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NCT Number: NCT05720689

Music During Dental Children Care Under MEOPA

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lille University hospital, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

using relaxing music

Other

music diffusion during dental care under MEOPA

No relaxing music

Other

dental care under MEOPA without music

Primary outcomes

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

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Contribution of Music During Dental Care Under MEOPA in Children

Acronym: SONOMEOPAeDENT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2023
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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