Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
177 participants
INTERVENTIONAL
2023-03-10
2025-09-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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MEOPA dental care with music
diffusion of relaxing music during dental care under MEOPA
using relaxing music
music diffusion during dental care under MEOPA
MEOPA dental care without music
dental care under MEOPA as usual
No relaxing music
dental care under MEOPA without music
Interventions
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using relaxing music
music diffusion during dental care under MEOPA
No relaxing music
dental care under MEOPA without music
Eligibility Criteria
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Inclusion Criteria
* 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
* Nasal breathing disorders such as a flu syndrome ("blocked nose" not allowing nasal ventilation)
* Hearing impaired children
* Patients with complications during inhalation (especially headaches)
4 Years
12 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Locations
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Lille University hospital
Lille, , France
Marseille University hospital
Marseille, , France
Nice University Hospital
Nice, , France
Toulouse University hospital
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20-API-03
Identifier Type: -
Identifier Source: org_study_id
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