Music During Dental Children Care Under MEOPA (SONOMEOPAeDENT)

Contribution of Music During Dental Care Under MEOPA in Children

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Diseases
• Intervention / Treatment: Other: using relaxing music; Other: No relaxing music

• Study Type: Interventional
• Enrollment (Actual): 177
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59000
    • Lille University Hospital
  • Marseille, France, 13000
    • Marseille University hospital
  • Nantes, France
    • Nantes University Hospital
  • Nice, France, 06000
    • Nice University Hospital
  • Rennes, France
    • Rennes University Hospital
  • Toulouse, France, 31000
    • Toulouse University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MEOPA dental care with music; diffusion of relaxing music during dental care under MEOPA	Other: using relaxing music; music diffusion during dental care under MEOPA
Active Comparator: MEOPA dental care without music; dental care under MEOPA as usual	Other: No relaxing music; dental care under MEOPA without music

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of sedation (binary) according to the Venham scale modified by Veerkamp	(success: scores 0-1-2; failure: scores 3-4-5)	1 day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Actual): May 21, 2026
• Study Completion (Estimated): September 20, 2026

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: January 31, 2023
• First Posted (Actual): February 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases
• Other Study ID Numbers: 20-API-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No