Music During Dental Children Care Under MEOPA

Not Applicable

Recruiting

• Conditions: Dental Diseases
• Interventions: Other: using relaxing music; Other: No relaxing music

• Registration Number: NCT05720689
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-31
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-09
• Study Start: 2023-03-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17
• Primary Completion: 2025-02-20
• Study Completion: 2025-09-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 177

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MEOPA dental care with music	using relaxing music	diffusion of relaxing music during dental care under MEOPA
MEOPA dental care without music	No relaxing music	dental care under MEOPA as usual

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (4)

Toulouse University hospital; 🇫🇷 Toulouse, France

Marseille University hospital; 🇫🇷 Marseille, France

Lille University hospital; 🇫🇷 Lille, France

Nice University Hospital; 🇫🇷 Nice, France