<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/NCT03004456</url>
  </required_header>
  <id_info>
    <org_study_id>AAAQ8828</org_study_id>
    <nct_id>NCT03004456</nct_id>
  </id_info>
  <brief_title>Distraction for Reduction of Pain Associated With Venipuncture in the Pediatric Post-Transplant Population</brief_title>
  <official_title>Efficacy of Distraction on Reduction of Procedural Pain Associated With Venipuncture in the Pediatric Post-Transplant Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</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>
      Children with chronic diseases, particularly those who have received transplantation (e.g.&#xD;
      cardiac, renal, or liver) are a population who undergo frequent painful procedures, such as&#xD;
      venipuncture multiple times per week. There is currently no standard of care for pain&#xD;
      reduction during venipuncture for pediatric patients having blood drawn in phlebotomy as an&#xD;
      outpatient. The study aims to determine the efficacy of distraction in reducing procedural&#xD;
      pain and distress associated with venipuncture in pediatric post-transplant patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children with chronic illnesses experience frequent painful experiences over extended periods&#xD;
      of time, and may develop long-term physiological, psychological and behavioral sequelae&#xD;
      including increased sensitivity to pain and higher levels of anxiety before painful&#xD;
      procedures. There is strong evidence to show that distraction is effective in reducing&#xD;
      children's pain and distress during painful procedures. However, the evidence to support&#xD;
      distraction, as well as other methods of pain reduction during venipuncture (i.e. vibration,&#xD;
      topical anesthetics, sucrose), has primarily focused on children who are previously well, as&#xD;
      those with chronic disease are an understudied population with regards to pain reduction&#xD;
      during simple procedures. Children with chronic disease or pathology, particularly those who&#xD;
      have received transplantation (e.g. cardiac, renal, liver), are a population who undergo&#xD;
      frequent painful procedures, such as venipuncture multiple times per week. There is currently&#xD;
      no standard of care for pain reduction during venipuncture for pediatric patients having&#xD;
      blood drawn in phlebotomy or in the transplant clinics as an outpatient.&#xD;
&#xD;
      The investigators will conduct a randomized control trial comparing two groups: Distraction&#xD;
      versus standard of care (i.e. no distraction). The intervention (distraction) will be&#xD;
      administered using an iPad and allowing the child to self-select a developmentally&#xD;
      appropriate distraction (e.g. game, movie, music). Participants will be videotaped for&#xD;
      approximately 1 minute, starting from the time of the venipuncture. This video will be viewed&#xD;
      at a later date by two trained study investigators to assess the patient's pain and distress&#xD;
      associated with venipuncture, as measured by the OSBD-r, CHEOPS, and FLACC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 10, 2017</start_date>
  <completion_date type="Actual">June 13, 2018</completion_date>
  <primary_completion_date type="Actual">June 13, 2018</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>Faces Pain Scale - Revised (FPS-R)</measure>
    <time_frame>1 minute</time_frame>
    <description>Faces Pain Scale is a self-report measure of pain intensity developed for children. The scale is intended to measure how children feel inside. &quot;0&quot; equals &quot;No pain&quot; and &quot;10&quot; equals &quot;Very much pain.&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Observational Scale of Behavioral Distress - revised (OSBD-r)</measure>
    <time_frame>1 minute</time_frame>
    <description>OSBD-r is an observational measure of procedural distress. The behaviors assessed in the OSBD-r include cry, scream, restraint, verbal resistance, information seeking, emotional support, verbal pain and flail. Distress behaviors are weighted on a 1-4 point scale to reflect the intensity of distress. The higher scores indicated a greater level of distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Faces-Leg- Activity-Cry-Consolability (FLACC)</measure>
    <time_frame>1 minute</time_frame>
    <description>FLACC is an observational measure of procedural pain. Categories for scoring include Face, Legs, Activity, Cry, and Consolability. Total points assigned for each category may be from zero to ten. The numeric rating scale may be categorized into no pain, mild pain, moderate pain, and severe pain based on the 0 (representing no pain) -10 (severe pain) self-report scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children's Hospital of Eastern Ontario Pain Scale (CHEOPS)</measure>
    <time_frame>1 minute</time_frame>
    <description>CHEOPS is an observational scale for evaluating postoperative pain in young children. It includes six categories of pain behavior, each with 3-4 levels and scores range from 4 points (no pain) to 13 points (the worst pain).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Time to successful venipuncture</measure>
    <time_frame>Less than 5 minutes</time_frame>
    <description>Defined as the time from placing of tourniquet to completion of collection of the first tube.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of attempts necessary for successful blood draw.</measure>
    <time_frame>Less than 5 minutes</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction evaluation</measure>
    <time_frame>Less than 5 minutes</time_frame>
    <description>Satisfaction of phlebotomists and parents will be assessed by a Likert-type survey administered immediately after the blood draw</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Pain, Procedural</condition>
  <condition>Distress, Procedural</condition>
  <condition>Venipuncture</condition>
  <arm_group>
    <arm_group_label>Distraction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to the &quot;Distraction&quot; group will be permitted to choose an age appropriate application (e.g. movie, game) which will be held for them during the blood draw.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients randomized to the &quot;Standard of Care&quot; group will not be provided with an iPad.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Distraction</intervention_name>
    <description>Distraction will be provided by allowing the patient to will choose an age appropriate application (e.g. movie, game) which will be held for them during the blood draw.</description>
    <arm_group_label>Distraction</arm_group_label>
    <other_name>iPad</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of solid organ transplantation&#xD;
&#xD;
          -  Undergoing venipuncture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Blood being drawn from a central line&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel S Tsze, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>April 17, 2019</last_update_submitted>
  <last_update_submitted_qc>April 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Daniel S Tsze, MD, MPH</investigator_full_name>
    <investigator_title>Assistant Professor of Pediatrics at the Columbia University Medical Center</investigator_title>
  </responsible_party>
  <keyword>Phlebotomy</keyword>
  <keyword>Pain</keyword>
  <keyword>Distress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Procedural</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03004456
org study id: AAAQ8828
nct id: NCT03004456
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Children with chronic diseases, particularly those who have received transplantation (e.g.
      cardiac, renal, or liver) are a population who undergo frequent painful procedures, such as
      venipuncture multiple times per week. There is currently no standard of care for pain
      reduction during venipuncture for pediatric patients having blood drawn in phlebotomy as an
      outpatient. The study aims to determine the efficacy of distraction in reducing procedural
      pain and distress associated with venipuncture in pediatric post-transplant patients.
Children with chronic illnesses experience frequent painful experiences over extended periods
      of time, and may develop long-term physiological, psychological and behavioral sequelae
      including increased sensitivity to pain and higher levels of anxiety before painful
      procedures. There is strong evidence to show that distraction is effective in reducing
      children's pain and distress during painful procedures. However, the evidence to support
      distraction, as well as other methods of pain reduction during venipuncture (i.e. vibration,
      topical anesthetics, sucrose), has primarily focused on children who are previously well, as
      those with chronic disease are an understudied population with regards to pain reduction
      during simple procedures. Children with chronic disease or pathology, particularly those who
      have received transplantation (e.g. cardiac, renal, liver), are a population who undergo
      frequent painful procedures, such as venipuncture multiple times per week. There is currently
      no standard of care for pain reduction during venipuncture for pediatric patients having
      blood drawn in phlebotomy or in the transplant clinics as an outpatient.

      The investigators will conduct a randomized control trial comparing two groups: Distraction
      versus standard of care (i.e. no distraction). The intervention (distraction) will be
      administered using an iPad and allowing the child to self-select a developmentally
      appropriate distraction (e.g. game, movie, music). Participants will be videotaped for
      approximately 1 minute, starting from the time of the venipuncture. This video will be viewed
      at a later date by two trained study investigators to assess the patient's pain and distress
      associated with venipuncture, as measured by the OSBD-r, CHEOPS, and FLACC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Faces Pain Scale - Revised (FPS-R)
time frame: 1 minute
description: Faces Pain Scale is a self-report measure of pain intensity developed for children. The scale is intended to measure how children feel inside. "0" equals "No pain" and "10" equals "Very much pain."
measure: Observational Scale of Behavioral Distress - revised (OSBD-r)
time frame: 1 minute
description: OSBD-r is an observational measure of procedural distress. The behaviors assessed in the OSBD-r include cry, scream, restraint, verbal resistance, information seeking, emotional support, verbal pain and flail. Distress behaviors are weighted on a 1-4 point scale to reflect the intensity of distress. The higher scores indicated a greater level of distress.
measure: Faces-Leg- Activity-Cry-Consolability (FLACC)
time frame: 1 minute
description: FLACC is an observational measure of procedural pain. Categories for scoring include Face, Legs, Activity, Cry, and Consolability. Total points assigned for each category may be from zero to ten. The numeric rating scale may be categorized into no pain, mild pain, moderate pain, and severe pain based on the 0 (representing no pain) -10 (severe pain) self-report scale.
measure: Children's Hospital of Eastern Ontario Pain Scale (CHEOPS)
time frame: 1 minute
description: CHEOPS is an observational scale for evaluating postoperative pain in young children. It includes six categories of pain behavior, each with 3-4 levels and scores range from 4 points (no pain) to 13 points (the worst pain).
measure: Time to successful venipuncture
time frame: Less than 5 minutes
description: Defined as the time from placing of tourniquet to completion of collection of the first tube.
measure: Number of attempts necessary for successful blood draw.
time frame: Less than 5 minutes
measure: Satisfaction evaluation
time frame: Less than 5 minutes
description: Satisfaction of phlebotomists and parents will be assessed by a Likert-type survey administered immediately after the blood draw
arm group label: Distraction
arm group type: Experimental
description: Patients randomized to the "Distraction" group will be permitted to choose an age appropriate application (e.g. movie, game) which will be held for them during the blood draw.
arm group label: Standard of care
arm group type: No Intervention
description: Patients randomized to the "Standard of Care" group will not be provided with an iPad.
intervention type: Other
intervention name: Distraction
description: Distraction will be provided by allowing the patient to will choose an age appropriate application (e.g. movie, game) which will be held for them during the blood draw.
arm group label: Distraction
other name: iPad
criteria: 
gender: All
minimum age: 4 Years
maximum age: 17 Years
healthy volunteers: No
last name: Daniel S Tsze, MD, MPH
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Daniel S Tsze, MD, MPH
investigator title: Assistant Professor of Pediatrics at the Columbia University Medical Center
mesh term: Pain, Procedural
sharing ipd: No