Trials / Recruiting
RecruitingNCT05720689
Music During Dental Children Care Under MEOPA
Contribution of Music During Dental Care Under MEOPA in Children
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 177 (estimated)
- Sponsor
- Centre Hospitalier Universitaire de Nice · Academic / Other
- Sex
- All
- Age
- 4 Years – 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | using relaxing music | music diffusion during dental care under MEOPA |
| OTHER | No relaxing music | dental care under MEOPA without music |
Timeline
- Start date
- 2023-03-10
- Primary completion
- 2025-02-20
- Completion
- 2025-09-20
- First posted
- 2023-02-09
- Last updated
- 2024-05-17
Locations
4 sites across 1 country: France
Source: ClinicalTrials.gov record NCT05720689. Inclusion in this directory is not an endorsement.