Body RepresentationReCONNAISSANCENCT06042075
Representation of Congenital Birthmarks
An observational study of Body Representation and Congenital Skin Disorder, run by University Hospital, Angers at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Body Representation, Congenital Skin Disorder, Feelings
- What is being tested?
- Questionnaire on congenital birthmarks
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2023to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All health professionnals working at Angers Maternity Unit: midwives, nursing auxiliaries, childcare assistants, gynecologists, residents, pediatricians
Who may be able to join
- All health professionnals working at Angers Maternity Unit:
- Midwives
- Nursing auxiliaries
- Childcare assistants
- Gynecologists
- Residents
- Pediatricians
Who cannot join
- Refusal to participate
- Non-health professionals working at Angers Maternity Unit (hospital cleaners, hospital food workers)
- Students (trainee pediatricians, trainee gynecologists, trainee midwives)
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Dermatology, University Hospital of Angers
Angers, Pays de Loire, 49933
Ludovic Martin, MD, PhD, 02.41.35.34.19 ext. +33, LuMartin@chu-angers.fr
BERTHELOT Brieuc, Resident
About this study
Official title: 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.
Read more
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
- Conditions
- Body Representation, Congenital Skin Disorder, Feelings
- Being tested
- Questionnaire on congenital birthmarks
- Keywords
- Newborns, Health Professionals, Maternity Unit, Congenital Birthmarks
- Medical subject headings
- Skin Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire on congenital birthmarksOther
Questions will be put to health professionals on representation using a semi-quantitative questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Health professionals | Health professionals working at Angers Maternity Unit include gynecologists, pediatricians, residents (gynecology and pediatric residents), childcare assistants, nursing auxiliaries and midwives. Receives: Other: Questionnaire on congenital birthmarks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study startOct 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Body RepresentationStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042075
- Sponsor's protocol ID
- 2023-0-100
- Acronym
- ReCONNAISSANCE
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 34828770Vivar 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Representation of Congenital Birthmarks in Newborns by Angers Maternity Unit Health Professionals
- ClinicalTrials.gov ID
- NCT06042075
- Acronym / sponsor ID
- ReCONNAISSANCE / 2023-0-100
- Conditions
- Body Representation, Congenital Skin Disorder, Feelings
- Keywords
- Newborns, Health Professionals, Maternity Unit, Congenital Birthmarks
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Oct 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health professionals | – | Other: Questionnaire on congenital birthmarksHealth professionals working at Angers Maternity Unit include gynecologists, pediatricians, residents (gynecology and pediatric residents), childcare assistants, nursing auxiliaries and midwives. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All health professionnals working at Angers Maternity Unit: midwives, nursing auxiliaries, childcare assistants, gynecologists, residents, pediatricians
Key inclusion criteria (7 listed)
- Midwives
- Nursing auxiliaries
- Childcare assistants
- Gynecologists
- Residents
Key exclusion criteria (3 listed)
- Refusal to participate
- Non-health professionals working at Angers Maternity Unit (hospital cleaners, hospital food workers)
- Students (trainee pediatricians, trainee gynecologists, trainee midwives)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire on congenital birthmarksQuestions will be put to health professionals on representation using a semi-quantitative questionnaire. | Other | Health professionals |
Primary outcome
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
1 secondary outcome
Assessment of the proportion of health professionals wishing to improve their knowledge of congenital birthmarks
Time frame: 45 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Background: PubMed 34828770Kelly 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.
- Background: PubMed 29872673Vivar 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.
- Effects on Quality of Life, Stigmatization, Bullying, and Suicide Risk in Pediatric Acne, Atopic Dermatitis, and Psoriasis PatientsLink provided by the sponsor.
- The impact of pediatric skin disease on self-esteemLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Representation and Congenital Skin Disorder, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ludovic Martin, MD PhD (02.41.35.34.19 ext. +33, LuMartin@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the ways in which health professionals from Angers Maternity Unit represent congenital birthmarks found in newborns (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06042075, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.