- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06042075
Representation of Congenital Birthmarks (ReCONNAISSANCE)
Representation of Congenital Birthmarks in Newborns by Angers Maternity Unit Health Professionals
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ludovic Martin, MD PhD
- Phone Number: +33 02.41.35.34.19
- Email: LuMartin@chu-angers.fr
Study Contact Backup
- Name: Béatrice Gable
- Phone Number: +33 02.41.35.68.25
- Email: begable@chu-angers.fr
Study Locations
-
-
Pays De Loire
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Angers, Pays De Loire, France, 49933
- Department of Dermatology, University Hospital of Angers
-
Contact:
- Ludovic Martin, MD, PhD
- Phone Number: +33 02.41.35.34.19
- Email: LuMartin@chu-angers.fr
-
Sub-Investigator:
- BERTHELOT Brieuc, Resident
-
Sub-Investigator:
- PREMEL Juliette, Resident
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria
All health professionnals working at Angers Maternity Unit:
- Midwives
- Nursing auxiliaries
- Childcare assistants
- Gynecologists
- Residents
- Pediatricians
Exclusion Criteria:
- Refusal to participate
- Non-health professionals working at Angers Maternity Unit (hospital cleaners, hospital food workers)
- Students (trainee pediatricians, trainee gynecologists, trainee midwives)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Health professionals
Health professionals working at Angers Maternity Unit include gynecologists, pediatricians, residents (gynecology and pediatric residents), childcare assistants, nursing auxiliaries and midwives.
|
Questions will be put to health professionals on representation using a semi-quantitative questionnaire.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the ways in which health professionals from Angers Maternity Unit represent congenital birthmarks found in newborns
Time Frame: 45 days
|
Representation by health professionals will be assessed using a semi-quantitative questionnaire
|
45 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the proportion of health professionals wishing to improve their knowledge of congenital birthmarks
Time Frame: 45 days
|
The question will be put to health professionals using a questionnaire
|
45 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-0-100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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