<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/NCT01707212</url>
  </required_header>
  <id_info>
    <org_study_id>12-0134-E</org_study_id>
    <nct_id>NCT01707212</nct_id>
  </id_info>
  <brief_title>Prenatal Education About Infant Immunization Pain Management</brief_title>
  <official_title>A Prenatal Education Module for Parents to Improve the Use of Pain-management Strategies for Immunization in Two-month Old Infants: a Randomized Controlled Trial of Knowledge Translation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mount Sinai Hospital, New York</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>
      There are numerous pain management strategies available for the management of infant&#xD;
      immunization pain. The majority of infants, however do not benefit from these interventions,&#xD;
      which causes them to suffer pain unnecessarily. This study will assess the impact of&#xD;
      educating parents about pain management strategies on their knowledge and behaviour regarding&#xD;
      pain management during routine 2-month infant immunization injections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is ample literature outlining effective pain management strategies for immunization&#xD;
      including psychological, physical and pharmacological interventions; however their use in&#xD;
      clinical practice has been limited. Teaching parents about these strategies in an enriching&#xD;
      setting such as prenatal education classes has the potential to increase utilization of these&#xD;
      strategies, and empower parents to take on a more active role in the management of their&#xD;
      infant's pain during routine immunization. Educating parents about pain-management for infant&#xD;
      immunization has not been previously investigated in this setting. The aim of this&#xD;
      cluster-randomized controlled trial is to evaluate the effectiveness of an immunization&#xD;
      pain-management education module added to the prenatal education program at Mount Sinai&#xD;
      Hospital on parental knowledge and behaviour regarding pain management during routine 2-month&#xD;
      infant immunization injections.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 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>Utilization of pain management strategies during infant immunization</measure>
    <time_frame>within 2 months of immunization</time_frame>
    <description>Parents will self-report utilization of specific pain management strategies during routine 2-month infant immunization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Attempted use of pain management strategies during infant immunization</measure>
    <time_frame>within 2 months of immunization</time_frame>
    <description>Parents will self-reported attempted utilization of specific pain management strategies at 2-month infant immunization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge</measure>
    <time_frame>within 2 months of immunization</time_frame>
    <description>Parents will answer questions regarding their knowledge about the effectiveness of various pain management strategies for infant immunization injections</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Infant pain during immunization</measure>
    <time_frame>within 2 months of immunization</time_frame>
    <description>Parents will self-report infant pain during 2-month immunization using an 11-point Numerical Rating Scale (NRS)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">197</enrollment>
  <condition>Immunization</condition>
  <arm_group>
    <arm_group_label>Pain management education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Education about pain management during infant 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 - general information about immunization only</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pain management education</intervention_name>
    <description>Education about pain management during infant 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 - no education about pain management during infant immunization</description>
    <arm_group_label>No pain management education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  mothers attending weekend prenatal classes&#xD;
&#xD;
          -  delivery of a healthy newborn &gt; 35 weeks gestational age&#xD;
&#xD;
          -  available for followup for infant's 2-month immunization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  mothers who do not plan to immunize their infants&#xD;
&#xD;
          -  infant with major birth defect or hospitalized at time of immunization&#xD;
&#xD;
          -  mothers who need to attend the prenatal class at a separate time when education not&#xD;
             offered&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>October 26, 2013</last_update_submitted>
  <last_update_submitted_qc>October 26, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 2013</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/NCT01707212
org study id: 12-0134-E
nct id: NCT01707212
lead sponsor: 
collaborator: 
has dmc: No
There are numerous pain management strategies available for the management of infant
      immunization pain. The majority of infants, however do not benefit from these interventions,
      which causes them to suffer pain unnecessarily. This study will assess the impact of
      educating parents about pain management strategies on their knowledge and behaviour regarding
      pain management during routine 2-month infant immunization injections.
There is ample literature outlining effective pain management strategies for immunization
      including psychological, physical and pharmacological interventions; however their use in
      clinical practice has been limited. Teaching parents about these strategies in an enriching
      setting such as prenatal education classes has the potential to increase utilization of these
      strategies, and empower parents to take on a more active role in the management of their
      infant's pain during routine immunization. Educating parents about pain-management for infant
      immunization has not been previously investigated in this setting. The aim of this
      cluster-randomized controlled trial is to evaluate the effectiveness of an immunization
      pain-management education module added to the prenatal education program at Mount Sinai
      Hospital on parental knowledge and behaviour regarding pain management during routine 2-month
      infant immunization injections.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Utilization of pain management strategies during infant immunization
time frame: within 2 months of immunization
description: Parents will self-report utilization of specific pain management strategies during routine 2-month infant immunization
measure: Attempted use of pain management strategies during infant immunization
time frame: within 2 months of immunization
description: Parents will self-reported attempted utilization of specific pain management strategies at 2-month infant immunization
measure: Knowledge
time frame: within 2 months of immunization
description: Parents will answer questions regarding their knowledge about the effectiveness of various pain management strategies for infant immunization injections
measure: Infant pain during immunization
time frame: within 2 months of immunization
description: Parents will self-report infant pain during 2-month immunization using an 11-point Numerical Rating Scale (NRS)
arm group label: Pain management education
arm group type: Experimental
description: Education about pain management during infant immunization
arm group label: No pain management education
arm group type: Other
description: Control - general information about immunization only
intervention type: Behavioral
intervention name: Pain management education
description: Education about pain management during infant immunization
arm group label: Pain management education
intervention type: Behavioral
intervention name: No pain management education
description: Control - no education about pain management during infant immunization
arm group label: No pain management education
criteria: 
gender: Female
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Toronto
investigator full name: Anna Taddio
investigator title: Associate Professor