<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/NCT03838172</url>
  </required_header>
  <id_info>
    <org_study_id>GO 19/28</org_study_id>
    <nct_id>NCT03838172</nct_id>
  </id_info>
  <brief_title>Investigation of the Impact of Burn Injury on Parents</brief_title>
  <official_title>The Effects of Burn Injury on Parents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe 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>
      Burn injuries are related to longer hospital stay. Patients who have a burned child are&#xD;
      affected prolonged hospitalization. Social life and quality of life are affected by burn&#xD;
      injuries. Therefore, the aim of this study is to investigate the effects of burn injury on&#xD;
      parents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pediatric burn injuries is commonly seen. Burn injuries are extended from minor injuries to&#xD;
      severe injuries. The severity of burn injury may affect burn related complications such as&#xD;
      scar tissue and duration of hospitalization. This process extremely affect parents. Although&#xD;
      parents are part of this prolonged treatments process, there is no study that evaluated of&#xD;
      the impact of burn injury on parents. Therefore, the aim of this study is to investigate the&#xD;
      effects of burn injury on parents.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2019</start_date>
  <completion_date type="Actual">May 1, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Family of Impact scale</measure>
    <time_frame>15 minutes</time_frame>
    <description>questionnaire is a self-report instrument designed to measure the effects of childhood diseased on parents. A low score indicates a higher impact of the disease on the parents.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Nottingham Health Profile</measure>
    <time_frame>15 minutes</time_frame>
    <description>Nottingham Health Profile is a widely used measure of perceived health status. The higher score is indicated the lower quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The hospital anxiety and depression scale</measure>
    <time_frame>15 minutes</time_frame>
    <description>It is a self-reported questionnaire that measures level of anxiety and depression. the higher score is indicated the higher anxiety level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Spielberger State-Trait Anxiety Inventory</measure>
    <time_frame>15 minutes</time_frame>
    <description>It is used to determine anxiety level of parents. Higher scores are an indication of greater anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient and Observer Scar Assessment Scale</measure>
    <time_frame>15 minutes</time_frame>
    <description>The Patient and Observer Scar Assessment Scale consists of two scales, the patient scale, which contains six items, and the observer scale, which contains five items. The higher score indicates the greater scar tissue</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">32</enrollment>
  <condition>Burns</condition>
  <condition>Parents</condition>
  <arm_group>
    <arm_group_label>Parents</arm_group_label>
    <description>Parents who have a burned child</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Family impact scale</intervention_name>
    <description>The family Impact Scale (FIS) will be completed by the parents</description>
    <arm_group_label>Parents</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Parents who have a burned child&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents who have a burned child&#xD;
&#xD;
          -  Parents who have a volunteer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parents who have no confirm to participate this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ozden Ozkal</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>February 10, 2019</study_first_submitted>
  <study_first_submitted_qc>February 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>August 24, 2021</last_update_submitted>
  <last_update_submitted_qc>August 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Ozden Ozkal</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Burn Injury</keyword>
  <keyword>quality of life</keyword>
  <keyword>scar</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03838172
org study id: GO 19/28
nct id: NCT03838172
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Burn injuries are related to longer hospital stay. Patients who have a burned child are
      affected prolonged hospitalization. Social life and quality of life are affected by burn
      injuries. Therefore, the aim of this study is to investigate the effects of burn injury on
      parents.
Pediatric burn injuries is commonly seen. Burn injuries are extended from minor injuries to
      severe injuries. The severity of burn injury may affect burn related complications such as
      scar tissue and duration of hospitalization. This process extremely affect parents. Although
      parents are part of this prolonged treatments process, there is no study that evaluated of
      the impact of burn injury on parents. Therefore, the aim of this study is to investigate the
      effects of burn injury on parents.
observational model: Cohort
time perspective: Prospective
measure: Family of Impact scale
time frame: 15 minutes
description: questionnaire is a self-report instrument designed to measure the effects of childhood diseased on parents. A low score indicates a higher impact of the disease on the parents.
measure: Nottingham Health Profile
time frame: 15 minutes
description: Nottingham Health Profile is a widely used measure of perceived health status. The higher score is indicated the lower quality of life.
measure: The hospital anxiety and depression scale
time frame: 15 minutes
description: It is a self-reported questionnaire that measures level of anxiety and depression. the higher score is indicated the higher anxiety level.
measure: The Spielberger State-Trait Anxiety Inventory
time frame: 15 minutes
description: It is used to determine anxiety level of parents. Higher scores are an indication of greater anxiety.
measure: Patient and Observer Scar Assessment Scale
time frame: 15 minutes
description: The Patient and Observer Scar Assessment Scale consists of two scales, the patient scale, which contains six items, and the observer scale, which contains five items. The higher score indicates the greater scar tissue
arm group label: Parents
description: Parents who have a burned child
intervention type: Other
intervention name: Family impact scale
description: The family Impact Scale (FIS) will be completed by the parents
arm group label: Parents
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Ozden Ozkal
investigator title: Principal Investigator
mesh term: Burns
sharing ipd: No