Music During Dental Children Care Under MEOPA (SONOMEOPAeDENT)

Centre Hospitalier Universitaire de Nice

Status: Enrolling

Conditions: Dental Diseases

Treatments: Other: No relaxing music; Other: using relaxing music

Study type: Interventional

Funder types: Other

Identifiers

NCT05720689

20-API-03

Details and patient eligibility

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.

Enrollment: 177 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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177 participants in 2 patient groups

MEOPA dental care with music

Experimental group

Description:

diffusion of relaxing music during dental care under MEOPA

Treatment:

Other: using relaxing music

MEOPA dental care without music

Active Comparator group

Description:

dental care under MEOPA as usual

Treatment:

Other: No relaxing music