<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/NCT03828552</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL18_0700</org_study_id>
    <nct_id>NCT03828552</nct_id>
  </id_info>
  <brief_title>Parents' Experience of Their Children Stay in a Pediatric Intensive Care Unit.</brief_title>
  <acronym>VECUREA</acronym>
  <official_title>Parents' Experience of Their Children Stay in a Pediatric Intensive Care Unit.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      Children recovered in pediatric intensive care unit (PICU) suffer from severe conditions,&#xD;
      sometimes life-threatening. Thus, priority is given to urgent somatic care, children&#xD;
      medicalization is strong, invasive technics have to be used, and medical monitoring is close.&#xD;
&#xD;
      A stay in PICU often leaves a painful memory to the child and family, and can lead to&#xD;
      psychological morbidity such as post-traumatic stress disease.&#xD;
&#xD;
      This study aims to assess parents' experience during their child hospitalization in PICU, and&#xD;
      the impact of this stay on the entire family in the following month.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 4, 2019</start_date>
  <completion_date type="Actual">June 21, 2019</completion_date>
  <primary_completion_date type="Actual">June 21, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Analyse qualitatively the parents'experience during the PICU stay of their child</measure>
    <time_frame>1 month</time_frame>
    <description>Analysis of french written answers on a feedback form of about 10 pages (free written answers or Likert scale)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the impact on the family of this PICU stay of their child</measure>
    <time_frame>1 month</time_frame>
    <description>Analysis of french written answers on a feedback form of about 10 pages (free written answers or Likert scale)</description>
  </primary_outcome>
  <enrollment type="Actual">47</enrollment>
  <condition>Intensive Care Unit Syndrome</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Parents will be recruited in a Pediatric Resuscitation Department of the Mother and Child Hospital for 3 months. The doctor taking care of a child and his parents meeting the eligibility criteria will distribute, during the stay, a questionnaire accompanied by a pre-stamped envelope to the two parents not opposing the study.&#xD;
A phone call and / or an email reminder by the intern in the month of the exit will invite each parent to return the questionnaire.&#xD;
The completed questionnaire will be mailed back by the parents using the pre-stamped envelope.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Parent (mother or /and father) of a recovered child in the PICU for at least 3 days, for a&#xD;
        first stay, without limit of age, disease or admission mode.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parent (mother or /and father) of a recovered child in PICU.&#xD;
&#xD;
          -  No limit of age, disease or admission mode.&#xD;
&#xD;
          -  First stay in PICU, for at least a 3 days stay.&#xD;
&#xD;
          -  Parents having been informed and having accepted the participation in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Death of the child during the stay in PICU or during the month following the discharge&#xD;
             from PICU&#xD;
&#xD;
          -  Non-fluent french speakers/readers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pediatric intensive care unit of Women-Mother-Children Hospital</name>
      <address>
        <city>Bron</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>September 4, 2019</last_update_submitted>
  <last_update_submitted_qc>September 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03828552
org study id: 69HCL18_0700
nct id: NCT03828552
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Children recovered in pediatric intensive care unit (PICU) suffer from severe conditions,
      sometimes life-threatening. Thus, priority is given to urgent somatic care, children
      medicalization is strong, invasive technics have to be used, and medical monitoring is close.

      A stay in PICU often leaves a painful memory to the child and family, and can lead to
      psychological morbidity such as post-traumatic stress disease.

      This study aims to assess parents' experience during their child hospitalization in PICU, and
      the impact of this stay on the entire family in the following month.
observational model: Other
time perspective: Prospective
measure: Analyse qualitatively the parents'experience during the PICU stay of their child
time frame: 1 month
description: Analysis of french written answers on a feedback form of about 10 pages (free written answers or Likert scale)
measure: Assessment of the impact on the family of this PICU stay of their child
time frame: 1 month
description: Analysis of french written answers on a feedback form of about 10 pages (free written answers or Likert scale)
intervention type: Other
intervention name: Questionnaire
description: Parents will be recruited in a Pediatric Resuscitation Department of the Mother and Child Hospital for 3 months. The doctor taking care of a child and his parents meeting the eligibility criteria will distribute, during the stay, a questionnaire accompanied by a pre-stamped envelope to the two parents not opposing the study.
A phone call and / or an email reminder by the intern in the month of the exit will invite each parent to return the questionnaire.
The completed questionnaire will be mailed back by the parents using the pre-stamped envelope.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No