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/NCT06010771</url>
    </required_header>
    <id_info>
      <org_study_id>Pediatric Nursing</org_study_id>
      <nct_id>NCT06010771</nct_id>
    </id_info>
    <brief_title>The Effect of Listening to Stories and Watching Cartoon Film on Pain in the Aspiration Process in Children Receiving Palliative Care</brief_title>
    <official_title>The Effect of Listening to Stories and Watching Cartoon Film on Pain in the Aspiration Process in Playing Age Children Receiving Palliative Care: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gamze Akay</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ataturk University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Artvin Coruh University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to determine the effect of listening to fairy tales and watching&#xD;
        cartoons on pain in the aspiration process in play-age children receiving palliative care.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        15 voluntary children with receiving palliative care, aged between 1-3 years will be randomly&#xD;
        divided into two groups: fairy tale group and cartoon group. Interventions will be applied&#xD;
        for 3 weeks, 1 times a day (16 sessions). No intervention will be applied to both groups&#xD;
        besides fairy tale or cartoon intervention. The children will be assessed before, during and&#xD;
        after. PAIN DUE TO ASPIRATION PROCEDURE will be evaluated using the FLACC Pain Scale. In&#xD;
        addition, the heart rate, respiration, blood pressure, tidal volume and fever values of the&#xD;
        children will be measured with the help of a bedside monitor.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 20, 2023</start_date>
    <completion_date type="Anticipated">June 8, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 28, 2023</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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient Identification Form</measure>
      <time_frame>baseline</time_frame>
      <description>In this form, there are questions about the child's age, gender, diagnosis of the disease, length of stay, and how long ago she received the current diagnosis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physiological Parameter Record Form</measure>
      <time_frame>baseline and up to 4 weeks</time_frame>
      <description>In this form, there are records of all physiological parameters including pulse and respiratory rate, body temperature, blood pressure, SpO2, tidal volume, and peak heart rate. If the value of each parameter is higher than the normal values, it indicates the presence of abnormal condition.&#xD;
  Pulse normal value range: 80-130/ Minute Blood pressure normal value range:92-44 mmHg Respiratory rate normal value range: 16-22/ Minute Body temperature normal value range: 36,4-38 degree SpO2 normal value range: %96-98 Tidal volume normal value range: 6-10 ml/kg</description>
    </primary_outcome>
    <primary_outcome>
      <measure>FLACC Pain Scale</measure>
      <time_frame>baseline and up to 4 weeks</time_frame>
      <description>FLACC has reliability and validity to determine observational pain of children aged between 3 and 18 years during the medical procedures. This scale is preferred due to its implicity of application among children. It has five categories of behavior to rate pain, namely, facial expression, leg movement, activity, cry, and consolability. The scores of each category are between 0 and 2. The total scores can range from 0 to 10, defined as mild (1-3), moderate (4-6), and severe (7-10). The higher the score, the greater the pain.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">17</enrollment>
    <condition>Aspiration; Syndrome</condition>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Routine aspiration will be applied to the control group. No action will be taken.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>During the aspiration process, the experimental group will listen to fairy tales and watch cartoons.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Listening to fairy tales</intervention_name>
      <description>Fairy tales by children will be chosen by child psychologists. Tales will be read to the children by the researcher. The researcher has a fairy tale therapy certificate. The tale reading will start 5 minutes before the aspiration process and will continue throughout the aspiration process. Tales will be read to children every other day. This process will continue for 3 weeks.</description>
      <arm_group_label>Experimental Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Watching Cartoon Film</intervention_name>
      <description>The cartoons that children will watch will be preferred by child psychologists. Children will be watched cartoons with the help of tablets. Watching cartoons will start 5 minutes before the aspiration process and will continue throughout the aspiration process. Children will be shown cartoons every other day. This process will continue for 3 weeks.</description>
      <arm_group_label>Experimental Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being in the 1-3 age group&#xD;
  &#xD;
            -  Being in the palliative care service for at least 3 months&#xD;
  &#xD;
            -  Receiving inpatient treatment in the pediatric palliative care service&#xD;
  &#xD;
            -  Absence of visual and hearing anomalies&#xD;
  &#xD;
            -  No other chronic disease&#xD;
  &#xD;
            -  Having a tracheostomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  The family's desire to leave research.&#xD;
  &#xD;
            -  Deterioration of the child's condition&#xD;
  &#xD;
            -  The child's diagnosis of an additional chronic disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>3 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gamze AKAY, 1</last_name>
      <role>Principal Investigator</role>
      <affiliation>Artvin Coruh University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gamze AKAY, 1</last_name>
      <phone>05314536661</phone>
      <email>gamzeakay_25@artvin.edu.tr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Fatma GÜDÜCÜ TÜFEKCİ, 2</last_name>
      <phone>05314536661</phone>
      <email>fatma.guducutufekci@atauni.edu.tr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Erzurum City Hospital</name>
        <address>
          <city>Erzurum</city>
          <state>Central</state>
          <zip>25090</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <link>
      <url>http://pubmed.ncbi.nlm.nih.gov/36735635/</url>
      <description>A randomized controlled study</description>
    </link>
    <reference>
      <citation>Sarialioglu A, Kurudirek F, Oluc T. The effect of storybook reading on children's preoperative fear and anxiety levels: A randomized controlled study. Child Care Health Dev. 2023 Sep;49(5):906-913. doi: 10.1111/cch.13100. Epub 2023 Feb 8.</citation>
      <PMID>36735635</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Artvin Coruh University</investigator_affiliation>
      <investigator_full_name>Gamze Akay</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <keyword>Palliative care</keyword>
    <keyword>Children</keyword>
    <keyword>Listening to Stories</keyword>
    <keyword>Watching Cartoon Film</keyword>
    <keyword>Pain</keyword>
    <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/NCT06010771
  org study id: Pediatric Nursing
  nct id: NCT06010771
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to determine the effect of listening to fairy tales and watching
        cartoons on pain in the aspiration process in play-age children receiving palliative care.
  15 voluntary children with receiving palliative care, aged between 1-3 years will be randomly
        divided into two groups: fairy tale group and cartoon group. Interventions will be applied
        for 3 weeks, 1 times a day (16 sessions). No intervention will be applied to both groups
        besides fairy tale or cartoon intervention. The children will be assessed before, during and
        after. PAIN DUE TO ASPIRATION PROCEDURE will be evaluated using the FLACC Pain Scale. In
        addition, the heart rate, respiration, blood pressure, tidal volume and fever values of the
        children will be measured with the help of a bedside monitor.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Supportive Care
  masking: Double (Investigator, Outcomes Assessor)
  measure: Patient Identification Form
  time frame: baseline
  description: In this form, there are questions about the child's age, gender, diagnosis of the disease, length of stay, and how long ago she received the current diagnosis.
  measure: Physiological Parameter Record Form
  time frame: baseline and up to 4 weeks
  description: In this form, there are records of all physiological parameters including pulse and respiratory rate, body temperature, blood pressure, SpO2, tidal volume, and peak heart rate. If the value of each parameter is higher than the normal values, it indicates the presence of abnormal condition.
  Pulse normal value range: 80-130/ Minute Blood pressure normal value range:92-44 mmHg Respiratory rate normal value range: 16-22/ Minute Body temperature normal value range: 36,4-38 degree SpO2 normal value range: %96-98 Tidal volume normal value range: 6-10 ml/kg
  measure: FLACC Pain Scale
  time frame: baseline and up to 4 weeks
  description: FLACC has reliability and validity to determine observational pain of children aged between 3 and 18 years during the medical procedures. This scale is preferred due to its implicity of application among children. It has five categories of behavior to rate pain, namely, facial expression, leg movement, activity, cry, and consolability. The scores of each category are between 0 and 2. The total scores can range from 0 to 10, defined as mild (1-3), moderate (4-6), and severe (7-10). The higher the score, the greater the pain.
  arm group label: Control Group
  arm group type: No Intervention
  description: Routine aspiration will be applied to the control group. No action will be taken.
  arm group label: Experimental Group
  arm group type: Experimental
  description: During the aspiration process, the experimental group will listen to fairy tales and watch cartoons.
  intervention type: Other
  intervention name: Listening to fairy tales
  description: Fairy tales by children will be chosen by child psychologists. Tales will be read to the children by the researcher. The researcher has a fairy tale therapy certificate. The tale reading will start 5 minutes before the aspiration process and will continue throughout the aspiration process. Tales will be read to children every other day. This process will continue for 3 weeks.
  arm group label: Experimental Group
  intervention type: Other
  intervention name: Watching Cartoon Film
  description: The cartoons that children will watch will be preferred by child psychologists. Children will be watched cartoons with the help of tablets. Watching cartoons will start 5 minutes before the aspiration process and will continue throughout the aspiration process. Children will be shown cartoons every other day. This process will continue for 3 weeks.
  arm group label: Experimental Group
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: 3 Years
  healthy volunteers: No
  last name: Gamze AKAY, 1
  role: Principal Investigator
  affiliation: Artvin Coruh University
  last name: Gamze AKAY, 1
  phone: 05314536661
  email: gamzeakay_25@artvin.edu.tr
  last name: Fatma GÜDÜCÜ TÜFEKCİ, 2
  phone: 05314536661
  email: fatma.guducutufekci@atauni.edu.tr
  facility: 
  country: Turkey
  url: http://pubmed.ncbi.nlm.nih.gov/36735635/
  description: A randomized controlled study
  citation: Sarialioglu A, Kurudirek F, Oluc T. The effect of storybook reading on children's preoperative fear and anxiety levels: A randomized controlled study. Child Care Health Dev. 2023 Sep;49(5):906-913. doi: 10.1111/cch.13100. Epub 2023 Feb 8.
  PMID: 36735635
  responsible party type: Sponsor-Investigator
  investigator affiliation: Artvin Coruh University
  investigator full name: Gamze Akay
  investigator title: Lecturer
  sharing ipd: No