Actively Recruiting

Phase Not Applicable
Age: 4Years - 12Years
All Genders
NCT05720689

Music During Dental Children Care Under MEOPA

Led by Centre Hospitalier Universitaire de Nice · Updated on 2024-05-17

177

Participants Needed

4

Research Sites

132 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Music During Dental Children Care Under MEOPA

Who Can Participate

Age: 4Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Lille University hospital

Lille, France, 59000

Not Yet Recruiting

2

Marseille University hospital

Marseille, France, 13000

Not Yet Recruiting

3

Nice University Hospital

Nice, France, 06000

Actively Recruiting

4

Toulouse University hospital

Toulouse, France, 31000

Actively Recruiting

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Research Team

M

Michele MULLER BOLLA, PUPH

CONTACT

E

Elodie Ayem, PH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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Music During Dental Children Care Under MEOPA | DecenTrialz