<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/NCT03261648</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/17-0033</org_study_id>
    <secondary_id>2017-A00511-52</secondary_id>
    <nct_id>NCT03261648</nct_id>
  </id_info>
  <brief_title>Anxiety of Patient and His Partner During Admission to Emergency Department</brief_title>
  <acronym>ANXURG</acronym>
  <official_title>Anxiety of Patient and His Partner During Admission to Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</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>
      Evaluate and compare the impact of partner's stress in the pain of the patient admitted in&#xD;
      the emergency department&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Admission to an emergency department is a major source of anxiety for the patient. Anxiety&#xD;
      plays not only a role in its emotional state but can also have consequences on the taking&#xD;
      care of the patient and especially on the analgesic procedure.&#xD;
&#xD;
      Since pain is one of the first causes of emergency admission, patient anxiety should not be&#xD;
      overlooked. In the emergency department, patient consults frequently, with his partner .&#xD;
      Anxiety can also affect the partner, which may affect the patient. No studies have yet&#xD;
      demonstrated this correlation.&#xD;
&#xD;
      This study will evaluate, the anxiety of both parties and show the presence or not of an&#xD;
      influence of the partner's anxiety on the patient using a standardized questionnaire, the&#xD;
      State-Trait Anxiety Inventory- form Y (STAI-Y).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 23, 2017</start_date>
  <completion_date type="Actual">July 6, 2017</completion_date>
  <primary_completion_date type="Actual">July 6, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Compare the anxiety of the patient with that of his partner</measure>
    <time_frame>day 1</time_frame>
    <description>The anxiety will be evaluated by the State-Trait-Anxiety Inventory (Forme Y) questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Study the link between the patient's and his partner's anxiety</measure>
    <time_frame>day 1</time_frame>
    <description>A corelation will be do between the score obtained by the patient and the score obtained by the partner at the STAI-Y questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the link between the patient's anxiety and the patient's pain</measure>
    <time_frame>day 1</time_frame>
    <description>The patient's pain will be evaluated orally asking to him to use a scale pain to 0 of 10</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Anxiety</condition>
  <condition>Emergencies</condition>
  <arm_group>
    <arm_group_label>hospitalized patient</arm_group_label>
    <description>100 patients will completed the 'State-Trait-Anxiety Inventory (Forme Y) questionnaire Patients will evaluated here pain answering to a pain level scale</description>
  </arm_group>
  <arm_group>
    <arm_group_label>partner of the hospitalized patient</arm_group_label>
    <description>100 partners will completed the State-Trait-Anxiety Inventory (Forme Y) questionnaire</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>State-Trait-Anxiety Inventory (Forme Y) questionnaire</intervention_name>
    <description>after admission in the emergency department, patient and his partner will completed STAI Y questionnaire.</description>
    <arm_group_label>hospitalized patient</arm_group_label>
    <arm_group_label>partner of the hospitalized patient</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pain level scale</intervention_name>
    <description>as usual caregiver will ask to the patient to evaluated his pain level with a scale of one to ten</description>
    <arm_group_label>hospitalized patient</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        people admited in the emergency department and his partner&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admission to emergency department accompanied by his partner (lives in concubinage&#xD;
             with the patient)&#xD;
&#xD;
          -  Nurse patient's classification score up or equal to 3, 4 or 5&#xD;
&#xD;
          -  Oral consent given to the inclusion by the patient and the partner&#xD;
&#xD;
          -  Patient and partner Francophone or with a good understanding of French&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient under a system of legal protection&#xD;
&#xD;
          -  Non-Communicating Patient and partner&#xD;
&#xD;
          -  Patient and partner unable to write&#xD;
&#xD;
          -  Refusal of patient or partner&#xD;
&#xD;
          -  Admission of the patient with shock treatment corresponding to the nurse patient's&#xD;
             classification score 1 and 2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vincent BOUNES, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Toulouse, Toulouse, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Toulouse</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</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>Emergencies</mesh_term>
    <mesh_term>Anxiety Disorders</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/NCT03261648
org study id: RC31/17-0033
secondary id: 2017-A00511-52
nct id: NCT03261648
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluate and compare the impact of partner's stress in the pain of the patient admitted in
      the emergency department
Admission to an emergency department is a major source of anxiety for the patient. Anxiety
      plays not only a role in its emotional state but can also have consequences on the taking
      care of the patient and especially on the analgesic procedure.

      Since pain is one of the first causes of emergency admission, patient anxiety should not be
      overlooked. In the emergency department, patient consults frequently, with his partner .
      Anxiety can also affect the partner, which may affect the patient. No studies have yet
      demonstrated this correlation.

      This study will evaluate, the anxiety of both parties and show the presence or not of an
      influence of the partner's anxiety on the patient using a standardized questionnaire, the
      State-Trait Anxiety Inventory- form Y (STAI-Y).
observational model: Other
time perspective: Prospective
measure: Compare the anxiety of the patient with that of his partner
time frame: day 1
description: The anxiety will be evaluated by the State-Trait-Anxiety Inventory (Forme Y) questionnaire
measure: Study the link between the patient's and his partner's anxiety
time frame: day 1
description: A corelation will be do between the score obtained by the patient and the score obtained by the partner at the STAI-Y questionnaire
measure: Evaluate the link between the patient's anxiety and the patient's pain
time frame: day 1
description: The patient's pain will be evaluated orally asking to him to use a scale pain to 0 of 10
arm group label: hospitalized patient
description: 100 patients will completed the 'State-Trait-Anxiety Inventory (Forme Y) questionnaire Patients will evaluated here pain answering to a pain level scale
arm group label: partner of the hospitalized patient
description: 100 partners will completed the State-Trait-Anxiety Inventory (Forme Y) questionnaire
intervention type: Other
intervention name: State-Trait-Anxiety Inventory (Forme Y) questionnaire
description: after admission in the emergency department, patient and his partner will completed STAI Y questionnaire.
arm group label: hospitalized patient
arm group label: partner of the hospitalized patient
intervention type: Other
intervention name: pain level scale
description: as usual caregiver will ask to the patient to evaluated his pain level with a scale of one to ten
arm group label: hospitalized patient
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Vincent BOUNES, MD
role: Principal Investigator
affiliation: University Hospital of Toulouse, Toulouse, France
facility: 
country: France
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Anxiety Disorders