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/NCT06036940</url>
    </required_header>
    <id_info>
      <org_study_id>TYILDIZ</org_study_id>
      <nct_id>NCT06036940</nct_id>
    </id_info>
    <brief_title>Perioperative Anxiety in Children</brief_title>
    <official_title>COMPARISON OF 3 DIFFERENT METHODS FOR REDUCING THE LEVEL OF PERIOPERATIVE ANXIETY IN CHILDREN AGED 4-7: A RANDOMIZED CONTROLLED STUDY</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Namik Kemal University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Namik Kemal 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>
        The study was conducted to evaluate the effect of preoperative patient education given by&#xD;
        three different methods on the level of perioperative anxiety in children aged 4-7 years. The&#xD;
        research was carried out between 1 June - 31 November 2021 at Tekirdag Namık Kemal University&#xD;
        Health Practice and Research Center, Department of Pediatric Surgery. A total of 66 patients,&#xD;
        22 patients in each group, who met the inclusion criteria and were included in the stratified&#xD;
        randomization method, were included in the planned quasi-experimental study. Research data&#xD;
        were obtained by using the &quot;Patient Diagnosis Form&quot; and the &quot;Anxiety Scale in Preschool&#xD;
        Children&quot; administered before and after the surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pre-operative patient education was given to the children in the first experimental group by&#xD;
        the service nurse. The children in the second experimental group were given pre-operative&#xD;
        patient education by the service nurse, in addition, patient visits were provided by the&#xD;
        operating room nurse and the operating room environment was explained through play. The&#xD;
        children in the third experimental group were given pre-operative patient education by the&#xD;
        service nurse, after which they listened to the mother's voice recording and loving words&#xD;
        until they went to the operating room. It was determined that 69.7% of the mothers of the&#xD;
        children participating in the study were 30 years and older, 81.8% were married, 37.9% were&#xD;
        undergraduate graduates, and 51.5% were unemployed. The general anxiety disorder levels of&#xD;
        those who had no previous surgery experience were found significantly higher than those who&#xD;
        had previous surgery experience (p&lt;0.05). In terms of affecting the anxiety level, there was&#xD;
        a significant difference between the preoperative methods (p&lt;0.05). It was determined that&#xD;
        the education given by both the service nurse and the operating room nurse together was more&#xD;
        effective than other methods in reducing the anxiety levels of children, and there was a&#xD;
        statistically significant difference between them. (p&lt;0.05)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 1, 2021</start_date>
    <completion_date type="Actual">February 7, 2022</completion_date>
    <primary_completion_date type="Actual">November 30, 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>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient Diagnosis Form</measure>
      <time_frame>5 month</time_frame>
      <description>This section consists of a total of 11 questions prepared by the researcher in the light of the literature, including the introductory characteristics of patients and mothers, their previous surgical experience and their expectations from nurses.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anxiety Scale in Preschool Children</measure>
      <time_frame>5 month</time_frame>
      <description>Anxiety Scale for Preschool Children consists of a 5-point Likert scale. It is scored from 0 (not at all true), 1 (rarely true), 2 (sometimes true), 3 (quite true), 4 (very often true), from 0 to 4, and parents are expected to evaluate their children. The original scale measures 4 factors. These factors should consist of 4 sub-dimensions, social anxiety disorder, generalized anxiety disorder, separation anxiety disorder, and specific phobia. There are 29 items that are expected to be answered in total. Cronbach's Alpha values of the sub-dimensions range from .72 to .92.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">66</enrollment>
    <condition>Nurse's Role</condition>
    <arm_group>
      <arm_group_label>First Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The children in the first control group were given pre-operative patient education by the service nurse.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Second Experimental Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The children in the second experimental group were given pre-operative patient education by the service nurse, also patient visits were provided by the operating room nurse and the operating room environment was explained through play.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Third Experimental Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The children in the third experimental group were given pre-operative patient education by the service nurse, and then the mother's voice recording was played until they went to the operating room.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Preoperative patient education given with three different methods</intervention_name>
      <description>To determine the effect of preoperative patient education given by three different methods on the level of perioperative anxiety in children aged 4-7 years.</description>
      <arm_group_label>Second Experimental Group</arm_group_label>
      <arm_group_label>Third Experimental Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Planned elective surgery related to pediatric surgery,&#xD;
  &#xD;
            -  Having no problems in communicating,&#xD;
  &#xD;
            -  Volunteer to participate in the research&#xD;
  &#xD;
            -  Children aged 4-7 years&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children scheduled for emergency surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>7 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Tülin YILDIZ, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Namik Kemal University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Tekirdag Namık Kemal University</name>
        <address>
          <city>Tekirdag</city>
          <state>Suleymanpasa</state>
          <zip>59000</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 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>Namik Kemal University</investigator_affiliation>
      <investigator_full_name>Tülin YILDIZ</investigator_full_name>
      <investigator_title>Prof. Dr.</investigator_title>
    </responsible_party>
    <keyword>Anxiety</keyword>
    <keyword>child sick</keyword>
    <keyword>surgical nursing</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/NCT06036940
  org study id: TYILDIZ
  nct id: NCT06036940
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study was conducted to evaluate the effect of preoperative patient education given by
        three different methods on the level of perioperative anxiety in children aged 4-7 years. The
        research was carried out between 1 June - 31 November 2021 at Tekirdag Namık Kemal University
        Health Practice and Research Center, Department of Pediatric Surgery. A total of 66 patients,
        22 patients in each group, who met the inclusion criteria and were included in the stratified
        randomization method, were included in the planned quasi-experimental study. Research data
        were obtained by using the "Patient Diagnosis Form" and the "Anxiety Scale in Preschool
        Children" administered before and after the surgery.
  Pre-operative patient education was given to the children in the first experimental group by
        the service nurse. The children in the second experimental group were given pre-operative
        patient education by the service nurse, in addition, patient visits were provided by the
        operating room nurse and the operating room environment was explained through play. The
        children in the third experimental group were given pre-operative patient education by the
        service nurse, after which they listened to the mother's voice recording and loving words
        until they went to the operating room. It was determined that 69.7% of the mothers of the
        children participating in the study were 30 years and older, 81.8% were married, 37.9% were
        undergraduate graduates, and 51.5% were unemployed. The general anxiety disorder levels of
        those who had no previous surgery experience were found significantly higher than those who
        had previous surgery experience (p<0.05). In terms of affecting the anxiety level, there was
        a significant difference between the preoperative methods (p<0.05). It was determined that
        the education given by both the service nurse and the operating room nurse together was more
        effective than other methods in reducing the anxiety levels of children, and there was a
        statistically significant difference between them. (p<0.05)
  allocation: Randomized
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Patient Diagnosis Form
  time frame: 5 month
  description: This section consists of a total of 11 questions prepared by the researcher in the light of the literature, including the introductory characteristics of patients and mothers, their previous surgical experience and their expectations from nurses.
  measure: Anxiety Scale in Preschool Children
  time frame: 5 month
  description: Anxiety Scale for Preschool Children consists of a 5-point Likert scale. It is scored from 0 (not at all true), 1 (rarely true), 2 (sometimes true), 3 (quite true), 4 (very often true), from 0 to 4, and parents are expected to evaluate their children. The original scale measures 4 factors. These factors should consist of 4 sub-dimensions, social anxiety disorder, generalized anxiety disorder, separation anxiety disorder, and specific phobia. There are 29 items that are expected to be answered in total. Cronbach's Alpha values of the sub-dimensions range from .72 to .92.
  arm group label: First Control Group
  arm group type: No Intervention
  description: The children in the first control group were given pre-operative patient education by the service nurse.
  arm group label: Second Experimental Group
  arm group type: Experimental
  description: The children in the second experimental group were given pre-operative patient education by the service nurse, also patient visits were provided by the operating room nurse and the operating room environment was explained through play.
  arm group label: Third Experimental Group
  arm group type: Experimental
  description: The children in the third experimental group were given pre-operative patient education by the service nurse, and then the mother's voice recording was played until they went to the operating room.
  intervention type: Other
  intervention name: Preoperative patient education given with three different methods
  description: To determine the effect of preoperative patient education given by three different methods on the level of perioperative anxiety in children aged 4-7 years.
  arm group label: Second Experimental Group
  arm group label: Third Experimental Group
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 7 Years
  healthy volunteers: No
  last name: Tülin YILDIZ, Prof. Dr.
  role: Principal Investigator
  affiliation: Namik Kemal University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Namik Kemal University
  investigator full name: Tülin YILDIZ
  investigator title: Prof. Dr.
  sharing ipd: No