Clinical trial NCT05720689: Music During Dental Children Care Under MEOPA
Official title: Contribution of Music During Dental Care Under MEOPA in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Diseases
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-02-09
Enrollment: 177
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Intra-individual comparison by cross-over
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Success of sedation (binary) according to the Venham scale modified by Veerkamp
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Lille University hospital
city: Marseille
country: France
facility: Marseille University hospital
city: Nice
country: France
facility: Nice University Hospital
city: Toulouse
country: France
facility: Toulouse University hospital
Study officials:
References: