- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05284279
Early Childhood Caries and Health Professionals' Perception: a Qualitative Research Protocol to Assess Oral Health Stigma (CariStigma)
Dental caries is the most common non-communicable disease in childhood. Disease management of caries rests on surgical treatment as well as various preventive strategies such as fluoridation, sealants, personal counselling...
With other non-communicable diseases (obesity, overweight…), it has been demonstrated that health professionals' negative perceptions of their patients could affect disease management quality. Concerning dental caries, some data might suggest that discriminating believes and behaviours toward children with dental caries and their families exist in the medical setting. However, oral health related stigma remains an unexplored issue. This study would be the first to our knowledge to specifically address the question of stigmatisation and discrimination of patients with dental caries. The present project is to conduct an exploratory study focusing on perceptions and attitudes of health professionals toward children with early childhood caries and their parents.
The questions the study aims to answer are: (i) What are health professionals 'perceptions of children with ECC and their family? And (ii) according to health professionals, do these perceptions influence the quality of their care? We hypothesize that some practitioners have negative opinions on children with ECC and their parents, affecting the quality of their care, especially concerning oral health prevention.
Method: Individual semi-structured interviews will be conducted among dentists (general or pediatric), general practitioners and paediatricians.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Guillemette LIENHART, MD
- Phone Number: +33 06.20.66.37.37
- Email: Guillemette.lienhart@chu-lyon.fr
Study Contact Backup
- Name: Marc CHANELIERE
- Email: marc.chaneliere@univ-lyon1.fr
Study Locations
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Rhone-Alpes Region, France
- As much as possible, interviews will be performed face to face at a location convenient to the respondent or using videoconference due to COVID19 pandemic context.
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Contact:
- Guillemette LIENHART, MD
- Phone Number: +33 06.20.66.37.37
- Email: Guillemette.lienhart@chu-lyon.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- speak French fluently
- practice with children as a dentist (general or pediatric), a general practitioner, or a paediatrician
- work in hospital or ambulatory facility
Exclusion Criteria:
- NA
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Health professionals practicing with children
To participate, health professionals will have to speak French fluently, practice with children as a dentist (general or pediatric), a general practitioner, or a paediatrician and work in hospital or ambulatory facility. As paediatricians and general practitioners meet the child regularly during the first 6 years of life for medical follow-up, they are key stakeholders in the early detection of caries, referrals to dentist and counselling. The participants will be recruited using a semi-random sampling method. The sample will be constituted with a maximum variation in age, gender, years in practice, occupation and types of practice (solo, group or interdisciplinary team). |
Following a literature review on the topic of children with ECC and their family, a guidebook will be built by main investigators. Several test interviews will be conduct to ensure that guidebook is adapted, and that the interviewer is enough trained. Interview will be conducted by one or two of the main investigators. As much as possible, they will be performed face to face or using videoconference due to COVID19 pandemic context. All the interviews will be audio recorded. The interviewer will take notes including non-verbal communication; and will adopt an active listening position. After collecting respondents' characteristics (age, gender, profession, exercise duration, type of practice), the subsequent themes will be explored: disease perception, educational context's responsibility, barriers and facilitators to family behaviour changes, health professional's emotional consequences. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Health professionals' representations of children with dental caries and their family
Time Frame: The main outcome will be collected during the interviews.
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Individual semi-structured interviews will be conducted among dentists, general practitioners and paediatricians to explore health professionals' representations of children with dental caries and their family.
All the interviews will be audio recorded and transcribed into verbatims.
Verbatims will be analysed using the N'Vivo qualitative analysis software.
The thematic analysis of the data will then be carried out using the 6-steps method of Braun and Clarke.
A transversal analysis will be conducted by classifying the verbatims of each interview into themes and main theme.
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The main outcome will be collected during the interviews.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Keywords
Other Study ID Numbers
- 69HCL21_1182
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
product manufactured in and exported from the U.S.
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