Actively Recruiting
Music During Dental Children Care Under MEOPA
Led by Centre Hospitalier Universitaire de Nice · Updated on 2024-05-17
177
Participants Needed
4
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In France, the improvement of dental care for children in general and even more so for children with special needs is a real public health issue. Indeed, children under 6 years of age, children with a fear that is difficult to control and who have failed to receive care, or children with disabilities, have difficulties in receiving care. Because of their medical wandering before effective therapeutic care, they are up to 4 times more likely to have a very degraded oral health condition involving avulsions rather than conservative care. Moreover, these complex situations often lead to the indication of dental care under conscious sedation with an equimolar mixture of oxygen and nitrous oxide (MEOPA) or even under general anesthesia (GA); hospital sedation by administration of midazolam is exceptionally proposed. As access to GA care is largely insufficient, solutions likely to improve the success rate of care and anxiolysis provided by MEOPA associated with cognitive-behavioral management must be considered. Among these, music has been shown to have variable neurophysiological effects (action on cardiac and respiratory rhythms and on blood pressure), depending on the style of music used. During dental care, a biological and psychological impact on emotion has been highlighted, although the few studies carried out in children in this particular context are not at a high level of proof. In children with special needs, the addition of music to MEOPA could therefore increase relaxation or distraction during dental care and improve the success rate of sedation by MEOPA. Validation of this hypothesis would limit the redirection of the young patient under GA and prevent the loss of opportunity associated with a further delay in care of several months.
CONDITIONS
Official Title
Music During Dental Children Care Under MEOPA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 4 to 12 years referred for dental care under sedation in one of the four HU dental services
- Children requiring at least two sessions of the same type and duration
- Consent of the holders of parental authority, consent of the children
- Health coverage for the child (social security affiliation)
- Child and parents are French speaking and able to communicate with the medical team
You will not qualify if you...
- Contraindications to the use of MEOPA
- Nasal breathing disorders such as a flu syndrome ("blocked nose" not allowing nasal ventilation)
- Hearing impaired children
- Patients with complications during inhalation (especially headaches)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Lille University hospital
Lille, France, 59000
Not Yet Recruiting
2
Marseille University hospital
Marseille, France, 13000
Not Yet Recruiting
3
Nice University Hospital
Nice, France, 06000
Actively Recruiting
4
Toulouse University hospital
Toulouse, France, 31000
Actively Recruiting
Research Team
M
Michele MULLER BOLLA, PUPH
CONTACT
E
Elodie Ayem, PH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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