<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/NCT02252003</url>
  </required_header>
  <id_info>
    <org_study_id>2013.811</org_study_id>
    <secondary_id>2013-A00849-36</secondary_id>
    <nct_id>NCT02252003</nct_id>
  </id_info>
  <brief_title>Development and Validation of a New Pain Scale for Children</brief_title>
  <acronym>NOUNOURS</acronym>
  <official_title>Development of a New Pain Rating Scale for Children and Validation Against Criteria by Comparison With Faces Pain Scale - Revised (FPS-R) and Visual Analogue Scale (VAS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In clinical practice with young children, gold standard rating scales used to evaluate the&#xD;
      pain are VAS (Visual Analogue Scale) and FPS-R (Faces Pain Scale - Revised), which are&#xD;
      self-assessment tools. These scales present however certain limitations: the VAS is not&#xD;
      applicable if the child does not know how to estimate the distances, as young children, or&#xD;
      children with mental retardation. As for FPS-R, it can be frightening for children by the&#xD;
      aspect of faces looking like impersonal masks.&#xD;
&#xD;
      For children under 4 years, only hetero-evaluation based on typical behavioral scales as Face&#xD;
      Legs Activity Cry Consolability (FLACC) can be used, according to the current&#xD;
      recommendations.&#xD;
&#xD;
      We thus wanted to create a new faces scale with teddy bear faces, which are cross-cultural&#xD;
      and timeless. Our objective is to validate the new teddy scale in its paper shape on a wide&#xD;
      sample of children. We made the hypothesis that the teddy scale would enable to evaluate the&#xD;
      pain in the same way that the FPS-R, being better accepted and preferred by children.&#xD;
&#xD;
      The first phase of this study will be to develop the teddy scale with a sample of 30 healthy&#xD;
      children from 4 to 11 year-old, having already experienced pain. This stage allows the&#xD;
      validation of the images chosen for the scale, to make sure of their relevance and their&#xD;
      optimal recognition by the children.&#xD;
&#xD;
      The scale will then be validated with a sample of 218 hospitalized children from 2 to 11&#xD;
      years old, to whom pain is usually evaluated in a systematic way. Children from 4 to 11 years&#xD;
      old will have simultaneously the teddy scale, the VAS and the FPS-R. They will be asked to&#xD;
      determine which scale they preferred. Children from 2 to 4 years old will have the teddy&#xD;
      scale; the FLACC will be filled in by parents.&#xD;
&#xD;
      Tested hypothesis: The discriminating characteristic of the teddy scale is superior to that&#xD;
      of the FPS-R scale The validation of the teddy scale will enable to objectify children's&#xD;
      pain, to facilitate the decision-making in the choice of the analgesic to prescribe, and to&#xD;
      check the efficiency of these decisions. This teddy scale could be used in current practice&#xD;
      as a replacement of the FPS-R.&#xD;
&#xD;
      Following this study, we planned to set up a second project in which the teddy scale will be&#xD;
      adapted to electronic form (touchpads), to test its adaptability with the children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 21, 2015</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain assessment (4-11 years old)</measure>
    <time_frame>Baseline</time_frame>
    <description>Children aged 4-11 will be asked to score the pain they feel at that time, using the 3 scales presented in a randomly assigned order. The measure of the correlation between the scores of the 3 pain scales: VAS score (continuing : 0.0 to 10.0), FPS-R score (0,2,4,6,8,10), and teddy scale score (0,2,4,6,8,10) will be evaluated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain assessment (4-11 years old) depending on age.</measure>
    <time_frame>Baseline</time_frame>
    <description>Children aged 4-11 will be asked to score the pain they feel at that time, using the 3 scales presented in a randomly assigned order. The measure of discriminating characteristics of each scale (teddy scale, FPS-R and VAS), according to the age (continuing age, or in range: 4-6, 6-8 and 8-11) will be performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scale preference (4-11 years old)</measure>
    <time_frame>Baseline</time_frame>
    <description>The 174 patients (aged 4-11 years old) will be asked to choose the scale they preferred between teddy scale, VAS and FPS-R. The number of times where the teddy scale is preferred will be counted (result expressed in percentage) and compared to the 2 other scales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensibility of change of teddy and FPS-R scales</measure>
    <time_frame>Baseline</time_frame>
    <description>The sensibility of change (before/after treatment intake) will be measured by the size-effect (mean of the differences divided by the standard deviation before treatment) and by standardized mean responses (mean of the differences divided by the differences standard deviations).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain assessment (2-3 years-old)</measure>
    <time_frame>Baseline</time_frame>
    <description>Children aged 2-3 years old will be asked to score the pain they feel at that time, using the teddy scale while parents will fill up the FLACC scale. The measure of the correlation between scores of the 2 pain scales: teddy scale score (0,2,4,6,8,10) and FLACC score (continuing from 0 to 10), will be performed using statistical models.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Pain scales testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pain scales testing</intervention_name>
    <arm_group_label>Pain scales testing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Affiliated with the French healthcare system&#xD;
&#xD;
          -  Agreed to participate in the study, of which parents/ holders of parental authority&#xD;
             signed the informed consent form&#xD;
&#xD;
        Scale development phase:&#xD;
&#xD;
          -  Children aged from 4 to 11 years at inclusion&#xD;
&#xD;
          -  Having already experienced pain&#xD;
&#xD;
        Scale validation phase:&#xD;
&#xD;
          -  Children aged from 2 to 11 years old at inclusion&#xD;
&#xD;
          -  Hospitalized in one of the Hôpital Femme-Mère-Enfant (HFME) departments&#xD;
&#xD;
          -  At risk of presenting pain, that is to whom the pain is usually evaluated in a&#xD;
             systematic way&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children among whom the understanding and/or the language is not sufficient to allow a&#xD;
             good comprehension of study instructions&#xD;
&#xD;
          -  Children participating simultaneously in another interventional research, being able&#xD;
             to interfere with the study results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carole VUILLEROT, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de Médecine Physique et Réadaptation Pédiatrique - Hôpital Femme-Mère-Enfant</name>
      <address>
        <city>Bron</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>February 12, 2018</last_update_submitted>
  <last_update_submitted_qc>February 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Children</keyword>
  <keyword>Pain</keyword>
  <keyword>Pain scale evaluation</keyword>
  <!-- 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/NCT02252003
org study id: 2013.811
secondary id: 2013-A00849-36
nct id: NCT02252003
lead sponsor: 
has dmc: No
In clinical practice with young children, gold standard rating scales used to evaluate the
      pain are VAS (Visual Analogue Scale) and FPS-R (Faces Pain Scale - Revised), which are
      self-assessment tools. These scales present however certain limitations: the VAS is not
      applicable if the child does not know how to estimate the distances, as young children, or
      children with mental retardation. As for FPS-R, it can be frightening for children by the
      aspect of faces looking like impersonal masks.

      For children under 4 years, only hetero-evaluation based on typical behavioral scales as Face
      Legs Activity Cry Consolability (FLACC) can be used, according to the current
      recommendations.

      We thus wanted to create a new faces scale with teddy bear faces, which are cross-cultural
      and timeless. Our objective is to validate the new teddy scale in its paper shape on a wide
      sample of children. We made the hypothesis that the teddy scale would enable to evaluate the
      pain in the same way that the FPS-R, being better accepted and preferred by children.

      The first phase of this study will be to develop the teddy scale with a sample of 30 healthy
      children from 4 to 11 year-old, having already experienced pain. This stage allows the
      validation of the images chosen for the scale, to make sure of their relevance and their
      optimal recognition by the children.

      The scale will then be validated with a sample of 218 hospitalized children from 2 to 11
      years old, to whom pain is usually evaluated in a systematic way. Children from 4 to 11 years
      old will have simultaneously the teddy scale, the VAS and the FPS-R. They will be asked to
      determine which scale they preferred. Children from 2 to 4 years old will have the teddy
      scale; the FLACC will be filled in by parents.

      Tested hypothesis: The discriminating characteristic of the teddy scale is superior to that
      of the FPS-R scale The validation of the teddy scale will enable to objectify children's
      pain, to facilitate the decision-making in the choice of the analgesic to prescribe, and to
      check the efficiency of these decisions. This teddy scale could be used in current practice
      as a replacement of the FPS-R.

      Following this study, we planned to set up a second project in which the teddy scale will be
      adapted to electronic form (touchpads), to test its adaptability with the children.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Pain assessment (4-11 years old)
time frame: Baseline
description: Children aged 4-11 will be asked to score the pain they feel at that time, using the 3 scales presented in a randomly assigned order. The measure of the correlation between the scores of the 3 pain scales: VAS score (continuing : 0.0 to 10.0), FPS-R score (0,2,4,6,8,10), and teddy scale score (0,2,4,6,8,10) will be evaluated.
measure: Pain assessment (4-11 years old) depending on age.
time frame: Baseline
description: Children aged 4-11 will be asked to score the pain they feel at that time, using the 3 scales presented in a randomly assigned order. The measure of discriminating characteristics of each scale (teddy scale, FPS-R and VAS), according to the age (continuing age, or in range: 4-6, 6-8 and 8-11) will be performed.
measure: Scale preference (4-11 years old)
time frame: Baseline
description: The 174 patients (aged 4-11 years old) will be asked to choose the scale they preferred between teddy scale, VAS and FPS-R. The number of times where the teddy scale is preferred will be counted (result expressed in percentage) and compared to the 2 other scales.
measure: Sensibility of change of teddy and FPS-R scales
time frame: Baseline
description: The sensibility of change (before/after treatment intake) will be measured by the size-effect (mean of the differences divided by the standard deviation before treatment) and by standardized mean responses (mean of the differences divided by the differences standard deviations).
measure: Pain assessment (2-3 years-old)
time frame: Baseline
description: Children aged 2-3 years old will be asked to score the pain they feel at that time, using the teddy scale while parents will fill up the FLACC scale. The measure of the correlation between scores of the 2 pain scales: teddy scale score (0,2,4,6,8,10) and FLACC score (continuing from 0 to 10), will be performed using statistical models.
arm group label: Pain scales testing
arm group type: Experimental
intervention type: Other
intervention name: Pain scales testing
arm group label: Pain scales testing
criteria: 
gender: All
minimum age: 2 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carole VUILLEROT, MD
role: Principal Investigator
affiliation: Hospices Civils de Lyon
facility: 
country: France
responsible party type: Sponsor