<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/NCT02975778</url>
  </required_header>
  <id_info>
    <org_study_id>2016/27</org_study_id>
    <secondary_id>2016-A00709-42</secondary_id>
    <nct_id>NCT02975778</nct_id>
  </id_info>
  <brief_title>Prediction of Pain During Old People Care Measured by Skin Conductance</brief_title>
  <acronym>DOLOAGE</acronym>
  <official_title>Prediction of Pain During Old People Care Measured by Skin Conductance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</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>
      The purpose of the project is to validate the use of Pain Monitor™ device, not invasive and&#xD;
      simple of employment, for old people able to answer to a digital scale of pain intensity.&#xD;
&#xD;
      The main objective is to develop and to validate a model of prediction of the pain in old&#xD;
      subject at the time of the care, using the measure of variation of the skin conductance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Budgetary and operational issues&#xD;
  </why_stopped>
  <start_date type="Actual">June 15, 2017</start_date>
  <completion_date type="Actual">March 19, 2018</completion_date>
  <primary_completion_date type="Actual">March 19, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between Number of pics of skin conductance per second measured by Pain Monitor™ device with Numerical visual scale score for pain</measure>
    <time_frame>14 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression (HAD) score</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of efficient poses of Pain Monitor</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patient refusal to use of the Pain monitor</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Aged, 65 and over</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pain Monitor™</intervention_name>
    <description>Pain measured by Pain Monitor™</description>
    <arm_group_label>Aged, 65 and over</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hospitalized patient;&#xD;
&#xD;
          -  patient over 65 years of age;&#xD;
&#xD;
          -  communicating, without cognitive impairment;&#xD;
&#xD;
          -  having to undergo an act presumed to be painful during which the patient's mobility is&#xD;
             limited: nursing care (removal of a drain, dressing of a chronic wound, urinary&#xD;
             catheterization, etc.), medical examination, etc.;&#xD;
&#xD;
          -  benefiting from a social security scheme or having rights;&#xD;
&#xD;
          -  having given their prior informed written consent;&#xD;
&#xD;
          -  person able to read.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cutaneous anomaly on the site of measure;&#xD;
&#xD;
          -  pacemaker or internal defibrillator;&#xD;
&#xD;
          -  extremities twitching;&#xD;
&#xD;
          -  Treated by neostigmine.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc Fischler, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hopital Foch</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maison Médicale Jeanne Garnier</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>March 5, 2021</last_update_submitted>
  <last_update_submitted_qc>March 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>65 years old</keyword>
  <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/NCT02975778
org study id: 2016/27
secondary id: 2016-A00709-42
nct id: NCT02975778
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the project is to validate the use of Pain Monitor™ device, not invasive and
      simple of employment, for old people able to answer to a digital scale of pain intensity.

      The main objective is to develop and to validate a model of prediction of the pain in old
      subject at the time of the care, using the measure of variation of the skin conductance.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Correlation between Number of pics of skin conductance per second measured by Pain Monitor™ device with Numerical visual scale score for pain
time frame: 14 days
measure: Hospital Anxiety and Depression (HAD) score
time frame: 14 days
measure: Percentage of efficient poses of Pain Monitor
time frame: 14 days
measure: Percentage of patient refusal to use of the Pain monitor
time frame: 14 days
arm group label: Aged, 65 and over
arm group type: Experimental
intervention type: Device
intervention name: Pain Monitor™
description: Pain measured by Pain Monitor™
arm group label: Aged, 65 and over
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Marc Fischler, MD, PhD
role: Study Director
affiliation: Hopital Foch
facility: 
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No