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Music During Dental Children Care Under MEOPA

Study acronym: SONOMEOPAeDENT
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date changed from estimate of Feb 20, 2025 to May 21, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 4 to 6
    • Study completion date: Sep 20, 2025 to Sep 20, 2026
    v5
  2. Minor Re-verified, no change to tracked fieldsv4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 20, 2023 to Mar 10, 2023
    • Site details revised at 4 of 4 sites
    v3
  4. Minor Re-verified, no change to tracked fieldsv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05720689
Lead Sponsor Centre Hospitalier Universitaire de Nice
Conditions
(from sponsor)
Dental Diseases
Related terms Stomatognathic Diseases
Enrollment 177 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov