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/NCT05974319</url>
    </required_header>
    <id_info>
      <org_study_id>GHF_MC1</org_study_id>
      <nct_id>NCT05974319</nct_id>
    </id_info>
    <brief_title>The Effect of Dry Heat and Dry Cold Application on Blood Sampling in Children</brief_title>
    <official_title>The Effect of Dry Heat and Dry Cold Application on Pain, Anxiety and Fear Levels Before Blood Sample Collection in School Age Children: A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Saglik Bilimleri Universitesi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Saglik Bilimleri Universitesi</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>
        The study was conducted as a parallel group randomized controlled in order to determine the&#xD;
        effects of dry heat and dry cold application before blood collection in school-aged children&#xD;
        (7-12 years old) on pain, anxiety and fear levels.&#xD;
  &#xD;
        Participants were randomly assigned to experiment 1-dry hot application group, experiment&#xD;
        2-dry cold application group and control group.&#xD;
  &#xD;
        In Experiment 1-Dry Heat Application group, a dry heat of 42°C was applied to the determined&#xD;
        area with an electrical heating pad for 5 minutes before blood sample was taken.&#xD;
  &#xD;
        In Experiment 2-Dry Cold Application group, dry cold was applied to the area determined with&#xD;
        a gel pad for 3 minutes before blood sample was taken.&#xD;
  &#xD;
        In the Control group, blood sampling was performed according to the clinical routine, and no&#xD;
        heat or cold application was made.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Prior to blood sampling, parents and children were initially informed about the study in&#xD;
        Experiment 1-dry heat, Experiment 2-dry cold, and control groups, and their written and&#xD;
        verbal consents were obtained. After obtaining consent, information about the child and&#xD;
        family was collected by the researcher with the &quot;Child-Family Introductory Information Form&quot;&#xD;
        before the procedure. After the family and the child were introduced to the measurement tools&#xD;
        (Wong Baker Faces Pain Scale, Child Fair Anxiety Scale and Medical Procedures Fear Inventory)&#xD;
        to be scored, it was explained to the child that his mother or father would be with him&#xD;
        during the procedure, and he was taken to the intervention room. Before the blood sample&#xD;
        collection, the child's fear and anxiety were evaluated using Child Fear Anxiety Scale.&#xD;
  &#xD;
        In Experiment 1-Dry Heat Application group, the electrical heating pad with temperature&#xD;
        regulation was heated by the researcher and set to 42°C. After making sure that there were no&#xD;
        contraindications (deterioration of skin integrity, etc.) in the application of the&#xD;
        electrical heating pad device, a dry heat of 42°C was applied to the determined area with an&#xD;
        electrical heating pad for 5 minutes.&#xD;
  &#xD;
        In Experiment 2-Dry Cold Application group, dry cold was applied to the determined area with&#xD;
        a gel pad for 3 minutes after the researcher made sure that there were no contraindications&#xD;
        (deterioration of skin integrity, etc.) in the application of the gel pad.&#xD;
  &#xD;
        In the Control group, blood sampling was performed according to the clinical routine, and no&#xD;
        heat or cold application was made.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 11, 2021</start_date>
    <completion_date type="Actual">December 29, 2021</completion_date>
    <primary_completion_date type="Actual">December 29, 2021</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>
      <intervention_model_description>Before blood sampling, the participants were assigned to the experiment 1-dry heat application, experiment 2-dry cold application and control groups.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Wong Baker Faces Pain Rating Scale</measure>
      <time_frame>One minutes after blood sampling; once</time_frame>
      <description>Refers to the pain felt due to the blood sample collection process.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Child Fear Scale</measure>
      <time_frame>Two minutes before blood sampling, Two minutes after blood sampling; twice.</time_frame>
      <description>It expresses the fear of taking a blood sample, which is a painful procedure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Child Anxiety Scale</measure>
      <time_frame>Two minutes before blood sampling, two minutes after blood sampling; twice.</time_frame>
      <description>It expresses the anxiety of taking a blood sample, which is a painful procedure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Medical Procedures Fear Inventory</measure>
      <time_frame>Three minutes after blood sampling; once.</time_frame>
      <description>It refers to evaluating children's fears towards medical interventions.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">120</enrollment>
    <condition>School Age Children</condition>
    <condition>Blood</condition>
    <condition>Procedural Pain</condition>
    <condition>Procedural Anxiety</condition>
    <condition>Fear</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>During the blood sample collection, the application was carried out in line with the routine care.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dry heat application</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The region where the invasive intervention will be performed will be determined by the nurse in charge of the shift. The researcher will heat the thermoregulated electric pad and set it to 42°C. After making sure that there are no contraindications in the application of the electric pad device, a dry heat of 42°C will be applied to the determined area with the electric pad for 5 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dry cold application</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The region where the invasive intervention will be performed will be determined by the nurse in charge of the shift. After the researcher is sure that there are no contraindications in the application of the gel pad, dry cold will be applied to the determined area with the gel pad for 3 minutes.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Dry heat application</intervention_name>
      <description>Dry heat application: The region where the invasive intervention will be performed will be determined by the nurse in charge of the shift. The researcher will heat the thermoregulated electric pad and set it to 42°C. After making sure that there are no contraindications in the application of the electric pad device, a dry heat of 42°C will be applied to the determined area with the electric pad for 5 minutes.</description>
      <arm_group_label>Dry heat application</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Dry cold application</intervention_name>
      <description>Dry cold applicaiton: The region where the invasive intervention will be performed will be determined by the nurse in charge of the shift. After the researcher is sure that there are no contraindications in the application of the gel pad, dry cold will be applied to the determined area with the gel pad for 3 minutes.</description>
      <arm_group_label>Dry cold application</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  7-12 years old&#xD;
  &#xD;
            -  Absence of physical and mental illness&#xD;
  &#xD;
            -  Absence of auditory, visual and verbal speech disability&#xD;
  &#xD;
            -  Parents' willingness to participate in the research, and signing the volunteer form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those who do not meet the inclusion criteria&#xD;
  &#xD;
            -  Those who do not volunteer to participate&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Berna Eren Fidancı, RA</last_name>
      <role>Study Director</role>
      <affiliation>University of Sağlık Bilimleri</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Sağlık Bilimleri University Gulhane Training and Research Hospital</name>
        <address>
          <city>Ankara</city>
          <state>Keçiören</state>
          <zip>06010</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Saglik Bilimleri Universitesi</investigator_affiliation>
      <investigator_full_name>Berna Eren Fidancı</investigator_full_name>
      <investigator_title>Associate professor</investigator_title>
    </responsible_party>
    <keyword>Blood sampling</keyword>
    <keyword>Children</keyword>
    <keyword>Dry heat</keyword>
    <keyword>Dry cold</keyword>
    <keyword>Pediatric nurse</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Procedural</mesh_term>
    </condition_browse>
    <!-- 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/NCT05974319
  org study id: GHF_MC1
  nct id: NCT05974319
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study was conducted as a parallel group randomized controlled in order to determine the
        effects of dry heat and dry cold application before blood collection in school-aged children
        (7-12 years old) on pain, anxiety and fear levels.
  
        Participants were randomly assigned to experiment 1-dry hot application group, experiment
        2-dry cold application group and control group.
  
        In Experiment 1-Dry Heat Application group, a dry heat of 42°C was applied to the determined
        area with an electrical heating pad for 5 minutes before blood sample was taken.
  
        In Experiment 2-Dry Cold Application group, dry cold was applied to the area determined with
        a gel pad for 3 minutes before blood sample was taken.
  
        In the Control group, blood sampling was performed according to the clinical routine, and no
        heat or cold application was made.
  Prior to blood sampling, parents and children were initially informed about the study in
        Experiment 1-dry heat, Experiment 2-dry cold, and control groups, and their written and
        verbal consents were obtained. After obtaining consent, information about the child and
        family was collected by the researcher with the "Child-Family Introductory Information Form"
        before the procedure. After the family and the child were introduced to the measurement tools
        (Wong Baker Faces Pain Scale, Child Fair Anxiety Scale and Medical Procedures Fear Inventory)
        to be scored, it was explained to the child that his mother or father would be with him
        during the procedure, and he was taken to the intervention room. Before the blood sample
        collection, the child's fear and anxiety were evaluated using Child Fear Anxiety Scale.
  
        In Experiment 1-Dry Heat Application group, the electrical heating pad with temperature
        regulation was heated by the researcher and set to 42°C. After making sure that there were no
        contraindications (deterioration of skin integrity, etc.) in the application of the
        electrical heating pad device, a dry heat of 42°C was applied to the determined area with an
        electrical heating pad for 5 minutes.
  
        In Experiment 2-Dry Cold Application group, dry cold was applied to the determined area with
        a gel pad for 3 minutes after the researcher made sure that there were no contraindications
        (deterioration of skin integrity, etc.) in the application of the gel pad.
  
        In the Control group, blood sampling was performed according to the clinical routine, and no
        heat or cold application was made.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Before blood sampling, the participants were assigned to the experiment 1-dry heat application, experiment 2-dry cold application and control groups.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Wong Baker Faces Pain Rating Scale
  time frame: One minutes after blood sampling; once
  description: Refers to the pain felt due to the blood sample collection process.
  measure: Child Fear Scale
  time frame: Two minutes before blood sampling, Two minutes after blood sampling; twice.
  description: It expresses the fear of taking a blood sample, which is a painful procedure.
  measure: Child Anxiety Scale
  time frame: Two minutes before blood sampling, two minutes after blood sampling; twice.
  description: It expresses the anxiety of taking a blood sample, which is a painful procedure.
  measure: Medical Procedures Fear Inventory
  time frame: Three minutes after blood sampling; once.
  description: It refers to evaluating children's fears towards medical interventions.
  arm group label: Control group
  arm group type: No Intervention
  description: During the blood sample collection, the application was carried out in line with the routine care.
  arm group label: Dry heat application
  arm group type: Experimental
  description: The region where the invasive intervention will be performed will be determined by the nurse in charge of the shift. The researcher will heat the thermoregulated electric pad and set it to 42°C. After making sure that there are no contraindications in the application of the electric pad device, a dry heat of 42°C will be applied to the determined area with the electric pad for 5 minutes.
  arm group label: Dry cold application
  arm group type: Experimental
  description: The region where the invasive intervention will be performed will be determined by the nurse in charge of the shift. After the researcher is sure that there are no contraindications in the application of the gel pad, dry cold will be applied to the determined area with the gel pad for 3 minutes.
  intervention type: Other
  intervention name: Dry heat application
  description: Dry heat application: The region where the invasive intervention will be performed will be determined by the nurse in charge of the shift. The researcher will heat the thermoregulated electric pad and set it to 42°C. After making sure that there are no contraindications in the application of the electric pad device, a dry heat of 42°C will be applied to the determined area with the electric pad for 5 minutes.
  arm group label: Dry heat application
  intervention type: Other
  intervention name: Dry cold application
  description: Dry cold applicaiton: The region where the invasive intervention will be performed will be determined by the nurse in charge of the shift. After the researcher is sure that there are no contraindications in the application of the gel pad, dry cold will be applied to the determined area with the gel pad for 3 minutes.
  arm group label: Dry cold application
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: Berna Eren Fidancı, RA
  role: Study Director
  affiliation: University of Sağlık Bilimleri
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Saglik Bilimleri Universitesi
  investigator full name: Berna Eren Fidancı
  investigator title: Associate professor
  mesh term: Pain, Procedural