Music During Dental Children Care Under MEOPA

NCT05720689 | Active Not Recruiting

• 1 other identifier: 20-API-03
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 6

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.

Conditions

Dental Diseases

Outcome Measures

Primary Outcomes (1)

• Success of sedation (binary) according to the Venham scale modified by Veerkamp

  (success: scores 0-1-2; failure: scores 3-4-5)

  1 day

Study Arms (2)

MEOPA dental care with music

EXPERIMENTAL

diffusion of relaxing music during dental care under MEOPA

Other: using relaxing music

MEOPA dental care without music

ACTIVE COMPARATOR

dental care under MEOPA as usual

Other: No relaxing music

Interventions

using relaxing music OTHER

music diffusion during dental care under MEOPA

MEOPA dental care with music

No relaxing music OTHER

dental care under MEOPA without music

MEOPA dental care without music

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (6)

Lille University hospital

Lille, 59000, France

Location

Marseille University hospital

Marseille, 13000, France

Location

Nantes University hospital

Nantes, France

Location

Nice University Hospital

Nice, 06000, France

Location

Rennes University Hospital

Rennes, France

Location

Toulouse University hospital

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intra-individual comparison by cross-over

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: March 10, 2023
• Primary Completion: May 21, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)