ClinicalTrials.gg
Not yet recruitingNCT06042075ReCONNAISSANCEUpdated Sep 18, 2023

Representation of Congenital Birthmarks

An observational study in Body Representation, Congenital Skin Disorder and Feelings, sponsored by University Hospital, Angers. Not yet recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2023-09-18.

Sponsored by University Hospital, Angers · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2023, 3 years ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
140
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Body Representation
  • Congenital Skin Disorder
  • Feelings

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Keywords

  • Newborns
  • Health Professionals
  • Maternity Unit
  • Congenital Birthmarks
03

In context

Skin Abnormalities

39 studies on the registry are indexed under Skin Abnormalities; 7 are open to participants now.

This study's planned enrollment of 140 is close to the median of 140 across 11 observational studies indexed under Skin Abnormalities.

Browse Skin Abnormalities studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All health professionnals working at Angers Maternity Unit: midwives, nursing auxiliaries, childcare assistants, gynecologists, residents, pediatricians

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

All health professionnals working at Angers Maternity Unit:

  • Midwives
  • Nursing auxiliaries
  • Childcare assistants
  • Gynecologists
  • Residents
  • Pediatricians

Exclusion criteria

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)
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
140 participants (estimated)
Patient registry
No

Groups and cohorts

  • Health professionals

    Health professionals working at Angers Maternity Unit include gynecologists, pediatricians, residents (gynecology and pediatric residents), childcare assistants, nursing auxiliaries and midwives.

    Other: Questionnaire on congenital birthmarks

Interventions

  • OtherQuestionnaire on congenital birthmarks

    Questions will be put to health professionals on representation using a semi-quantitative questionnaire.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 45 days

Secondary outcomes

  1. 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

    Time frame: 45 days

07

Study locations

1 site
  • Department of Dermatology, University Hospital of Angers
    Angers, Pays De Loire 49933, France
    • Ludovic Martin, MD, PhD · ContactLuMartin@chu-angers.fr · 02.41.35.34.19
    • BERTHELOT Brieuc, Resident · Sub investigator
    • PREMEL Juliette, Resident · Sub investigator
08

References and documents

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. PubMed 34828770 ↗
  • 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. PubMed 29872673 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2023; primary completion for Nov 2023, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2023
First posted
Sep 18, 2023
StartEst.
Oct 2023
Primary completionEst.
Nov 2023
CompletionEst.
Jun 2024
Last update
Sep 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06042075
Responsible party
Sponsor
First posted
Sep 18, 2023
Start date
Oct 2023 (estimated)
Primary completion
Nov 2023 (estimated)
Completion
Jun 2024 (estimated)
Last update
Sep 18, 2023

Study contacts

Ludovic Martin, MD PhD
Contact
LuMartin@chu-angers.fr
02.41.35.34.19 ext. +33
Béatrice Gable
Contact
begable@chu-angers.fr
02.41.35.68.25 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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