Music During Dental Children Care Under MEOPA

NCT ID: NCT05720689

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-10

Study Completion Date

2025-09-20

Brief Summary

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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

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Conditions

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Dental Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Intra-individual comparison by cross-over
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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MEOPA dental care with music

diffusion of relaxing music during dental care under MEOPA

Group Type EXPERIMENTAL

using relaxing music

Intervention Type OTHER

music diffusion during dental care under MEOPA

MEOPA dental care without music

dental care under MEOPA as usual

Group Type ACTIVE_COMPARATOR

No relaxing music

Intervention Type OTHER

dental care under MEOPA without music

Interventions

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using relaxing music

music diffusion during dental care under MEOPA

Intervention Type OTHER

No relaxing music

dental care under MEOPA without music

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lille University hospital

Lille, , France

Site Status NOT_YET_RECRUITING

Marseille University hospital

Marseille, , France

Site Status NOT_YET_RECRUITING

Nice University Hospital

Nice, , France

Site Status RECRUITING

Toulouse University hospital

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Michele MULLER BOLLA, PUPH

Role: CONTACT

0610823276

Elodie Ayem, PH

Role: CONTACT

0610823276

Facility Contacts

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caroline Delfosse, PH

Role: primary

Thomas Marquillier, PH

Role: backup

Ariane Camoin, PH

Role: primary

Corine Tardieu, PH

Role: backup

michele Muler Bolla, PUPH

Role: primary

0610823276

elodie Ayem, ph

Role: backup

0610823276

Mathieu Marty, PH

Role: primary

Emmanuelle Noirrit-Esclassan, PUPH

Role: backup

Other Identifiers

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20-API-03

Identifier Type: -

Identifier Source: org_study_id

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