xml: <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/NCT06013501</url>
    </required_header>
    <id_info>
      <org_study_id>SC-puppet</org_study_id>
      <nct_id>NCT06013501</nct_id>
    </id_info>
    <brief_title>The Effect of Puppet Show on Pain and Fear During Subcutaneous Injection in Children With Leukemia</brief_title>
    <acronym>SC-puppet</acronym>
    <official_title>The Effect of Puppet Show on Pain and Fear During Subcutaneous Injection in Children With Leukemia: A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dokuz Eylul University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ege University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Dokuz Eylul 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>
        This study aim to evaluate the effect of puppet show applied during subcutaneous injection to&#xD;
        children aged 3-7 years with leukemia on the level of pain and fear experienced by children&#xD;
        due to the intervention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Before and during subcutaneous injection administration to the children in the study group&#xD;
        There will be a puppet show. No distraction method will be applied to the children in the&#xD;
        control group and the clinical A subcutaneous injection will be administered in accordance&#xD;
        with the routine. Pain and fear assessment of children in both groups will be evaluated by&#xD;
        the clinical nurse during the intervention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 3, 2023</start_date>
    <completion_date type="Anticipated">January 3, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 3, 2024</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>Crossover Assignment</intervention_model>
      <intervention_model_description>Randomised</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>procedure-related pain with Wong Baker Pain Rating Scale</measure>
      <time_frame>change from Wong Baker Pain Rating Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)</time_frame>
      <description>pain assessment with Wong Baker Pain Rating Scale by child</description>
    </primary_outcome>
    <primary_outcome>
      <measure>procedure-related fear with Child Fear Scale</measure>
      <time_frame>change from Child Fear Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)</time_frame>
      <description>fear assessment with Child Fear Scale by child and parent</description>
    </primary_outcome>
    <primary_outcome>
      <measure>procedure-related pain with The FLACC scale or Face, Legs, Activity, Cry, Consolability scale</measure>
      <time_frame>change from The FLACC scale or Face, Legs, Activity, Cry, Consolability scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)</time_frame>
      <description>pain assessment with The FLACC scale or Face, Legs, Activity, Cry, Consolability scale by nurse</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Heart rate</measure>
      <time_frame>change from the heart rate at 10 minutes</time_frame>
      <description>Heart rate measurement</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Pain, Acute</condition>
    <condition>Fear</condition>
    <arm_group>
      <arm_group_label>Puppet Show Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>puppet show before and during subcutaneous injection</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>standart care</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>puppet show</intervention_name>
      <description>puppet show to the child before and during subcutaneous application</description>
      <arm_group_label>Puppet Show Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Child &lt;3 and &gt;7 years old&#xD;
  &#xD;
            -  Medically unstable (dehydration, septic shock, sedation)&#xD;
  &#xD;
            -  Children who are being treated for leukemia in the Pediatric Hematology Service will&#xD;
               be included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not exposed to any other interventional procedure before (same day) subcutaneous&#xD;
               intervention&#xD;
  &#xD;
            -  Not expressing any pain before subcutaneous intervention&#xD;
  &#xD;
            -  Heart rate to be within age-appropriate limits&#xD;
  &#xD;
            -  Wong-Baker Pain Rating Scale score of 0 in the evaluation performed before the&#xD;
               subcutaneous intervention (5 minutes ago)&#xD;
  &#xD;
            -  Having a disability that cannot perceive the attempt and communicate (down syndrome,&#xD;
               speech disorder, visual impairment)&#xD;
  &#xD;
            -  The child and family do not know Turkish&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>7 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gülçin Özalp Gerçeker, pHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dokuz Eylul University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gülçin Özalp Gerçeker, pHD</last_name>
      <phone>905306411368</phone>
      <email>gulcinozalp@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Gülçin Özalp Gerçeker</name>
        <address>
          <city>İzmir</city>
          <zip>35100</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gülçin Ö Gerçeker</last_name>
        <phone>05306411368</phone>
        <email>gulcinozalp@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>March 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Dokuz Eylul University</investigator_affiliation>
      <investigator_full_name>Gülçin Özalp Gerçeker</investigator_full_name>
      <investigator_title>pHD, Assoc. Prof.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013501
  org study id: SC-puppet
  nct id: NCT06013501
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aim to evaluate the effect of puppet show applied during subcutaneous injection to
        children aged 3-7 years with leukemia on the level of pain and fear experienced by children
        due to the intervention.
  Before and during subcutaneous injection administration to the children in the study group
        There will be a puppet show. No distraction method will be applied to the children in the
        control group and the clinical A subcutaneous injection will be administered in accordance
        with the routine. Pain and fear assessment of children in both groups will be evaluated by
        the clinical nurse during the intervention.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Randomised
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  measure: procedure-related pain with Wong Baker Pain Rating Scale
  time frame: change from Wong Baker Pain Rating Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
  description: pain assessment with Wong Baker Pain Rating Scale by child
  measure: procedure-related fear with Child Fear Scale
  time frame: change from Child Fear Scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
  description: fear assessment with Child Fear Scale by child and parent
  measure: procedure-related pain with The FLACC scale or Face, Legs, Activity, Cry, Consolability scale
  time frame: change from The FLACC scale or Face, Legs, Activity, Cry, Consolability scale (5 minutes before the subcutaneous injection, 5 minutes after subcutaneous injection)
  description: pain assessment with The FLACC scale or Face, Legs, Activity, Cry, Consolability scale by nurse
  measure: Heart rate
  time frame: change from the heart rate at 10 minutes
  description: Heart rate measurement
  arm group label: Puppet Show Group
  arm group type: Experimental
  description: puppet show before and during subcutaneous injection
  arm group label: Control group
  arm group type: No Intervention
  description: standart care
  intervention type: Behavioral
  intervention name: puppet show
  description: puppet show to the child before and during subcutaneous application
  arm group label: Puppet Show Group
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: 7 Years
  healthy volunteers: No
  last name: Gülçin Özalp Gerçeker, pHD
  role: Principal Investigator
  affiliation: Dokuz Eylul University
  last name: Gülçin Özalp Gerçeker, pHD
  phone: 905306411368
  email: gulcinozalp@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Dokuz Eylul University
  investigator full name: Gülçin Özalp Gerçeker
  investigator title: pHD, Assoc. Prof.
  mesh term: Acute Pain
  sharing ipd: No