Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06042075
Other study ID # 2023-0-100
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2023
Est. completion date June 2024

Study information

Verified date September 2023
Source University Hospital, Angers
Contact Ludovic Martin, MD PhD
Phone 02.41.35.34.19
Email LuMartin@chu-angers.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 140
Est. completion date June 2024
Est. primary completion date November 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire on congenital birthmarks
Questions will be put to health professionals on representation using a semi-quantitative questionnaire.

Locations

Country Name City State
France Department of Dermatology, University Hospital of Angers Angers Pays De Loire

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of the ways in which health professionals from Angers Maternity Unit represent congenital birthmarks found in newborns Representation by health professionals will be assessed using a semi-quantitative questionnaire 45 days
Secondary Assessment of the proportion of health professionals wishing to improve their knowledge of congenital birthmarks The question will be put to health professionals using a questionnaire 45 days
See also
  Status Clinical Trial Phase
Completed NCT05219136 - Improve the Comfort, Safety and Quality of Upper Endoscopy by a Modified Fasting Protocol N/A
Completed NCT03643003 - Music Therapy for Persons With Dementia N/A
Completed NCT03132909 - Attitudes and Feelings of Doctors Caring for Their Colleagues: a Qualitative Study in Picardy
Completed NCT05841602 - Quality of Nursing Care During The Covid-19 Pandemic