do not know).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Respiratory Disorder</condition>
    <condition>Lung Infection</condition>
    <arm_group>
      <arm_group_label>interventional arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Fibroscopy performed under local anesthesia with immersion in a virtual reality scenario</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Conventional arm</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Fibroscopy performed under local anesthesia without immersion in a virtual reality scenario</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Virtual reality headset</intervention_name>
      <description>A HEALTHY MIND® brand VR headset is dedicated to the study. The kit includes a noise-reducing audio headset, a face mask diffusing the visual part, a touchscreen tablet connected to the two VR headset systems, and a microphone connected to the tablet.&#xD;
  The available software allows patients to choose between 5 natural environments in which a hypnotic speech is broadcast, available in several languages (French, English, Spanish, Russian, Arabic).</description>
      <arm_group_label>interventional arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults (over 18 years of age)&#xD;
  &#xD;
            -  Hospitalized in a critical care unit (intensive care and intensive care)&#xD;
  &#xD;
            -  Conscious (Glasgow score &gt;13)&#xD;
  &#xD;
            -  Spontaneous ventilation&#xD;
  &#xD;
            -  Requiring the realization of a FB&#xD;
  &#xD;
            -  First BF during hospitalization&#xD;
  &#xD;
            -  Having signed a consent to participate in the study&#xD;
  &#xD;
            -  Affiliation to social security&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-French-speaking patient&#xD;
  &#xD;
            -  Protected minors or adults who cannot consent to participate&#xD;
  &#xD;
            -  People with major neurocognitive impairment&#xD;
  &#xD;
            -  Patient refusing to participate in the study&#xD;
  &#xD;
            -  Patient on State medical aid&#xD;
  &#xD;
            -  Patient under guardianship or curatorship or under judicial protection&#xD;
  &#xD;
            -  BF for a vital emergency&#xD;
  &#xD;
            -  Prior inclusion in the study&#xD;
  &#xD;
            -  Pregnant or breastfeeding women&#xD;
  &#xD;
            -  Presence of a tracheostomy or tracheostomy&#xD;
  &#xD;
            -  Participation in other intervention research&#xD;
  &#xD;
            -  Epilepsy&#xD;
  &#xD;
            -  Visual impairment (blindness) or severe hearing impairment (hearing loss, deafness)&#xD;
               that does not allow the use of the helmet&#xD;
  &#xD;
            -  Psychiatric pathologies such as delusional disorders, hallucinations or schizophrenia.&#xD;
  &#xD;
            -  Autism spectrum disorders&#xD;
  &#xD;
            -  Patient sensitive to motion sickness&#xD;
  &#xD;
            -  Refractory migraine under treatment&#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>Anaïs RASTELLO, Nurse</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Aurélie ZINDJIRDJIAN</last_name>
      <phone>+331 44 84 17 64</phone>
      <email>aurelie.zindjirdjian@aphp.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sabrina BOUDIF</last_name>
      <phone>+331 56 09 29 20</phone>
      <email>sabrina.boudif@aphp.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CHI Aix en Provence</name>
        <address>
          <city>Aix-en-Provence</city>
          <zip>13100</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Youssef TRIGUI, MD</last_name>
        <phone>+334 42 33 90 33</phone>
        <email>ytrigui@ch-aix.fr</email>
      </contact>
      <investigator>
        <last_name>Youssef TRIGUI, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>CHU Dijon</name>
        <address>
          <city>Dijon</city>
          <zip>21079</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Marjolaine GEORGES, MD</last_name>
        <phone>+333 80 29 37 72</phone>
        <email>marjolaine.georges@chu-dijon.fr</email>
      </contact>
      <investigator>
        <last_name>Marjolaine GEORGES, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hôpital Le Kremlin Bicêtre</name>
        <address>
          <city>Le Kremlin-Bicêtre</city>
          <zip>94270</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Anne ROCHE, MD</last_name>
        <phone>+331 45 21 79 74</phone>
        <email>anne.roche@aphp.fr</email>
      </contact>
      <investigator>
        <last_name>Anne ROCHE, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hôpital européen Georges Pompidou - AP-HP</name>
        <address>
          <city>Paris</city>
          <zip>75015</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Anaïs RASTELLO, Nurse</last_name>
        <phone>+331 56 09 25 64</phone>
        <email>anais.rastello@aphp.fr</email>
      </contact>
      <investigator>
        <last_name>Anaïs RASTELLO, Nurse</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Virtual reality</keyword>
    <keyword>Pulmonary fibroscopy</keyword>
    <keyword>Anxiety</keyword>
    <keyword>Pain</keyword>
    <keyword>Intensive care</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiration Disorders</mesh_term>
      <mesh_term>Respiratory Tract Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>One year after the last publication</ipd_time_frame>
      <ipd_access_criteria>Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered.&#xD;
  Data sharing must respect agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization.&#xD;
  Processing of shared data must comply with European General Data Protection Regulation (GDPR)</ipd_access_criteria>
    </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/NCT05973201
  org study id: APHP220834
  secondary id: 2023-A00163-42
  secondary id: PHRIP-21-0055
  nct id: NCT05973201
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Bronchial fibroscopy (BF) is a routine practice examination in critical care areas. It can be
        useful either for the diagnosis of the causal pathology of respiratory distress or for the
        diagnosis of lung infection, sometimes nosocomial. In patients in spontaneous and conscious
        ventilation, BF are performed vigil after local anesthesia according to the recommendations
        of the Société de Pneumologie de langue Française. The good tolerance of the examination and
        its good conduct may require the use of anxiolytics, sedatives or analgesics to limit the
        traumatic experience of a highly anxiety-provoking examination. Virtual reality (VR) combines
        a set of paramedical techniques (hypnosis, music therapy, sophrology) and is now a non-drug
        alternative to improve the tolerance of certain invasive gestures.VR has been shown to reduce
        pain and anxiety during first pathways placement or digestive endoscopies. To date, there is
        no evidence of the benefit of VR when performing semi-urgent BF in critical care areas.
  Bronchial fibroscopy (BF) is an invasive examination mainly performed in vigilant patients
        under local anesthesia very regularly performed in patients hospitalized in critical care.
        Despite local anesthesia, and paradoxically also because of local anesthesia that makes the
        airflow in the upper airway imperceptible, BF is an anxiety-provoking and sometimes
        uncomfortable examination. Drug options are offered by physicians on a case-by-case basis and
        in response to patients' discomfort or anxiety. We believe that a preventive, non-drug
        strategy would improve comfort, reduce anxiety and improve patients' experience during BF. To
        reduce anxiety and improve patient comfort, there are non-drug alternatives such as hypnosis,
        music therapy or virtual reality. Hypnosis requires the availability of previously trained
        caregivers and a calm environment. Music therapy is difficult to apply in IS because of
        pre-existing noise pollution. We hypothesize that virtual reality would reduce patient
        anxiety during a bronchial fibroscopy in bed in critical care, improve the patient and
        caregiver experience and optimize its realization. Virtual reality (VR) is a technology that
        allows the patient to be projected, via a computer system, into an immersive virtual world.
        The patient's immersion in the virtual environment is accompanied by the feeling of
        "presence" which can be defined as the authentic feeling of existing in a world other than
        the one where the body is physically located.This specificity, coupled with the ability to
        isolate the patient's visual and auditory field, make this tool a promising solution to
        improve the well-being of patients during the care offer. VR is distributed by a set of
        devices to digitally simulate an environment mobilizing the different senses of its user:
        sight most often but possibly also touch, hearing or smell. VR, most often distributed via
        video and audio headset, is a complete immersive experience that can bring together hypnotic
        scenario and music therapy.
  
        HEALTHY MIND® has designed a VR headset to relieve pain and anxiety in patients in healthcare
        facilities in a non-drug way. Indeed, this helmet has been developed to exercise analgesic
        and anxiolytic actions through specific virtual environments by combining different
        principles such as medical hypnosis, music therapy, light therapy and cardiac coherence. The
        proposed immersion themes combined with breathing exercises in the initial phase, generate
        better stress management.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients in whom elective BF has been scheduled and who have given consent to the study will be randomised (1:1) to either the control group (BF after local anaesthesia (LA)) or the experimental group (BF after AL and VR immersion). Randomization will be done 30 minutes before BF, after an initial assessment of anxiety (pre-BF VAS) and will be stratified according to whether or not a psychotropic drug and/or a level II analgesic is taken the day before or on the day of BF.
  The randomization list will be programmed in advance by the study statistician using SAS software and will be generated and edited by another statistician independent of the study from the HEGP clinical research unit. The randomization list will be kept by the study sponsor (AP-HP). It will be available to users via web-based software (CleanWeb software (Telemedicine Technologies, http: //www.tentelemed.com/la-solution-cleanweb/)].
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Maximum value of patient's anxiety experienced during BF assessed by the visual analogue scale (VAS) immediately after the BF
  time frame: Immediately after BF
  description: The visual analogue scale is a rating scale in the form of a 10 cm strip graduated in mm that can be presented horizontally or vertically. On the face presented to the patient, there is a cursor that he mobilizes on a straight line with one end corresponding to "absence of anxiety" and the other to "maximum anxiety imaginable". The patient must then place the cursor where he locates his anxiety. VAS ranges from 0 to 100 mm.
  measure: The relative change of patient's anxiety before and after BF assessed by the STAI-A scale (state anxiety scale)
  time frame: Immediately after BF
  description: The Spielberger State-Trait Anxiety Inventory (STAI) is a 40-item self-report measure of anxiety using a 4-point Likert-type scale (from 1 to 4 points) for each item. It has two scales: State anxiety, i.e. how one feels at the moment; and Trait anxiety, i.e. how one generally feels. Both scales consist of 20 items. The state scale has 10 reverse-scored items, the trait scale has 7. Scores of both scales ranges from 20 to 80.
  measure: Patient's anxiety when leaving the intensive care unit (or on the 7th day at the latest, after BF) assessed by the visual analogue scale (VAS)
  time frame: When leaving the intensive care unit or on the 7th day at the latest, post BF
  description: The visual analogue scale is a rating scale in the form of a 10 cm strip graduated in mm that can be presented horizontally or vertically. On the face presented to the patient, there is a cursor that he mobilizes on a straight line with one end corresponding to "absence of anxiety" and the other to "maximum anxiety imaginable". The patient must then place the cursor where he locates his anxiety. VAS ranges from 0 to 100 mm.
  measure: Patient's anxiety experienced during BF evaluated by the nursing staff assessed by the COVI behavior and somatic complaints scales immediately after the FB
  time frame: Immediately after BF
  description: The COVI scale consists of 3 items (subject's speech, behavior and somatic complaints) rated from 1 to 5 which assess speech, behavior and somatic complaints in anxious patients, with an overall score between 3 (no anxiety symptoms) and 15 (major anxiety). The behavior and somatic scales will be used.
  measure: Maximum value of patient's pain experienced during BF assessed by the visual analogue scale (VAS) immediately after the FB
  time frame: Immediately after BF
  description: The visual analogue scale is a rating scale in the form of a 10 cm strip graduated in mm that can be presented horizontally or vertically. On the face presented to the patient, there is a cursor that he mobilizes on a straight line with one end corresponding to "absence of pain" and the other to "maximum pain imaginable". The patient must then place the cursor where he locates his pain. VAS ranges from 0 to 100 mm.
  measure: Patient's pain experienced during BF evaluated by the nursing staff assessed by the ALGOPLUS scale immediately after the FB
  time frame: Immediately after BF
  description: The ALGOPLUS scale was specifically developed to evaluate and manage acute pain in the elderly in all situations in which reliable self-assessment is not feasible. The scale is composed of 5 items (observational areas/domains). Each item checked "yes" is accorded 1 point and the sum of checked items gives a total score ranging from 1 to 5.
  measure: The relative change of patient's maximum pulse measured during BF compared to pulse measured before BF
  time frame: Immediately after BF
  description: The relative change of patient's maximum pulse measured during BF compared to pulse measured before BF
  measure: The relative change of patient's maximum respiratory rate measured during BF compared to respiratory rate measured before BF
  time frame: Immediately after BF
  description: The relative change of patient's maximum respiratory rate measured during BF compared to respiratory rate measured before BF
  measure: The relative change of patient's maximum blood pressure measured during BF compared to blood pressure measured before BF
  time frame: Immediately after BF
  description: The relative change of patient's maximum blood pressure measured during BF compared to blood pressure measured before BF
  measure: The total dose of sedative and anxiolytic drugs prescribed during BF
  time frame: Immediately after BF
  description: The total dose of midazolam, alprazolam, hydroxyzine, diprivan, stage II or III analgesics prescribed during BF
  measure: The quality of the BF assessed by a specific questionnaire completed by the physician in charge of the BF
  time frame: Immediately after BF
  description: A specific questionnaire completed by the physician in charge of the BF will be used describing the quality of the exploration and the possibility of taking samples
  measure: The duration of BF (in minutes) from the start of the local anesthesia to the permanent removal of the fibroscopy
  time frame: Immediately after BF
  description: The duration of BF (in minutes) from the start of the local anesthesia to the permanent removal of the fibroscopy
  measure: Remote patient's satisfaction on the BF procedure assessed 7 days post BF and measured by the e-SATIS questionnaire
  time frame: 7 days post BF
  description: E-SATIS is an experience and satisfaction questionnaire, in which all patients are invited to participate, following treatment in a health establishment, hospital or clinic. The questionnaire is validated by the French Haute autorité de santé. The "patient care" section of the questionnaire was used to assess remote patient's satisfaction on the BF procedure. For each responding patient, a score ranging from 1 [bad experience] to 5 [excellent experience] (transformed into a value from 0 to 100) is given to each of his answers.
  measure: Tolerance to the VR assessed by a questionnaire measuring the side effects of the VR
  time frame: 1 day post BF
  description: The questionnaire items lists the side effects of the VR (8 items with 3 answer categories: yes, no and do not know).
  arm group label: interventional arm
  arm group type: Experimental
  description: Fibroscopy performed under local anesthesia with immersion in a virtual reality scenario
  arm group label: Conventional arm
  arm group type: No Intervention
  description: Fibroscopy performed under local anesthesia without immersion in a virtual reality scenario
  intervention type: Device
  intervention name: Virtual reality headset
  description: A HEALTHY MIND® brand VR headset is dedicated to the study. The kit includes a noise-reducing audio headset, a face mask diffusing the visual part, a touchscreen tablet connected to the two VR headset systems, and a microphone connected to the tablet.
  The available software allows patients to choose between 5 natural environments in which a hypnotic speech is broadcast, available in several languages (French, English, Spanish, Russian, Arabic).
  arm group label: interventional arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Anaïs RASTELLO, Nurse
  role: Principal Investigator
  affiliation: Assistance Publique - Hôpitaux de Paris
  last name: Aurélie ZINDJIRDJIAN
  phone: +331 44 84 17 64
  email: aurelie.zindjirdjian@aphp.fr
  last name: Sabrina BOUDIF
  phone: +331 56 09 29 20
  email: sabrina.boudif@aphp.fr
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  country: France
  responsible party type: Sponsor
  mesh term: Respiration Disorders
  mesh term: Respiratory Tract Diseases
  sharing ipd: Yes
  ipd description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: One year after the last publication
  ipd access criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered.
  Data sharing must respect agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization.
  Processing of shared data must comply with European General Data Protection Regulation (GDPR)