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/NCT06042075</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0-100</org_study_id>
      <nct_id>NCT06042075</nct_id>
    </id_info>
    <brief_title>Representation of Congenital Birthmarks</brief_title>
    <acronym>ReCONNAISSANCE</acronym>
    <official_title>Representation of Congenital Birthmarks in Newborns by Angers Maternity Unit Health Professionals</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Angers</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Angers</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>
        This descriptive cross-sectional single center study will be conducted at Angers Maternity&#xD;
        Unit.&#xD;
  &#xD;
        It pertains to the ways in which healthcare professionals represent congenital birthmarks&#xD;
        found in newborns.&#xD;
  &#xD;
        It is our assumption that health professionals may have a tendency to engage in inappropriate&#xD;
        behavior when dealing with congenital birthmarks due to lack of knowledge. We make the&#xD;
        presumption that insufficient knowledge causes difficulties in managing these birthmarks.&#xD;
  &#xD;
        Data as to representation of birthmarks in newborns by health professionals will be collected&#xD;
        using a semi-quantitative questionnaire.&#xD;
  &#xD;
        This study constitutes preliminary research work, with a view to creating a professional&#xD;
        development plan if necessary.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This descriptive cross-sectional observational study will take place at a single center:&#xD;
        Angers Hospital Maternity Unit.&#xD;
  &#xD;
        Our aim is to assess how healthcare professionals represent congenital birthmarks in newborn&#xD;
        infants.&#xD;
  &#xD;
        We intend to use an optional anonymous questionnaire that will be placed strategically in&#xD;
        Angers Maternity Unit workspaces . Each health professional from Angers Maternity Unit will&#xD;
        be asked to complete this questionnaire.&#xD;
  &#xD;
        In this five-minute questionnaire, they will be asked questions regarding their&#xD;
        representation of congenital birthmarks, their feelings and their knowledge.&#xD;
  &#xD;
        We make the hypothesis that some health professionals lack knowledge and are uncomfortable&#xD;
        with managing these birthmarks and providing explanations to the parents of newborn infants.&#xD;
        We also show them some examples of birthmarks, prompting them to express any feelings they&#xD;
        may have.&#xD;
  &#xD;
        This questionnaire was co-written by Pauline VABRES, a psychologist with experience in the&#xD;
        field of self-representation.&#xD;
  &#xD;
        The questionnaire will remain accessible for 45 days, ensuring that every Maternity Unit&#xD;
        health professional has the opportunity to participate (approximately 140 people, excluding&#xD;
        non-health professionals working in the Maternity Unit and students).&#xD;
  &#xD;
        On completion of the questionnaire, the healthcare professionals will seal their answers in&#xD;
        envelopes to guarantee anonymity.&#xD;
  &#xD;
        At the end of the 45-day period, the answers will be collected and analyzed.&#xD;
  &#xD;
        If required, the second phase of this work will focus on developing educational interventions&#xD;
        for health professionals to enhance their knowledge of congenital birthmarks. We also hope to&#xD;
        improve management of these lesions and enhance the quality of the explanations provided to&#xD;
        parents of newborns.&#xD;
  &#xD;
        Previous studies have already addressed the feelings of parents confronted with congenital&#xD;
        birthmarks. To our knowledge, this is the first study of its kind to evaluate the perspective&#xD;
        of health professionals&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">November 2023</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>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Assessment of the ways in which health professionals from Angers Maternity Unit represent congenital birthmarks found in newborns</measure>
      <time_frame>45 days</time_frame>
      <description>Representation by health professionals will be assessed using a semi-quantitative questionnaire</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assessment of the proportion of health professionals wishing to improve their knowledge of congenital birthmarks</measure>
      <time_frame>45 days</time_frame>
      <description>The question will be put to health professionals using a questionnaire</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">140</enrollment>
    <condition>Body Representation</condition>
    <condition>Congenital Skin Disorder</condition>
    <condition>Feelings</condition>
    <arm_group>
      <arm_group_label>Health professionals</arm_group_label>
      <description>Health professionals working at Angers Maternity Unit include gynecologists, pediatricians, residents (gynecology and pediatric residents), childcare assistants, nursing auxiliaries and midwives.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire on congenital birthmarks</intervention_name>
      <description>Questions will be put to health professionals on representation using a semi-quantitative questionnaire.</description>
      <arm_group_label>Health professionals</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All health professionnals working at Angers Maternity Unit: midwives, nursing auxiliaries,&#xD;
          childcare assistants, gynecologists, residents, pediatricians&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria&#xD;
  &#xD;
          All health professionnals working at Angers Maternity Unit:&#xD;
  &#xD;
            -  Midwives&#xD;
  &#xD;
            -  Nursing auxiliaries&#xD;
  &#xD;
            -  Childcare assistants&#xD;
  &#xD;
            -  Gynecologists&#xD;
  &#xD;
            -  Residents&#xD;
  &#xD;
            -  Pediatricians&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal to participate&#xD;
  &#xD;
            -  Non-health professionals working at Angers Maternity Unit (hospital cleaners, hospital&#xD;
               food workers)&#xD;
  &#xD;
            -  Students (trainee pediatricians, trainee gynecologists, trainee midwives)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ludovic Martin, MD PhD</last_name>
      <phone>02.41.35.34.19</phone>
      <phone_ext>+33</phone_ext>
      <email>LuMartin@chu-angers.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Béatrice Gable</last_name>
      <phone>02.41.35.68.25</phone>
      <phone_ext>+33</phone_ext>
      <email>begable@chu-angers.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of Dermatology, University Hospital of Angers</name>
        <address>
          <city>Angers</city>
          <state>Pays De Loire</state>
          <zip>49933</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Ludovic Martin, MD, PhD</last_name>
        <phone>02.41.35.34.19</phone>
        <phone_ext>+33</phone_ext>
        <email>LuMartin@chu-angers.fr</email>
      </contact>
      <investigator>
        <last_name>BERTHELOT Brieuc, Resident</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>PREMEL Juliette, Resident</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/29872673/</url>
      <description>Effects on Quality of Life, Stigmatization, Bullying, and Suicide Risk in Pediatric Acne, Atopic Dermatitis, and Psoriasis Patients</description>
    </link>
    <link>
      <url>https://pubmed.ncbi.nlm.nih.gov/34828770/</url>
      <description>The impact of pediatric skin disease on self-esteem</description>
    </link>
    <reference>
      <citation>Kelly KA, Balogh EA, Kaplan SG, Feldman SR. Skin Disease in Children: Effects on Quality of Life, Stigmatization, Bullying, and Suicide Risk in Pediatric Acne, Atopic Dermatitis, and Psoriasis Patients. Children (Basel). 2021 Nov 16;8(11):1057. doi: 10.3390/children8111057.</citation>
      <PMID>34828770</PMID>
    </reference>
    <reference>
      <citation>Vivar KL, Kruse L. The impact of pediatric skin disease on self-esteem. Int J Womens Dermatol. 2017 Dec 12;4(1):27-31. doi: 10.1016/j.ijwd.2017.11.002. eCollection 2018 Mar.</citation>
      <PMID>29872673</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Newborns</keyword>
    <keyword>Health Professionals</keyword>
    <keyword>Maternity Unit</keyword>
    <keyword>Congenital Birthmarks</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Skin Abnormalities</mesh_term>
      <mesh_term>Skin Diseases</mesh_term>
    </condition_browse>
    <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/NCT06042075
  org study id: 2023-0-100
  nct id: NCT06042075
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This descriptive cross-sectional single center study will be conducted at Angers Maternity
        Unit.
  
        It pertains to the ways in which healthcare professionals represent congenital birthmarks
        found in newborns.
  
        It is our assumption that health professionals may have a tendency to engage in inappropriate
        behavior when dealing with congenital birthmarks due to lack of knowledge. We make the
        presumption that insufficient knowledge causes difficulties in managing these birthmarks.
  
        Data as to representation of birthmarks in newborns by health professionals will be collected
        using a semi-quantitative questionnaire.
  
        This study constitutes preliminary research work, with a view to creating a professional
        development plan if necessary.
  This descriptive cross-sectional observational study will take place at a single center:
        Angers Hospital Maternity Unit.
  
        Our aim is to assess how healthcare professionals represent congenital birthmarks in newborn
        infants.
  
        We intend to use an optional anonymous questionnaire that will be placed strategically in
        Angers Maternity Unit workspaces . Each health professional from Angers Maternity Unit will
        be asked to complete this questionnaire.
  
        In this five-minute questionnaire, they will be asked questions regarding their
        representation of congenital birthmarks, their feelings and their knowledge.
  
        We make the hypothesis that some health professionals lack knowledge and are uncomfortable
        with managing these birthmarks and providing explanations to the parents of newborn infants.
        We also show them some examples of birthmarks, prompting them to express any feelings they
        may have.
  
        This questionnaire was co-written by Pauline VABRES, a psychologist with experience in the
        field of self-representation.
  
        The questionnaire will remain accessible for 45 days, ensuring that every Maternity Unit
        health professional has the opportunity to participate (approximately 140 people, excluding
        non-health professionals working in the Maternity Unit and students).
  
        On completion of the questionnaire, the healthcare professionals will seal their answers in
        envelopes to guarantee anonymity.
  
        At the end of the 45-day period, the answers will be collected and analyzed.
  
        If required, the second phase of this work will focus on developing educational interventions
        for health professionals to enhance their knowledge of congenital birthmarks. We also hope to
        improve management of these lesions and enhance the quality of the explanations provided to
        parents of newborns.
  
        Previous studies have already addressed the feelings of parents confronted with congenital
        birthmarks. To our knowledge, this is the first study of its kind to evaluate the perspective
        of health professionals
  observational model: Other
  time perspective: Cross-Sectional
  measure: Assessment of the ways in which health professionals from Angers Maternity Unit represent congenital birthmarks found in newborns
  time frame: 45 days
  description: Representation by health professionals will be assessed using a semi-quantitative questionnaire
  measure: Assessment of the proportion of health professionals wishing to improve their knowledge of congenital birthmarks
  time frame: 45 days
  description: The question will be put to health professionals using a questionnaire
  arm group label: Health professionals
  description: Health professionals working at Angers Maternity Unit include gynecologists, pediatricians, residents (gynecology and pediatric residents), childcare assistants, nursing auxiliaries and midwives.
  intervention type: Other
  intervention name: Questionnaire on congenital birthmarks
  description: Questions will be put to health professionals on representation using a semi-quantitative questionnaire.
  arm group label: Health professionals
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Ludovic Martin, MD PhD
  phone: 02.41.35.34.19
  phone ext: +33
  email: LuMartin@chu-angers.fr
  last name: Béatrice Gable
  phone: 02.41.35.68.25
  phone ext: +33
  email: begable@chu-angers.fr
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: France
  url: https://pubmed.ncbi.nlm.nih.gov/29872673/
  description: Effects on Quality of Life, Stigmatization, Bullying, and Suicide Risk in Pediatric Acne, Atopic Dermatitis, and Psoriasis Patients
  url: https://pubmed.ncbi.nlm.nih.gov/34828770/
  description: The impact of pediatric skin disease on self-esteem
  citation: Kelly KA, Balogh EA, Kaplan SG, Feldman SR. Skin Disease in Children: Effects on Quality of Life, Stigmatization, Bullying, and Suicide Risk in Pediatric Acne, Atopic Dermatitis, and Psoriasis Patients. Children (Basel). 2021 Nov 16;8(11):1057. doi: 10.3390/children8111057.
  PMID: 34828770
  citation: Vivar KL, Kruse L. The impact of pediatric skin disease on self-esteem. Int J Womens Dermatol. 2017 Dec 12;4(1):27-31. doi: 10.1016/j.ijwd.2017.11.002. eCollection 2018 Mar.
  PMID: 29872673
  responsible party type: Sponsor
  mesh term: Skin Abnormalities
  mesh term: Skin Diseases
  sharing ipd: No