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/NCT06027359</url>
    </required_header>
    <id_info>
      <org_study_id>AdnanMU-ÇSHH-FKD-01</org_study_id>
      <nct_id>NCT06027359</nct_id>
    </id_info>
    <brief_title>The Effect of therapeutıc Game on Preschool chıldren</brief_title>
    <official_title>The Effect of therapeutıc Game on nursıng ınıtıatıves and Fears of medıcal materıals ın Preschool chıldren</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aydin Adnan Menderes University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Aydin Adnan Menderes 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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        In processes such as illness, hospital, medical procedures, and nursing interventions, the&#xD;
        fears experienced by children should be reduced before the procedure. It may be more&#xD;
        effective to give interventions to reduce children's fears in a school setting rather than in&#xD;
        a complex environment such as a hospital. In this context, there is a need for experimental&#xD;
        studies that reveal the effect of therapeutic play on nursing interventions and fear of&#xD;
        medical materials in preschool children.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Entrance: In processes such as illness, hospital, medical procedures, and nursing&#xD;
        interventions, the fears experienced by children should be reduced before the procedure. It&#xD;
        may be more effective to give interventions to reduce children's fears in a school setting&#xD;
        rather than in a complex environment such as a hospital. In this context, there is a need for&#xD;
        experimental studies that reveal the effect of therapeutic play on nursing interventions and&#xD;
        fear of medical materials in preschool children.&#xD;
  &#xD;
        Aim: This study was planned to determine the effect of therapeutic play on nursing&#xD;
        interventions and fear of medical materials in preschool children.&#xD;
  &#xD;
        Method/ Data Collection Techniques:This research was planned as a quasi-experimental study&#xD;
        with pretest-posttest and control group. The universe of the research will consist of 170&#xD;
        children studying in pre-school classes at the Chamber of Commerce Primary School located in&#xD;
        the city center of Aydın. The sample size of the study was calculated using G*power analysis&#xD;
        and it was found that a total of 70 children (study: 35 children, control: 35 children).&#xD;
        However, considering the losses from the research and the possibility of children filling in&#xD;
        the questionnaires incomplete or incorrectly, the number of children was increased by 10% and&#xD;
        it was planned to complete the study with 80 (study: 40 children, control: 40 children)&#xD;
        children. It is planned to collect the data between March 1 and June 1, 2023. The child to be&#xD;
        included in the study and their parents will be informed about the study, verbal consent will&#xD;
        be obtained from the children and written consent will be obtained from the parents. After&#xD;
        obtaining parental consent about the study, the parents of the children in both the study and&#xD;
        control groups will have to fill in the &quot;Introductory Information Form&quot; and the children will&#xD;
        fill in the &quot;Scale of Fear of Nursing Interventions and Used Materials in Children&quot; before&#xD;
        the therapeutic play. The therapeutic game content to be applied to the study group consists&#xD;
        of four sessions organized by considering nursing interventions and materials used in the&#xD;
        hospital. In each session, various game activities will be held with different materials.&#xD;
        Therapeutic play activity will not be planned for the children in the control group. One week&#xD;
        after the therapeutic play activities are completed, the children will have to fill out the&#xD;
        &quot;Scale of Fear Against Nursing Interventions and Used Materials in Children&quot;.&#xD;
  &#xD;
        The data obtained in the research will be analyzed using the SPSS (Statistical Package for&#xD;
        Social Sciences) for Windows 22.0 program. Homogeneity of descriptive features between groups&#xD;
        will be tested by chi-square analysis. The Kolmogorov Smirnov Test will be used to determine&#xD;
        whether the research data are normally distributed. In the analysis of study data,&#xD;
        descriptive statistics, if the data show normal distribution, independent group-t-test and&#xD;
        changes within the group repeated measurements Anova test; If it does not have a normal&#xD;
        distribution, Mann Whitney-U test and Wilcoxon signed-rank test will be used.&#xD;
  &#xD;
        Expected Results: Thanks to the results obtained from this study, it is expected that the&#xD;
        familiarity of children with nursing interventions and materials with the therapeutic play&#xD;
        method in their own environment such as school will help them experience less fear and adapt&#xD;
        easily during a possible hospital experience in the future.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Actual">June 1, 2023</completion_date>
    <primary_completion_date type="Actual">May 1, 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>Health Services Research</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Nursing interventions and fear of materials used in children scale</measure>
      <time_frame>baseline and week 4</time_frame>
      <description>I am not afraid (1) I am extremely afraid (5). As the score increases, fear increases.</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">80</enrollment>
    <condition>Fear</condition>
    <condition>Nurse</condition>
    <condition>Hospital</condition>
    <arm_group>
      <arm_group_label>Therapeutic game to reduce fear of hospital and ambulance</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>therapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Therapeutic game to reduce fear of injectors and eye drops</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>therapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Therapeutic play to reduce fear of intrauterine and serum</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>therapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Therapeutic play to reduce fear of EKG and EMG</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>therapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Therapeutic play hospital fear and nursing interventions</intervention_name>
      <description>Children assigned to the study group will be divided into 5 groups, with a maximum of 8 children. The researcher will perform a therapeutic play activity with each group consisting of maximum 8 children one day of the week in the room and time determined by the school. Each activity will last an average of 30 minutes. Therapeutic play activities will be completed in 4 weeks.&#xD;
  Therapeutic play activities will not be performed with the children in the control group.&#xD;
  One week after the completion of the therapeutic play intervention, the researcher will re-fill the Child Nursing Interventions and Fear of Materials Scale-uncommon materials sub-dimension face-to-face with the children in the study and control groups.</description>
      <arm_group_label>Therapeutic game to reduce fear of hospital and ambulance</arm_group_label>
      <arm_group_label>Therapeutic game to reduce fear of injectors and eye drops</arm_group_label>
      <arm_group_label>Therapeutic play to reduce fear of EKG and EMG</arm_group_label>
      <arm_group_label>Therapeutic play to reduce fear of intrauterine and serum</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Child's:&#xD;
  &#xD;
            -  Between 60 months and 71 months (children over 71 months are educated in the first&#xD;
               grade of primary education).&#xD;
  &#xD;
            -  Having pre-school education&#xD;
  &#xD;
            -  Absence of any mental and/or physical health problems that would prevent communication&#xD;
               belonging to the parent. Belonging to the parent;&#xD;
  &#xD;
            -  Literacy of the parents&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          The child has any phobia or is receiving treatment for this issue.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Months</minimum_age>
      <maximum_age>71 Months</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Filiz KARACA DEVELİ</last_name>
      <role>Principal Investigator</role>
      <affiliation>Aydin Adnan Menderes University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Filiz KARACA DEVELİ</name>
        <address>
          <city>Efeler</city>
          <state>Aydın</state>
          <zip>09100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Aydin Adnan Menderes University</investigator_affiliation>
      <investigator_full_name>Filiz KARACA DEVELİ</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Fear, hospital, nurse, play therapy, preschool</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/NCT06027359
  org study id: AdnanMU-ÇSHH-FKD-01
  nct id: NCT06027359
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  In processes such as illness, hospital, medical procedures, and nursing interventions, the
        fears experienced by children should be reduced before the procedure. It may be more
        effective to give interventions to reduce children's fears in a school setting rather than in
        a complex environment such as a hospital. In this context, there is a need for experimental
        studies that reveal the effect of therapeutic play on nursing interventions and fear of
        medical materials in preschool children.
  Entrance: In processes such as illness, hospital, medical procedures, and nursing
        interventions, the fears experienced by children should be reduced before the procedure. It
        may be more effective to give interventions to reduce children's fears in a school setting
        rather than in a complex environment such as a hospital. In this context, there is a need for
        experimental studies that reveal the effect of therapeutic play on nursing interventions and
        fear of medical materials in preschool children.
  
        Aim: This study was planned to determine the effect of therapeutic play on nursing
        interventions and fear of medical materials in preschool children.
  
        Method/ Data Collection Techniques:This research was planned as a quasi-experimental study
        with pretest-posttest and control group. The universe of the research will consist of 170
        children studying in pre-school classes at the Chamber of Commerce Primary School located in
        the city center of Aydın. The sample size of the study was calculated using G*power analysis
        and it was found that a total of 70 children (study: 35 children, control: 35 children).
        However, considering the losses from the research and the possibility of children filling in
        the questionnaires incomplete or incorrectly, the number of children was increased by 10% and
        it was planned to complete the study with 80 (study: 40 children, control: 40 children)
        children. It is planned to collect the data between March 1 and June 1, 2023. The child to be
        included in the study and their parents will be informed about the study, verbal consent will
        be obtained from the children and written consent will be obtained from the parents. After
        obtaining parental consent about the study, the parents of the children in both the study and
        control groups will have to fill in the "Introductory Information Form" and the children will
        fill in the "Scale of Fear of Nursing Interventions and Used Materials in Children" before
        the therapeutic play. The therapeutic game content to be applied to the study group consists
        of four sessions organized by considering nursing interventions and materials used in the
        hospital. In each session, various game activities will be held with different materials.
        Therapeutic play activity will not be planned for the children in the control group. One week
        after the therapeutic play activities are completed, the children will have to fill out the
        "Scale of Fear Against Nursing Interventions and Used Materials in Children".
  
        The data obtained in the research will be analyzed using the SPSS (Statistical Package for
        Social Sciences) for Windows 22.0 program. Homogeneity of descriptive features between groups
        will be tested by chi-square analysis. The Kolmogorov Smirnov Test will be used to determine
        whether the research data are normally distributed. In the analysis of study data,
        descriptive statistics, if the data show normal distribution, independent group-t-test and
        changes within the group repeated measurements Anova test; If it does not have a normal
        distribution, Mann Whitney-U test and Wilcoxon signed-rank test will be used.
  
        Expected Results: Thanks to the results obtained from this study, it is expected that the
        familiarity of children with nursing interventions and materials with the therapeutic play
        method in their own environment such as school will help them experience less fear and adapt
        easily during a possible hospital experience in the future.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Health Services Research
  masking: Single (Participant)
  measure: Nursing interventions and fear of materials used in children scale
  time frame: baseline and week 4
  description: I am not afraid (1) I am extremely afraid (5). As the score increases, fear increases.
  arm group label: Therapeutic game to reduce fear of hospital and ambulance
  arm group type: Experimental
  description: therapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks.
  arm group label: Therapeutic game to reduce fear of injectors and eye drops
  arm group type: Experimental
  description: therapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks.
  arm group label: Therapeutic play to reduce fear of intrauterine and serum
  arm group type: Experimental
  description: therapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks.
  arm group label: Therapeutic play to reduce fear of EKG and EMG
  arm group type: Experimental
  description: therapeutic play was applied to 5 groups every day of the week and was completed in 4 weeks.
  intervention type: Other
  intervention name: Therapeutic play hospital fear and nursing interventions
  description: Children assigned to the study group will be divided into 5 groups, with a maximum of 8 children. The researcher will perform a therapeutic play activity with each group consisting of maximum 8 children one day of the week in the room and time determined by the school. Each activity will last an average of 30 minutes. Therapeutic play activities will be completed in 4 weeks.
  Therapeutic play activities will not be performed with the children in the control group.
  One week after the completion of the therapeutic play intervention, the researcher will re-fill the Child Nursing Interventions and Fear of Materials Scale-uncommon materials sub-dimension face-to-face with the children in the study and control groups.
  arm group label: Therapeutic game to reduce fear of hospital and ambulance
  arm group label: Therapeutic game to reduce fear of injectors and eye drops
  arm group label: Therapeutic play to reduce fear of EKG and EMG
  arm group label: Therapeutic play to reduce fear of intrauterine and serum
  criteria: 
  gender: All
  minimum age: 60 Months
  maximum age: 71 Months
  healthy volunteers: Accepts Healthy Volunteers
  last name: Filiz KARACA DEVELİ
  role: Principal Investigator
  affiliation: Aydin Adnan Menderes University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Aydin Adnan Menderes University
  investigator full name: Filiz KARACA DEVELİ
  investigator title: Principal Investigator
  sharing ipd: No