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/NCT05964426</url>
    </required_header>
    <id_info>
      <org_study_id>HealthLiteracy</org_study_id>
      <nct_id>NCT05964426</nct_id>
    </id_info>
    <brief_title>Health Literacy of Parents Regarding Neonatal Jaundice</brief_title>
    <official_title>Health Literacy of Parents Regarding Neonatal Jaundice: A Relational Descriptive Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ege University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Associate Professor Figen YARDIMCI</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ege 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 will be conducted as a relational descriptive study to determine the health&#xD;
        literacy level of parents with infants between 0-28 days of age regarding neonatal jaundice.&#xD;
        The secondary aim of the study is to examine whether the health literacy levels of the&#xD;
        parents differ with parent and infant descriptive characteristics and their knowledge about&#xD;
        neonatal jaundice. In this study, answers to the following questions were sought.&#xD;
  &#xD;
          1. What is the level of knowledge about neonatal jaundice among parents with infants&#xD;
             between 0-28 days?&#xD;
  &#xD;
          2. What is the level of health literacy of parents with infants between 0-28 days of age&#xD;
             and is there a relationship between parent, infant identifying characteristics and&#xD;
             knowledge about neonatal jaundice?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objective: This study will be conducted as a relational descriptive study to determine the&#xD;
        health literacy level of parents with infants between 0-28 days of age regarding neonatal&#xD;
        jaundice. The secondary aim of the study is to examine whether the health literacy levels of&#xD;
        the parents differ with parent and infant descriptive characteristics and their knowledge&#xD;
        about neonatal jaundice.&#xD;
  &#xD;
        Methodology of the research: The research is a descriptive study in relational design. It is&#xD;
        a study design in which the relationships between two or more variables are examined, aiming&#xD;
        to examine whether one variable causes any change in the other variable.&#xD;
  &#xD;
        Population of the Study: Parents with newborns between 0-28 days who applied to Beyşehir&#xD;
        State Hospital, Pediatric Polyclinics.&#xD;
  &#xD;
        While determining the sample of the study; using G-Power 3.1.9.7 program; type 1 error (α)&#xD;
        0.05, power (1- β) 80% and Cohen's effect size (δ) 0.2, the sample size to represent the main&#xD;
        mass was determined as 156 people for this study. However, when the dropout rate is set as&#xD;
        10% for data loss that may occur in the study, the minimum number to be reached for the study&#xD;
        is targeted as 170 people.&#xD;
  &#xD;
        In order to reach the sample size, random sampling method, which is one of the&#xD;
        non-probability sampling methods, will be used. In this method, a part of the universe is&#xD;
        reached in any way according to the sample size determined by the researcher.&#xD;
  &#xD;
        Independent Variables: The independent variables of the study included age, education level,&#xD;
        family type, place of residence, whether the parents had other children, how many days old&#xD;
        the baby was, gender of the baby, blood type of the mother, father and baby, whether the baby&#xD;
        was given formula in addition, whether the parents had sufficient information about neonatal&#xD;
        jaundice, from whom they received the information, what their reaction would be if their baby&#xD;
        got jaundice, information about the causes, symptoms and complications of jaundice.&#xD;
  &#xD;
        Dependent Variables: The mean score of the health literacy scale of the parents constituted&#xD;
        the dependent variables.&#xD;
  &#xD;
        The research data will be collected through the 'Introductory Information Form on Mother and&#xD;
        Infant (Appendix 1)', 'Parent Information Form on Neonatal Jaundice (Appendix 2)' and 'Turkey&#xD;
        Health Literacy Scale (Appendix 3)' which were created by the researcher using the&#xD;
        literature.&#xD;
  &#xD;
        Data Analysis: Statistical Package for Social Sciences (SPSS) 25.0 package program will be&#xD;
        used to analyze the data. Descriptive characteristics of the parents will be given as&#xD;
        frequency (f), percentage (%) and mean. Normality distribution will be determined by&#xD;
        Shapiro-Wilk test. In the analysis of normally distributed data; t-test will be used to&#xD;
        determine whether there is a difference between two independent groups, and one-way (Oneway)&#xD;
        ANOVA will be used to determine whether there is a difference between more than two&#xD;
        independent groups. In the analysis of non-normally distributed data, Mann Whitney-U will be&#xD;
        used to determine whether there is a difference between two independent groups and one-way&#xD;
        Kruskall-Wallis will be used to determine whether there is a difference between more than two&#xD;
        independent groups. The findings obtained will be evaluated at 95% confidence interval and&#xD;
        significance at p&lt;0.05 level.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>It is planned as a relational descriptive study to determine the level of health literacy of parents with babies between 0-28 days of age regarding neonatal jaundice.</measure>
      <time_frame>August 1 2023 - December 31 2023</time_frame>
      <description>To determine the health literacy levels of parents with 0-28 days old babies regarding neonatal jaundice. Accordingly, the scores of the Turkish Health Literacy Scale (TSOY-32) are given below.&#xD;
  (0-25) points: insufficient health literacy&#xD;
  (&gt;25-33) score: problematic - limited health literacy&#xD;
  (&gt;33-42) score: adequate health literacy&#xD;
  (&gt;42-50) score: excellent health literacy</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The secondary aim of the study was to examine whether parents' health literacy levels differed with parent and infant descriptive characteristics and knowledge about neonatal jaundice.</measure>
      <time_frame>August 1 2023- December 312023</time_frame>
      <description>The secondary aim of the study is to examine whether the health literacy levels of the parents [Turkish Health Literacy Scale (TSOY-32)] differ according to their parental and infant descriptive characteristics and their knowledge about neonatal jaundice (significance p&lt;0.05).</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">170</enrollment>
    <condition>Unspecified Fetal and Neonatal Jaundice</condition>
    <arm_group>
      <arm_group_label>Parent and Infant Information Form</arm_group_label>
      <description>This form consists of a total of 19 questions in line with the literature, including the parents' age, education level, family type, place of residence, whether they have other children, how many days their baby is, gender of the baby, maternal blood type, paternal blood type, and whether the baby is given formula in addition.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Parent Information Form on Neonatal Jaundice</arm_group_label>
      <description>This form consists of a total of 6 questions in line with the literature, including whether the parent has sufficient information about neonatal jaundice, from whom he/she received the information, what his/her reaction will be if his/her baby gets jaundice, and information about the causes, symptoms and side effects of jaundice.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Turkey Health Literacy Scale (TSOY-32)</arm_group_label>
      <description>It is a 32-question scale developed based on the Conceptual Framework of the European Health Literacy Scale Study. The Turkish Health Literacy Scale (TSOY-32) was developed to assess health literacy in literate people over the age of fifteen. Unlike the original scale, the scale consists of eight components including two dimensions (treatment and service, disease prevention and health promotion) and four processes (accessing health-related information, understanding health-related information, evaluating health-related information, and using/applying health-related information). The overall internal consistency coefficient of the scale was 0.92. The Cronbach's alpha coefficient of the first dimension 'Treatment and Service Subdimension' is 0.88. The Cronbach's alpha coefficient of the second dimension 'Disease Prevention and Health Promotion Dimension' is 0.86. Permission to use the scale was obtained.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Turkey Health Literacy Scale (TSOY-32)</intervention_name>
      <description>A survey will be conducted.</description>
      <arm_group_label>Parent Information Form on Neonatal Jaundice</arm_group_label>
      <arm_group_label>Parent and Infant Information Form</arm_group_label>
      <arm_group_label>Turkey Health Literacy Scale (TSOY-32)</arm_group_label>
      <other_name>Parent and Infant Information Form</other_name>
      <other_name>Parent Information Form on Neonatal Jaundice</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          It will be carried out with parents who have a newborn between 0-28 days who applied to&#xD;
          Beyşehir State Hospital, Pediatrics Polyclinics.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Theparent has a baby aged 0-28 days, The parent does not have any&#xD;
               speech-vision-hearing disability that would prevent communication,&#xD;
  &#xD;
            -  The parent speaks Turkish,&#xD;
  &#xD;
            -  Parental literacy&#xD;
  &#xD;
            -  It was determined by taking into consideration the criteria of volunteering to&#xD;
               participate in the research.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -Parents who do not meet the inclusion criteria will be excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 22, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ege University</investigator_affiliation>
      <investigator_full_name>Tuba GIYNAS</investigator_full_name>
      <investigator_title>clinical nurse</investigator_title>
    </responsible_party>
    <keyword>Health literacy</keyword>
    <keyword>neonatal jaundice</keyword>
    <keyword>newborn</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Jaundice, Neonatal</mesh_term>
      <mesh_term>Jaundice</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/NCT05964426
  org study id: HealthLiteracy
  nct id: NCT05964426
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study will be conducted as a relational descriptive study to determine the health
        literacy level of parents with infants between 0-28 days of age regarding neonatal jaundice.
        The secondary aim of the study is to examine whether the health literacy levels of the
        parents differ with parent and infant descriptive characteristics and their knowledge about
        neonatal jaundice. In this study, answers to the following questions were sought.
  
          1. What is the level of knowledge about neonatal jaundice among parents with infants
             between 0-28 days?
  
          2. What is the level of health literacy of parents with infants between 0-28 days of age
             and is there a relationship between parent, infant identifying characteristics and
             knowledge about neonatal jaundice?
  Objective: This study will be conducted as a relational descriptive study to determine the
        health literacy level of parents with infants between 0-28 days of age regarding neonatal
        jaundice. The secondary aim of the study is to examine whether the health literacy levels of
        the parents differ with parent and infant descriptive characteristics and their knowledge
        about neonatal jaundice.
  
        Methodology of the research: The research is a descriptive study in relational design. It is
        a study design in which the relationships between two or more variables are examined, aiming
        to examine whether one variable causes any change in the other variable.
  
        Population of the Study: Parents with newborns between 0-28 days who applied to Beyşehir
        State Hospital, Pediatric Polyclinics.
  
        While determining the sample of the study; using G-Power 3.1.9.7 program; type 1 error (α)
        0.05, power (1- β) 80% and Cohen's effect size (δ) 0.2, the sample size to represent the main
        mass was determined as 156 people for this study. However, when the dropout rate is set as
        10% for data loss that may occur in the study, the minimum number to be reached for the study
        is targeted as 170 people.
  
        In order to reach the sample size, random sampling method, which is one of the
        non-probability sampling methods, will be used. In this method, a part of the universe is
        reached in any way according to the sample size determined by the researcher.
  
        Independent Variables: The independent variables of the study included age, education level,
        family type, place of residence, whether the parents had other children, how many days old
        the baby was, gender of the baby, blood type of the mother, father and baby, whether the baby
        was given formula in addition, whether the parents had sufficient information about neonatal
        jaundice, from whom they received the information, what their reaction would be if their baby
        got jaundice, information about the causes, symptoms and complications of jaundice.
  
        Dependent Variables: The mean score of the health literacy scale of the parents constituted
        the dependent variables.
  
        The research data will be collected through the 'Introductory Information Form on Mother and
        Infant (Appendix 1)', 'Parent Information Form on Neonatal Jaundice (Appendix 2)' and 'Turkey
        Health Literacy Scale (Appendix 3)' which were created by the researcher using the
        literature.
  
        Data Analysis: Statistical Package for Social Sciences (SPSS) 25.0 package program will be
        used to analyze the data. Descriptive characteristics of the parents will be given as
        frequency (f), percentage (%) and mean. Normality distribution will be determined by
        Shapiro-Wilk test. In the analysis of normally distributed data; t-test will be used to
        determine whether there is a difference between two independent groups, and one-way (Oneway)
        ANOVA will be used to determine whether there is a difference between more than two
        independent groups. In the analysis of non-normally distributed data, Mann Whitney-U will be
        used to determine whether there is a difference between two independent groups and one-way
        Kruskall-Wallis will be used to determine whether there is a difference between more than two
        independent groups. The findings obtained will be evaluated at 95% confidence interval and
        significance at p<0.05 level.
  observational model: Other
  time perspective: Cross-Sectional
  measure: It is planned as a relational descriptive study to determine the level of health literacy of parents with babies between 0-28 days of age regarding neonatal jaundice.
  time frame: August 1 2023 - December 31 2023
  description: To determine the health literacy levels of parents with 0-28 days old babies regarding neonatal jaundice. Accordingly, the scores of the Turkish Health Literacy Scale (TSOY-32) are given below.
  (0-25) points: insufficient health literacy
  (>25-33) score: problematic - limited health literacy
  (>33-42) score: adequate health literacy
  (>42-50) score: excellent health literacy
  measure: The secondary aim of the study was to examine whether parents' health literacy levels differed with parent and infant descriptive characteristics and knowledge about neonatal jaundice.
  time frame: August 1 2023- December 312023
  description: The secondary aim of the study is to examine whether the health literacy levels of the parents [Turkish Health Literacy Scale (TSOY-32)] differ according to their parental and infant descriptive characteristics and their knowledge about neonatal jaundice (significance p<0.05).
  arm group label: Parent and Infant Information Form
  description: This form consists of a total of 19 questions in line with the literature, including the parents' age, education level, family type, place of residence, whether they have other children, how many days their baby is, gender of the baby, maternal blood type, paternal blood type, and whether the baby is given formula in addition.
  arm group label: Parent Information Form on Neonatal Jaundice
  description: This form consists of a total of 6 questions in line with the literature, including whether the parent has sufficient information about neonatal jaundice, from whom he/she received the information, what his/her reaction will be if his/her baby gets jaundice, and information about the causes, symptoms and side effects of jaundice.
  arm group label: Turkey Health Literacy Scale (TSOY-32)
  description: It is a 32-question scale developed based on the Conceptual Framework of the European Health Literacy Scale Study. The Turkish Health Literacy Scale (TSOY-32) was developed to assess health literacy in literate people over the age of fifteen. Unlike the original scale, the scale consists of eight components including two dimensions (treatment and service, disease prevention and health promotion) and four processes (accessing health-related information, understanding health-related information, evaluating health-related information, and using/applying health-related information). The overall internal consistency coefficient of the scale was 0.92. The Cronbach's alpha coefficient of the first dimension 'Treatment and Service Subdimension' is 0.88. The Cronbach's alpha coefficient of the second dimension 'Disease Prevention and Health Promotion Dimension' is 0.86. Permission to use the scale was obtained.
  intervention type: Other
  intervention name: Turkey Health Literacy Scale (TSOY-32)
  description: A survey will be conducted.
  arm group label: Parent Information Form on Neonatal Jaundice
  arm group label: Parent and Infant Information Form
  arm group label: Turkey Health Literacy Scale (TSOY-32)
  other name: Parent and Infant Information Form
  other name: Parent Information Form on Neonatal Jaundice
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Ege University
  investigator full name: Tuba GIYNAS
  investigator title: clinical nurse
  mesh term: Jaundice, Neonatal
  mesh term: Jaundice
  sharing ipd: No