<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/NCT01713322</url>
  </required_header>
  <id_info>
    <org_study_id>12-195C</org_study_id>
    <nct_id>NCT01713322</nct_id>
  </id_info>
  <brief_title>Testing Educational Materials in a Paediatric Setting</brief_title>
  <official_title>Testing Educational Materials About Immunizations in a Paediatric Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Immunization procedures are a common source of iatrogenic pain for infants. A recently&#xD;
      developed clinical practice guideline, led by Taddio et al., created evidence-based&#xD;
      strategies for management of immunization pain. User-friendly educational tools outlining&#xD;
      these strategies were made. The goal of cluster randomized controlled trial is to assess&#xD;
      whether these educational materials increase utilization of pain-relieving strategies by&#xD;
      parents during infant immunizations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Immunization procedures are a common source of iatrogenic pain for infants. A recently&#xD;
      developed clinical practice guideline led by Taddio et al. provides evidence-based&#xD;
      recommendations for the management of immunization pain in children. User-friendly&#xD;
      educational tools based on the guideline have also been developed, including a factsheet and&#xD;
      educational video. The primary objective of this study is to assess whether these materials&#xD;
      can increase utilization of pain -relieving strategies by parents during immunizations.&#xD;
      Parents will be recruited during their infant's 2-month or 4-month scheduled visit to receive&#xD;
      either the educational material related to immunization pain management (intervention group)&#xD;
      or general information about immunization (control group). The study team will then follow&#xD;
      these infants at their current and upcoming immunizations visit and document the pain&#xD;
      management strategies utilized, infant pain responses, and parental satisfaction with pain&#xD;
      management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <primary_completion_date type="Anticipated">September 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of pain management strategies utilized</measure>
    <time_frame>During immunization</time_frame>
    <description>The number of pain management strategies utilized during immunization injections measured post-intervention from videotapes by a blinded assessor.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain during infant immunizations</measure>
    <time_frame>During immunization</time_frame>
    <description>Pain during infant immunizations, as measured by a validated measure of pain in infants, the Modified Behavioural Pain Scale (MBPS), by trained and blinded research assistants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent behaviour during infant immunizations</measure>
    <time_frame>During immunization</time_frame>
    <description>Parent behaviour during infant immunizations, as measured by Measure of Adult and Infant Soothing and Distress (MAISD) tool by trained and blinded research assistants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain during infant immunizations as reported by parents</measure>
    <time_frame>During immunization</time_frame>
    <description>Pain during immunization appointments, as reported by parents using the Numerical Rating Scale (NRS), in real-time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent-reported satisfaction with immunization experience</measure>
    <time_frame>During immunization</time_frame>
    <description>Parent-reported satisfaction with their immunization experience in their infant during immunization appointments on a 5-point Likert scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of infant crying during immunizations</measure>
    <time_frame>During immunization</time_frame>
    <description>Duration of infant crying during infant immunizations, measured in seconds, will be assessed from videotapes by a trained and blinded assessor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain during infant immunizations</measure>
    <time_frame>During immunizations</time_frame>
    <description>Pain during infant immunizations will be assessed by researchers, in real time, using the Numerical Rating Scale (NRS)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Immunization</condition>
  <arm_group>
    <arm_group_label>Pain management education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parents are provided with educational material on how to manage child pain during immunization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No pain management education</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Control - parents receive general information about childhood immunization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pain management education</intervention_name>
    <description>Parents are provided with educational material on how to manage child pain during immunization.</description>
    <arm_group_label>Pain management education</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>No pain management education</intervention_name>
    <description>Control - parents receive general information about childhood immunization.</description>
    <arm_group_label>No pain management education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents of 2 or 4-month old healthy infants during routine immunization appointments&#xD;
&#xD;
          -  Parent accompanies infant at immunization appointments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parents of infants &lt;30 weeks gestational age (GA)&#xD;
&#xD;
          -  Parents delaying infant immunization for &gt;2 months&#xD;
&#xD;
          -  Parents who are unable to read and understand English&#xD;
&#xD;
          -  Infants with congenital anomalies, neurological conditions, and maternal psychiatric&#xD;
             conditions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna Taddio, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anna Taddio, PhD</last_name>
    <phone>416-978-8822</phone>
    <email>anna.taddio@utoronto.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael Sgro, MD</last_name>
    <phone>416-864-6060</phone>
    <phone_ext>6560</phone_ext>
    <email>sgrom@smh.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St. Michael's Health Center, Pediatric Clinic.</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Micheal Sgro, MD</last_name>
      <phone>416-864-6060</phone>
      <phone_ext>6560</phone_ext>
      <email>SgroM@smh.ca</email>
    </contact>
    <contact_backup>
      <last_name>Anna Taddio, PhD</last_name>
      <phone>416-978-8822</phone>
      <email>anna.taddio@utoronto.ca</email>
    </contact_backup>
    <investigator>
      <last_name>Micheal Sgro, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>October 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>December 21, 2012</last_update_submitted>
  <last_update_submitted_qc>December 21, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 24, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Toronto</investigator_affiliation>
    <investigator_full_name>Anna Taddio</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>parent education</keyword>
  <keyword>pain management</keyword>
  <keyword>immunization</keyword>
  <keyword>infant</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/NCT01713322
org study id: 12-195C
nct id: NCT01713322
lead sponsor: 
collaborator: 
has dmc: No
Immunization procedures are a common source of iatrogenic pain for infants. A recently
      developed clinical practice guideline, led by Taddio et al., created evidence-based
      strategies for management of immunization pain. User-friendly educational tools outlining
      these strategies were made. The goal of cluster randomized controlled trial is to assess
      whether these educational materials increase utilization of pain-relieving strategies by
      parents during infant immunizations.
Immunization procedures are a common source of iatrogenic pain for infants. A recently
      developed clinical practice guideline led by Taddio et al. provides evidence-based
      recommendations for the management of immunization pain in children. User-friendly
      educational tools based on the guideline have also been developed, including a factsheet and
      educational video. The primary objective of this study is to assess whether these materials
      can increase utilization of pain -relieving strategies by parents during immunizations.
      Parents will be recruited during their infant's 2-month or 4-month scheduled visit to receive
      either the educational material related to immunization pain management (intervention group)
      or general information about immunization (control group). The study team will then follow
      these infants at their current and upcoming immunizations visit and document the pain
      management strategies utilized, infant pain responses, and parental satisfaction with pain
      management.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Number of pain management strategies utilized
time frame: During immunization
description: The number of pain management strategies utilized during immunization injections measured post-intervention from videotapes by a blinded assessor.
measure: Pain during infant immunizations
time frame: During immunization
description: Pain during infant immunizations, as measured by a validated measure of pain in infants, the Modified Behavioural Pain Scale (MBPS), by trained and blinded research assistants.
measure: Parent behaviour during infant immunizations
time frame: During immunization
description: Parent behaviour during infant immunizations, as measured by Measure of Adult and Infant Soothing and Distress (MAISD) tool by trained and blinded research assistants.
measure: Pain during infant immunizations as reported by parents
time frame: During immunization
description: Pain during immunization appointments, as reported by parents using the Numerical Rating Scale (NRS), in real-time.
measure: Parent-reported satisfaction with immunization experience
time frame: During immunization
description: Parent-reported satisfaction with their immunization experience in their infant during immunization appointments on a 5-point Likert scale.
measure: Duration of infant crying during immunizations
time frame: During immunization
description: Duration of infant crying during infant immunizations, measured in seconds, will be assessed from videotapes by a trained and blinded assessor.
measure: Pain during infant immunizations
time frame: During immunizations
description: Pain during infant immunizations will be assessed by researchers, in real time, using the Numerical Rating Scale (NRS)
arm group label: Pain management education
arm group type: Experimental
description: Parents are provided with educational material on how to manage child pain during immunization.
arm group label: No pain management education
arm group type: Other
description: Control - parents receive general information about childhood immunization.
intervention type: Behavioral
intervention name: Pain management education
description: Parents are provided with educational material on how to manage child pain during immunization.
arm group label: Pain management education
intervention type: Behavioral
intervention name: No pain management education
description: Control - parents receive general information about childhood immunization.
arm group label: No pain management education
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Anna Taddio, PhD
role: Principal Investigator
affiliation: University of Toronto
last name: Anna Taddio, PhD
phone: 416-978-8822
email: anna.taddio@utoronto.ca
last name: Michael Sgro, MD
phone: 416-864-6060
phone ext: 6560
email: sgrom@smh.ca
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Toronto
investigator full name: Anna Taddio
investigator title: Associate Professor