<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/NCT02969902</url>
  </required_header>
  <id_info>
    <org_study_id>RC 19/13</org_study_id>
    <nct_id>NCT02969902</nct_id>
  </id_info>
  <brief_title>Buzzy Distraction During Venipuncture</brief_title>
  <official_title>Randomized Controlled Trial to Compare Buzzy and Hand-held Computer Distraction for Pain Control in Children Underwent Venipuncture.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Burlo Garofolo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Burlo Garofolo</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>
      Venipuncture is one of the most common iatrogenic painful and stressful procedures performed&#xD;
      on children. Interventions aimed at reducing the distress related to this experience are&#xD;
      widely and strongly recommended. Pain and anxiety management is even more essential because&#xD;
      it may modify children's memory for procedural pain and the subsequent acceptance of later&#xD;
      health care painful interventions. Distraction is the most studied psychological technique to&#xD;
      relieve venipuncture related pain and distress, with a strong evidence supporting its&#xD;
      efficacy in children and adolescents.&#xD;
&#xD;
      In recent years several studies showed the effectiveness of a specific tool named Buzzy® (MMJ&#xD;
      Labs, Atlanta GA, USA), in relieving pain and distress in children. Buzzy combines&#xD;
      distraction and physical analgesia (vibration and cold) and it was positively tested during&#xD;
      venipuncture, intravenous cannulation and painful injections in children. Even though its&#xD;
      efficacy it's well established, most of the published trials did not compare Buzzy with other&#xD;
      interventions, so that little data are available about its usefulness compared with other&#xD;
      distractions techniques.&#xD;
&#xD;
      Hand-held computers are reusable tools, which offer a technological-based active distraction.&#xD;
      There is evidence supporting their used during painful procedures such as venipuncture and a&#xD;
      recent published study showed that hand-held computer distraction was as effective as&#xD;
      nurse-led passive distraction techniques in children.&#xD;
&#xD;
      The aim of this study is to compare the effectiveness of Buzzy versus hand-held computer in&#xD;
      pain relief during venipuncture.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported pain</measure>
    <time_frame>Within 5 minutes after the procedure</time_frame>
    <description>Children from 4 to 7 years of age record their pain using the Faces Pain Scale-Revised (FPS-R); children from 8 to 12 years using a Numerical Rating Scale, with scores from zero to 10.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain evaluated by parents</measure>
    <time_frame>Within 5 minutes after the procedure</time_frame>
    <description>Pain evaluated using a Numerical Rating Scale, with scores from zero to 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain evaluated by nurses</measure>
    <time_frame>Within 5 minutes after the procedure</time_frame>
    <description>Pain evaluated using a Numerical Rating Scale, with scores from zero to 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success at first attempt</measure>
    <time_frame>Intraprocedural</time_frame>
    <description>Percentage of success at first attempt</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Up to 15 minutes after the procedure</time_frame>
    <description>The number and the type of adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Pain Relief</condition>
  <arm_group>
    <arm_group_label>Buzzy® device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Buzzy® device is applied just above the selected site of the venipuncture; an ice pack is attached under the device; the device is turned on and after 15 second the venipuncture is made.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hand-held computer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Using an hand-held computer, children start to play with an age-appropriate videogame three minutes before the procedure. They continue to play during the venipuncture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Buzzy® device</intervention_name>
    <arm_group_label>Buzzy® device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Hand-held computer</intervention_name>
    <arm_group_label>Hand-held computer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children from 4 to 12 years of age needing venipuncture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  the presence of damage, denuded or broken skin in the site of Buzzy application;&#xD;
&#xD;
          -  use of topical, enteral or parenteral analgesics within eight hours before enrolment;&#xD;
&#xD;
          -  the presence of cognitive impairment or the inability to report pain verbally;&#xD;
&#xD;
          -  the presence of chronic disease, included epilepsy, or of diseases associated with&#xD;
             cold hypersensitivity (i.e., sickle cell anaemia, Raynaud's disease).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Egidio Barbi, MD</last_name>
    <role>Study Chair</role>
    <affiliation>IRCCS Burlo Garofolo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Franca Crevatin, RN</last_name>
    <role>Study Director</role>
    <affiliation>IRCCS Burlo Garofolo</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Burlo Garofolo</investigator_affiliation>
    <investigator_full_name>Luca Ronfani</investigator_full_name>
    <investigator_title>Head of Clinical Epidemiology and Public Health Research Unit</investigator_title>
  </responsible_party>
  <keyword>Procedural pain</keyword>
  <keyword>Phlebotomy</keyword>
  <keyword>Distraction</keyword>
  <keyword>Hand-held computer</keyword>
  <keyword>Children</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/NCT02969902
org study id: RC 19/13
nct id: NCT02969902
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Venipuncture is one of the most common iatrogenic painful and stressful procedures performed
      on children. Interventions aimed at reducing the distress related to this experience are
      widely and strongly recommended. Pain and anxiety management is even more essential because
      it may modify children's memory for procedural pain and the subsequent acceptance of later
      health care painful interventions. Distraction is the most studied psychological technique to
      relieve venipuncture related pain and distress, with a strong evidence supporting its
      efficacy in children and adolescents.

      In recent years several studies showed the effectiveness of a specific tool named Buzzy® (MMJ
      Labs, Atlanta GA, USA), in relieving pain and distress in children. Buzzy combines
      distraction and physical analgesia (vibration and cold) and it was positively tested during
      venipuncture, intravenous cannulation and painful injections in children. Even though its
      efficacy it's well established, most of the published trials did not compare Buzzy with other
      interventions, so that little data are available about its usefulness compared with other
      distractions techniques.

      Hand-held computers are reusable tools, which offer a technological-based active distraction.
      There is evidence supporting their used during painful procedures such as venipuncture and a
      recent published study showed that hand-held computer distraction was as effective as
      nurse-led passive distraction techniques in children.

      The aim of this study is to compare the effectiveness of Buzzy versus hand-held computer in
      pain relief during venipuncture.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Self-reported pain
time frame: Within 5 minutes after the procedure
description: Children from 4 to 7 years of age record their pain using the Faces Pain Scale-Revised (FPS-R); children from 8 to 12 years using a Numerical Rating Scale, with scores from zero to 10.
measure: Pain evaluated by parents
time frame: Within 5 minutes after the procedure
description: Pain evaluated using a Numerical Rating Scale, with scores from zero to 10
measure: Pain evaluated by nurses
time frame: Within 5 minutes after the procedure
description: Pain evaluated using a Numerical Rating Scale, with scores from zero to 10
measure: Success at first attempt
time frame: Intraprocedural
description: Percentage of success at first attempt
measure: Adverse events
time frame: Up to 15 minutes after the procedure
description: The number and the type of adverse events
arm group label: Buzzy® device
arm group type: Experimental
description: The Buzzy® device is applied just above the selected site of the venipuncture; an ice pack is attached under the device; the device is turned on and after 15 second the venipuncture is made.
arm group label: Hand-held computer
arm group type: Active Comparator
description: Using an hand-held computer, children start to play with an age-appropriate videogame three minutes before the procedure. They continue to play during the venipuncture.
intervention type: Device
intervention name: Buzzy® device
arm group label: Buzzy® device
intervention type: Device
intervention name: Hand-held computer
arm group label: Hand-held computer
criteria: 
gender: All
minimum age: 4 Years
maximum age: 12 Years
healthy volunteers: No
last name: Egidio Barbi, MD
role: Study Chair
affiliation: IRCCS Burlo Garofolo
last name: Franca Crevatin, RN
role: Study Director
affiliation: IRCCS Burlo Garofolo
responsible party type: Principal Investigator
investigator affiliation: IRCCS Burlo Garofolo
investigator full name: Luca Ronfani
investigator title: Head of Clinical Epidemiology and Public Health Research Unit