<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/NCT03266523</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2016/49</org_study_id>
    <nct_id>NCT03266523</nct_id>
  </id_info>
  <brief_title>Influence of Natural Images on Patients' Anxiety in the Waiting Rooms of Imaging Ward</brief_title>
  <acronym>VERTIM</acronym>
  <official_title>Pilot Study on the Influence of the Integration of Natural Images, According to Various Esthetic Approaches, in the Waiting Rooms of Imaging on the Anxiety Felt by the Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      VERTIM study aims to evaluate the influence of different environments of imaging waiting&#xD;
      rooms on the anxiety felt by patients before MRI or CT scans. For this, four environments&#xD;
      (neutral/standard; and nature &quot;green&quot;, &quot;sea&quot;, and &quot;zen&quot;) will be set up in MRI and CT waiting&#xD;
      rooms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each year, the Medical Imaging Unit of the University Hospital of Bordeaux (CHU Bordeaux)&#xD;
      receives 80,500 patients for CT or MRI scans in usual care. The length of waiting, the&#xD;
      environment of the waiting room, the reasons for the examination are factors that increase&#xD;
      the levels of anxiety during waiting and but also during early examination.&#xD;
&#xD;
      Previous studies have shown that the integration of nature (real as well as artificial) is&#xD;
      likely to decrease the level of anxiety. Before implementing a multicentre and randomised&#xD;
      trial, a pilot study is necessary to assess the feasibility of the procedure, to test the&#xD;
      relevance of the tools, to identify the influence of socio-cultural and socio-demographic&#xD;
      characteristics on anxiety's level.&#xD;
&#xD;
      For this, the present study will be conducted over the same period of the year in order to&#xD;
      avoid seasonality biases. The study will take place over 8 weeks, during which MRI or scanner&#xD;
      patients will be exposed either to the neutral environment (standard environment of the&#xD;
      waiting room) or to one of the 3 environments (wall posters representing the nature (&quot;green&quot;,&#xD;
      &quot;sea&quot;, &quot;zen&quot;)).&#xD;
&#xD;
      There is no specific intervention assigned to the study participants, i.e. the patients will&#xD;
      receive one of the four environments as part of routine medical care, and a researcher&#xD;
      studies the effect of this environment on anxiety's level. Every week, one environment will&#xD;
      be set up in the MRI or scanner waiting room and the study will be proposed to all eligible&#xD;
      patients present in this room. Fifty patients are expected each week so that 100 patients per&#xD;
      environment and equally distributed between the MRI and scanner waiting rooms are expected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Average of the scores of anxiety-State (STAI-Y).</measure>
    <time_frame>The day the patient waits in the imaging waiting room</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average of the scores of emotional perception for the various esthetic approaches</measure>
    <time_frame>The day the patient waits in the imaging waiting room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores of the anxiety-trait in each of the subgroups</measure>
    <time_frame>The day the patient waits in the imaging waiting room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores of satisfaction for the various esthetic approaches</measure>
    <time_frame>The day the patient waits in the imaging waiting room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength of the interaction between emotional perception *environnement to explain the level of anxiety State</measure>
    <time_frame>The day the patient waits in the imaging waiting room</time_frame>
    <description>This outcome is measured through the scores of emotional perception (emotional perception), the nature of environment applied (control, zen, green or sea) and the STAI-Y scale score (level of state anxiety)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reliability of the tool: coefficient alpha of Cronbach, or coefficient α ≥ 0,7.</measure>
    <time_frame>The day the patient waits in the imaging waiting room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reason for MRI or scanner's prescription</measure>
    <time_frame>The day the patient waits in the imaging waiting room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiolytic treatment and / or antidepressants (regular intake)</measure>
    <time_frame>The day the patient waits in the imaging waiting room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiolytic treatment (specific prescription for examination)</measure>
    <time_frame>The day the patient waits in the imaging waiting room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gender</measure>
    <time_frame>The day the patient waits in the imaging waiting room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>age</measure>
    <time_frame>The day the patient waits in the imaging waiting room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of education</measure>
    <time_frame>The day the patient waits in the imaging waiting room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>professional category</measure>
    <time_frame>The day the patient waits in the imaging waiting room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of housing</measure>
    <time_frame>The day the patient waits in the imaging waiting room</time_frame>
    <description>house or building, floor, elevator, garden, ...</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lifestyle</measure>
    <time_frame>The day the patient waits in the imaging waiting room</time_frame>
    <description>urban, rural</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">418</enrollment>
  <condition>All Conditions for Which a CT or MRI Exam Can be Required</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>The CONTROL (neutral) environment corresponds to the standard environment of the imaging waiting rooms</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Zen</arm_group_label>
    <description>The ZEN environment will represent a clean, minimalist nature</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Green</arm_group_label>
    <description>The GREEN environment will represent rural landscapes, undergrowth</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sea</arm_group_label>
    <description>The SEA environment will represent lakes, ponds, seaside</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Natural images in imaging waiting rooms</intervention_name>
    <description>Standard environment for hospital imaging waiting rooms</description>
    <arm_group_label>Green</arm_group_label>
    <arm_group_label>Sea</arm_group_label>
    <arm_group_label>Zen</arm_group_label>
    <other_name>Neutral</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The participants are major patients who will be present in the waiting room of the MRI or&#xD;
        the scanner in order to carry out one of these two exams&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient 18 yrs and older;&#xD;
&#xD;
          -  patients in MRI or scanner's waiting room awaiting one of these 2 exams;&#xD;
&#xD;
          -  patients not objecting to answer questionnaires;&#xD;
&#xD;
          -  patient covered under social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient &lt;18yrs old;&#xD;
&#xD;
          -  patients with hearing and visual impairments;&#xD;
&#xD;
          -  patients unable to answer questionnaires;&#xD;
&#xD;
          -  patients awaiting for other exams than MRI or scanner;&#xD;
&#xD;
          -  legally protected patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hopital Pellegrin</name>
      <address>
        <city>Bordeaux</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>July 12, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>December 26, 2017</last_update_submitted>
  <last_update_submitted_qc>December 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CT</keyword>
  <keyword>MRI</keyword>
  <keyword>Anxiety-state</keyword>
  <keyword>Anxiety State-Trait</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <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/NCT03266523
org study id: CHUBX 2016/49
nct id: NCT03266523
lead sponsor: 
has dmc: No
VERTIM study aims to evaluate the influence of different environments of imaging waiting
      rooms on the anxiety felt by patients before MRI or CT scans. For this, four environments
      (neutral/standard; and nature "green", "sea", and "zen") will be set up in MRI and CT waiting
      rooms.
Each year, the Medical Imaging Unit of the University Hospital of Bordeaux (CHU Bordeaux)
      receives 80,500 patients for CT or MRI scans in usual care. The length of waiting, the
      environment of the waiting room, the reasons for the examination are factors that increase
      the levels of anxiety during waiting and but also during early examination.

      Previous studies have shown that the integration of nature (real as well as artificial) is
      likely to decrease the level of anxiety. Before implementing a multicentre and randomised
      trial, a pilot study is necessary to assess the feasibility of the procedure, to test the
      relevance of the tools, to identify the influence of socio-cultural and socio-demographic
      characteristics on anxiety's level.

      For this, the present study will be conducted over the same period of the year in order to
      avoid seasonality biases. The study will take place over 8 weeks, during which MRI or scanner
      patients will be exposed either to the neutral environment (standard environment of the
      waiting room) or to one of the 3 environments (wall posters representing the nature ("green",
      "sea", "zen")).

      There is no specific intervention assigned to the study participants, i.e. the patients will
      receive one of the four environments as part of routine medical care, and a researcher
      studies the effect of this environment on anxiety's level. Every week, one environment will
      be set up in the MRI or scanner waiting room and the study will be proposed to all eligible
      patients present in this room. Fifty patients are expected each week so that 100 patients per
      environment and equally distributed between the MRI and scanner waiting rooms are expected.
observational model: Cohort
time perspective: Prospective
measure: Average of the scores of anxiety-State (STAI-Y).
time frame: The day the patient waits in the imaging waiting room
measure: Average of the scores of emotional perception for the various esthetic approaches
time frame: The day the patient waits in the imaging waiting room
measure: Scores of the anxiety-trait in each of the subgroups
time frame: The day the patient waits in the imaging waiting room
measure: Scores of satisfaction for the various esthetic approaches
time frame: The day the patient waits in the imaging waiting room
measure: Strength of the interaction between emotional perception *environnement to explain the level of anxiety State
time frame: The day the patient waits in the imaging waiting room
description: This outcome is measured through the scores of emotional perception (emotional perception), the nature of environment applied (control, zen, green or sea) and the STAI-Y scale score (level of state anxiety)
measure: Reliability of the tool: coefficient alpha of Cronbach, or coefficient α ≥ 0,7.
time frame: The day the patient waits in the imaging waiting room
measure: Reason for MRI or scanner's prescription
time frame: The day the patient waits in the imaging waiting room
measure: Anxiolytic treatment and / or antidepressants (regular intake)
time frame: The day the patient waits in the imaging waiting room
measure: Anxiolytic treatment (specific prescription for examination)
time frame: The day the patient waits in the imaging waiting room
measure: gender
time frame: The day the patient waits in the imaging waiting room
measure: age
time frame: The day the patient waits in the imaging waiting room
measure: Level of education
time frame: The day the patient waits in the imaging waiting room
measure: professional category
time frame: The day the patient waits in the imaging waiting room
measure: Type of housing
time frame: The day the patient waits in the imaging waiting room
description: house or building, floor, elevator, garden, ...
measure: Lifestyle
time frame: The day the patient waits in the imaging waiting room
description: urban, rural
arm group label: Control
description: The CONTROL (neutral) environment corresponds to the standard environment of the imaging waiting rooms
arm group label: Zen
description: The ZEN environment will represent a clean, minimalist nature
arm group label: Green
description: The GREEN environment will represent rural landscapes, undergrowth
arm group label: Sea
description: The SEA environment will represent lakes, ponds, seaside
intervention type: Other
intervention name: Natural images in imaging waiting rooms
description: Standard environment for hospital imaging waiting rooms
arm group label: Green
arm group label: Sea
arm group label: Zen
other name: Neutral
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Anxiety Disorders
sharing ipd: No