<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/NCT04483141</url>
  </required_header>
  <id_info>
    <org_study_id>RNI 2020 FERRIER</org_study_id>
    <secondary_id>2020-A01360-39</secondary_id>
    <nct_id>NCT04483141</nct_id>
  </id_info>
  <brief_title>Translation and Validation of the Abbey Pain Scale in Stroke Patients (ABBEY-F)</brief_title>
  <acronym>ABBEY-F</acronym>
  <official_title>Translation and Validation of the Abbey Pain Scale in Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</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>
      Pain is common after a stroke, affecting up to 49% of patients within 2 years of the event.&#xD;
      They include headache, musculoskeletal pain, spasticity and central neuropathic pain. A wide&#xD;
      range of patients have communication problems after stroke that make it difficult to assess&#xD;
      pain. Yet there is a major impact of pain on the quality of life of these patients. Some&#xD;
      tools have been validated to assess pain in non-communicative patients, but none are specific&#xD;
      to stroke patients. The Algoplus scale is commonly used in intra-hospital care in France. The&#xD;
      Abbey Pain Scale is not translated into French, and could provide a more accurate pain rating&#xD;
      for non-communicative patients.&#xD;
&#xD;
      The objective is to validate a French version of the Abbey Pain Scale for stroke patients.&#xD;
&#xD;
      It is an observational study with longitudinal data collection. It is planned to include 120&#xD;
      patients from the neurology department of the Clermont-Ferrand University Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted over a 12-month period. 120 patients hospitalized for stroke&#xD;
      including 60 communicating and 60 non-communicating patients will be recruited.&#xD;
      Epidemiological data will be collected at enrollment, as well as an initial assessment using&#xD;
      the Abbey and Algoplus scales for non-communicating and communicating patients, and also the&#xD;
      numerical scale for communicating patients. The HADS questionnaire will be completed by&#xD;
      communicating patients only. Of the 60 patients in each group, 30 will receive a second&#xD;
      concurrent assessment by an inter-rater, 30 will receive a test/retest reassessment after 30&#xD;
      minutes, and 20 will be reassessed 90 minutes later by the same scales after pain treatment.&#xD;
      For 30 of the 120 patients, an infrared pupillometry measurement will be performed before and&#xD;
      after treatment of acute pain. All patients will be recruited from the neurovascular unit of&#xD;
      the Clermont-Ferrand University Hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 10, 2021</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">May 2022</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>Abbey Pain Hetero-Evaluation Scale</measure>
    <time_frame>day 0</time_frame>
    <description>This scale searches for elements suggestive of pain in the patient by scoring between 0 (absent) and 3 (severe) each of the items: vocalization, facial expression, body language, physiological modifications, physical modifications; obtaining a score between 0 and 18.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety Depression Scale (HADS) Questionnaire</measure>
    <time_frame>day 0</time_frame>
    <description>This scale is an instrument to screen for anxiety and depressive disorders. It consists of 14 items rated from 0 to 3. Seven questions relate to the anxiety dimension (total A) and seven others to the depressive dimension (total D), giving 2 scores. for communicant patients only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Algoplus Pain Hetero-Evaluation Scale</measure>
    <time_frame>day 0</time_frame>
    <description>This scale searches for elements suggestive of pain in the patient by answering YES/NO to each of the items: face, gaze, complaints, body, and behaviour; score between 0 and 5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numerical Scale</measure>
    <time_frame>day 0</time_frame>
    <description>This is a communicant patient's self-assessment of the intensity of pain felt, between 0 (no pain) and 10 (maximum pain). for communicant patients only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infrared pupillometry measurement</measure>
    <time_frame>day 0 before treatment of acute pain</time_frame>
    <description>It is an absolute measurement of pupil size using a portable pupillometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infrared pupillometry measurement</measure>
    <time_frame>day 0 after treatment of acute pain</time_frame>
    <description>It is an absolute measurement of pupil size using a portable pupillometer</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Stroke</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>non-communicant stroke patients</arm_group_label>
    <description>Patients suffering from stroke, and unable to efficient communication. They will be assessed for pain through several tools (hetero-assessment of pain).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>communicant stroke patients</arm_group_label>
    <description>Patients suffering from stroke, and unable to efficient communication. They will be assessed for pain through several tools (including hetero-assessment and auto-assessment of pain)</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Abbey Pain Scale</intervention_name>
    <description>Hetero-assessment of pain</description>
    <arm_group_label>communicant stroke patients</arm_group_label>
    <arm_group_label>non-communicant stroke patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients hospitalized in the Neurovascular Unit for the management of ischemic stroke with&#xD;
        or without reperfusion treatment, or hemorrhagic stroke&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least 18 years old ;&#xD;
&#xD;
          -  Covered by Social Security;&#xD;
&#xD;
          -  Hospitalized in the Neurovascular Unit for the management of ischemic stroke with or&#xD;
             without reperfusion treatment, or hemorrhagic stroke;&#xD;
&#xD;
          -  NIHSS score greater than 1;&#xD;
&#xD;
          -  For communicating patients: French mother tongue, or reading French without&#xD;
             assistance, and able to understand the objectives.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal ;&#xD;
&#xD;
          -  Legally protected patient&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Pre-stroke psychiatric or neurodevelopmental disorders;&#xD;
&#xD;
          -  Transient ischemic attack;&#xD;
&#xD;
          -  Specific strokes: Bithalamic, locked-in syndrome.&#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>Anna FERRIER</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lise LACLAUTRE</last_name>
    <phone>+33473754963</phone>
    <email>promo_interne_drci@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lise Laclautre</last_name>
      <phone>+33473754963</phone>
      <email>promo_interne_drci@chu-clermontferrand.fr</email>
    </contact>
    <investigator>
      <last_name>Anna FERRIER</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Xavier MOISSET</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nathalie BOURGEOIS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>May 10, 2021</last_update_submitted>
  <last_update_submitted_qc>May 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>pain</keyword>
  <keyword>aphasia</keyword>
  <keyword>Abbey pain scale</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT04483141
org study id: RNI 2020 FERRIER
secondary id: 2020-A01360-39
nct id: NCT04483141
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pain is common after a stroke, affecting up to 49% of patients within 2 years of the event.
      They include headache, musculoskeletal pain, spasticity and central neuropathic pain. A wide
      range of patients have communication problems after stroke that make it difficult to assess
      pain. Yet there is a major impact of pain on the quality of life of these patients. Some
      tools have been validated to assess pain in non-communicative patients, but none are specific
      to stroke patients. The Algoplus scale is commonly used in intra-hospital care in France. The
      Abbey Pain Scale is not translated into French, and could provide a more accurate pain rating
      for non-communicative patients.

      The objective is to validate a French version of the Abbey Pain Scale for stroke patients.

      It is an observational study with longitudinal data collection. It is planned to include 120
      patients from the neurology department of the Clermont-Ferrand University Hospital.
The study will be conducted over a 12-month period. 120 patients hospitalized for stroke
      including 60 communicating and 60 non-communicating patients will be recruited.
      Epidemiological data will be collected at enrollment, as well as an initial assessment using
      the Abbey and Algoplus scales for non-communicating and communicating patients, and also the
      numerical scale for communicating patients. The HADS questionnaire will be completed by
      communicating patients only. Of the 60 patients in each group, 30 will receive a second
      concurrent assessment by an inter-rater, 30 will receive a test/retest reassessment after 30
      minutes, and 20 will be reassessed 90 minutes later by the same scales after pain treatment.
      For 30 of the 120 patients, an infrared pupillometry measurement will be performed before and
      after treatment of acute pain. All patients will be recruited from the neurovascular unit of
      the Clermont-Ferrand University Hospital.
observational model: Cohort
time perspective: Prospective
measure: Abbey Pain Hetero-Evaluation Scale
time frame: day 0
description: This scale searches for elements suggestive of pain in the patient by scoring between 0 (absent) and 3 (severe) each of the items: vocalization, facial expression, body language, physiological modifications, physical modifications; obtaining a score between 0 and 18.
measure: Hospital Anxiety Depression Scale (HADS) Questionnaire
time frame: day 0
description: This scale is an instrument to screen for anxiety and depressive disorders. It consists of 14 items rated from 0 to 3. Seven questions relate to the anxiety dimension (total A) and seven others to the depressive dimension (total D), giving 2 scores. for communicant patients only
measure: Algoplus Pain Hetero-Evaluation Scale
time frame: day 0
description: This scale searches for elements suggestive of pain in the patient by answering YES/NO to each of the items: face, gaze, complaints, body, and behaviour; score between 0 and 5.
measure: Numerical Scale
time frame: day 0
description: This is a communicant patient's self-assessment of the intensity of pain felt, between 0 (no pain) and 10 (maximum pain). for communicant patients only
measure: Infrared pupillometry measurement
time frame: day 0 before treatment of acute pain
description: It is an absolute measurement of pupil size using a portable pupillometer
measure: Infrared pupillometry measurement
time frame: day 0 after treatment of acute pain
description: It is an absolute measurement of pupil size using a portable pupillometer
arm group label: non-communicant stroke patients
description: Patients suffering from stroke, and unable to efficient communication. They will be assessed for pain through several tools (hetero-assessment of pain).
arm group label: communicant stroke patients
description: Patients suffering from stroke, and unable to efficient communication. They will be assessed for pain through several tools (including hetero-assessment and auto-assessment of pain)
intervention type: Diagnostic Test
intervention name: Abbey Pain Scale
description: Hetero-assessment of pain
arm group label: communicant stroke patients
arm group label: non-communicant stroke patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anna FERRIER
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Lise LACLAUTRE
phone: +33473754963
email: promo_interne_drci@chu-clermontferrand.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Stroke