<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/NCT04453410</url>
  </required_header>
  <id_info>
    <org_study_id>7732</org_study_id>
    <nct_id>NCT04453410</nct_id>
  </id_info>
  <brief_title>Validation of a Pediatric Pictorial Version of the QOR-15 Postoperatory Functional Recovery Scale - QoR-15 Pédiatric</brief_title>
  <official_title>Validation of a Pediatric Pictorial Version of the QOR-15 Postoperatory Functional Recovery Scale - QoR-15 Pédiatric</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</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>
      Consideration from the patient's point of view is an important step in improving&#xD;
      postoperative functional recovery. The questionnaire Quality-of-recovery 15 (QoR-15) is a&#xD;
      psychometrically validated questionnaire to measure the quality of postoperative functional&#xD;
      recovery. it has been recommended in perioperative medecine however, this questionnaire was&#xD;
      never adapted and validated for a pediatric surgical population.&#xD;
&#xD;
      The main objective of this protocol is to study the validity, reliability, acceptability and&#xD;
      feasibility in routine clinical practice of a pediatric pictorial version of the QoR-15&#xD;
      score.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 29, 2020</start_date>
  <completion_date type="Actual">December 14, 2021</completion_date>
  <primary_completion_date type="Actual">September 29, 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>Questionnaire Quality-of-recovery 15 score</measure>
    <time_frame>3 months</time_frame>
    <description>functional recovery score Questionnaire Quality-of-recovery 15 in pictorial version established at J1 postoperatively.</description>
  </primary_outcome>
  <enrollment type="Actual">153</enrollment>
  <condition>Surgical Intervention</condition>
  <condition>Minor</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Quality-of-recovery 15 (QoR-15)</intervention_name>
    <description>Children will use the questionnaire Quality-of-recovery 15 (QoR-15)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Minor patient over 7 years and up to 17 years and 9 months who have a programming surgery&#xD;
        as part of routine management&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient underage over 7 years and up to 17 years and 9 months&#xD;
&#xD;
          -  Programming surgery as part of routine management&#xD;
&#xD;
          -  Patient affiliated with a health insurance social&#xD;
&#xD;
          -  Parental authority holders and the patient agreeing to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe sensory impairment in preoperation preventing reliable&#xD;
             participation in the questionnaire&#xD;
&#xD;
          -  Patients at risk of severe cognitive or sensory impairment in postoperative&#xD;
&#xD;
          -  Patients with language difficulties in the language of administration of the&#xD;
             questionnaire&#xD;
&#xD;
          -  Patients who can not express their non-opposition to participation in the study&#xD;
&#xD;
          -  Refusal of holders of parental authority and/or refusal of the patient to participate&#xD;
             in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Les Hôpitaux Universitaires de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>August 21, 2023</last_update_submitted>
  <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>questionnaire Quality-of-recovery 15 (QoR-15)</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04453410
org study id: 7732
nct id: NCT04453410
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Consideration from the patient's point of view is an important step in improving
      postoperative functional recovery. The questionnaire Quality-of-recovery 15 (QoR-15) is a
      psychometrically validated questionnaire to measure the quality of postoperative functional
      recovery. it has been recommended in perioperative medecine however, this questionnaire was
      never adapted and validated for a pediatric surgical population.

      The main objective of this protocol is to study the validity, reliability, acceptability and
      feasibility in routine clinical practice of a pediatric pictorial version of the QoR-15
      score.
observational model: Cohort
time perspective: Prospective
measure: Questionnaire Quality-of-recovery 15 score
time frame: 3 months
description: functional recovery score Questionnaire Quality-of-recovery 15 in pictorial version established at J1 postoperatively.
intervention type: Other
intervention name: Questionnaire Quality-of-recovery 15 (QoR-15)
description: Children will use the questionnaire Quality-of-recovery 15 (QoR-15)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided