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Music During Dental Children Care Under MEOPA

Contribution of Music During Dental Care Under MEOPA in Children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05720689
Acronym
SONOMEOPAeDENT
Enrollment
177
Registered
2023-02-09
Start date
2023-03-10
Completion date
2026-09-20
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Diseases

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.

Interventions

OTHERusing relaxing music

music diffusion during dental care under MEOPA

OTHERNo relaxing music

dental care under MEOPA without music

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Intervention model description

Intra-individual comparison by cross-over

Eligibility

Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Success of sedation (binary) according to the Venham scale modified by Veerkamp1 day(success: scores 0-1-2; failure: scores 3-4-5)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026