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Active, not recruiting Not applicable

Music During Dental Children Care Under MEOPA

NCT05720689 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-03-10
Last updated
2026-05-26

Condition(s) studied

Dental Diseases

Investigational drug(s) / intervention(s)

using relaxing musicNo relaxing music

using relaxing music: music diffusion during dental care under MEOPA

No relaxing music: dental care under MEOPA without music

Study 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

Sex
ALL
Min age
4 Years
Max age
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)

Primary outcome measure(s)

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

Trial sites (6)

FacilityCityRegionStatus
Lille University hospital Lille France
Marseille University hospital Marseille France
Nantes University hospital Nantes France
Nice University Hospital Nice France
Rennes University Hospital Rennes France
Toulouse University hospital Toulouse France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05720689 on ClinicalTrials.gov ↗ ← All trials in France