<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/NCT01731834</url>
  </required_header>
  <id_info>
    <org_study_id>11212PSC014</org_study_id>
    <secondary_id>FUUberlandia</secondary_id>
    <nct_id>NCT01731834</nct_id>
  </id_info>
  <brief_title>Pain and Stress Assessment in Children</brief_title>
  <official_title>Pain and Stress Assessment in Children Undergoing Respiratory Physical Therapy Techniques</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Uberlandia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Uberlandia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There may be pain and / or stress with vibrocompression. There may be pain and / or stress&#xD;
      with the aspiration of secretions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomization to 10 children and 10 vibrocompression for aspiration of secretion.&#xD;
&#xD;
      Fill in the evaluation form. Monitoring Heart Rate and Peripheral O2 Saturation (rest, during&#xD;
      and after the technique performed).&#xD;
&#xD;
      Photographic Record (rest, during and after the technique performed). Saliva Collection&#xD;
      (rest, 5, 20 and 40 minutes after running technics). Data analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess whether there is pain in children when performed randomized technique</measure>
    <time_frame>two years</time_frame>
    <description>Rate NIPS - Infant Pain Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess whether there is stress in children during the technical run</measure>
    <time_frame>two years</time_frame>
    <description>Biochemical analysis of cortisol and salivary amylase</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Correlate the pain and the stress generated.</measure>
    <time_frame>two yars</time_frame>
    <description>Also assess heart rate, respiratory rate, and oxygen saturation.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Acute Respiratory Infections</condition>
  <arm_group>
    <arm_group_label>Aspiration of secretion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 children are evaluated at rest, during and after aspiration technique secretion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vibrocompression</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 children will be assessed at rest, during and after the maneuver vibrocompression</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vibrocompression and aspiration of secretions</intervention_name>
    <description>The 20 children, study participants will be randomly assigned to different groups, where 10 children will be evaluated during vibrocompression maneuver, and another 10 will be assessed on the aspiration procedure. Randomization will be performed using an opaque envelope for specifying which group selection technique is evaluated.</description>
    <arm_group_label>Aspiration of secretion</arm_group_label>
    <arm_group_label>Vibrocompression</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indication of Respiratory Therapy&#xD;
&#xD;
        Fasting for one hour before the moment of collection&#xD;
&#xD;
        Term of Free and Informed Consent Form (ICF) signed by parents or legal guardians&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children in postoperative period acute&#xD;
&#xD;
        Presence of thoracic drain or mediastinal&#xD;
&#xD;
        Children using drugs to sedative or analgesic purpose of deep sedation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>1 Year</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Biasi, Third</last_name>
    <role>Principal Investigator</role>
    <affiliation>FUUberlândia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>FUUberlândia</name>
      <address>
        <city>Uberlândia</city>
        <state>Minas Gerais</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>November 18, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>November 27, 2013</last_update_submitted>
  <last_update_submitted_qc>November 27, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Uberlandia</investigator_affiliation>
    <investigator_full_name>Maria Teresa de Mendonça Biasi</investigator_full_name>
    <investigator_title>Assessment of pain and stress in children undergoing respiratory physiotherapy</investigator_title>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>Stress</keyword>
  <keyword>Physiotherapy</keyword>
  <keyword>Children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Tract Infections</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>August 4, 2014</submitted>
    <returned>August 20, 2014</returned>
  </pending_results>
  <!-- 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/NCT01731834
org study id: 11212PSC014
secondary id: FUUberlandia
nct id: NCT01731834
lead sponsor: 
has dmc: No
There may be pain and / or stress with vibrocompression. There may be pain and / or stress
      with the aspiration of secretions.
Randomization to 10 children and 10 vibrocompression for aspiration of secretion.

      Fill in the evaluation form. Monitoring Heart Rate and Peripheral O2 Saturation (rest, during
      and after the technique performed).

      Photographic Record (rest, during and after the technique performed). Saliva Collection
      (rest, 5, 20 and 40 minutes after running technics). Data analysis.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Assess whether there is pain in children when performed randomized technique
time frame: two years
description: Rate NIPS - Infant Pain Scale
measure: Assess whether there is stress in children during the technical run
time frame: two years
description: Biochemical analysis of cortisol and salivary amylase
measure: Correlate the pain and the stress generated.
time frame: two yars
description: Also assess heart rate, respiratory rate, and oxygen saturation.
arm group label: Aspiration of secretion
arm group type: Active Comparator
description: 10 children are evaluated at rest, during and after aspiration technique secretion
arm group label: Vibrocompression
arm group type: Experimental
description: 10 children will be assessed at rest, during and after the maneuver vibrocompression
intervention type: Other
intervention name: Vibrocompression and aspiration of secretions
description: The 20 children, study participants will be randomly assigned to different groups, where 10 children will be evaluated during vibrocompression maneuver, and another 10 will be assessed on the aspiration procedure. Randomization will be performed using an opaque envelope for specifying which group selection technique is evaluated.
arm group label: Aspiration of secretion
arm group label: Vibrocompression
criteria: 
gender: All
minimum age: 1 Day
maximum age: 1 Year
healthy volunteers: No
last name: Maria Biasi, Third
role: Principal Investigator
affiliation: FUUberlândia
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Uberlandia
investigator full name: Maria Teresa de Mendonça Biasi
investigator title: Assessment of pain and stress in children undergoing respiratory physiotherapy
mesh term: Respiratory Tract Infections
submitted: August 4, 2014
returned: August 20, 2014