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Music During Dental Children Care Under MEOPA (SONOMEOPAeDENT)

Primary Purpose

Dental Diseases

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
using relaxing music
No relaxing music
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dental Diseases

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Lille University hospital
  • Marseille University hospital
  • Nice University HospitalRecruiting
  • Toulouse University hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MEOPA dental care with music

MEOPA dental care without music

Arm Description

diffusion of relaxing music during dental care under MEOPA

dental care under MEOPA as usual

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 31, 2023
Last Updated
May 5, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT05720689
Brief Title
Music During Dental Children Care Under MEOPA
Acronym
SONOMEOPAeDENT
Official Title
Contribution of Music During Dental Care Under MEOPA in Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
February 20, 2025 (Anticipated)
Study Completion Date
September 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Diseases

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Intra-individual comparison by cross-over
Masking
None (Open Label)
Allocation
Randomized
Enrollment
177 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MEOPA dental care with music
Arm Type
Experimental
Arm Description
diffusion of relaxing music during dental care under MEOPA
Arm Title
MEOPA dental care without music
Arm Type
Active Comparator
Arm Description
dental care under MEOPA as usual
Intervention Type
Other
Intervention Name(s)
using relaxing music
Intervention Description
music diffusion during dental care under MEOPA
Intervention Type
Other
Intervention Name(s)
No relaxing music
Intervention Description
dental care under MEOPA without music
Primary Outcome Measure Information:
Title
Success of sedation (binary) according to the Venham scale modified by Veerkamp
Description
(success: scores 0-1-2; failure: scores 3-4-5)
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michele MULLER BOLLA, PUPH
Phone
0610823276
Email
muller@unice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie Ayem, PH
Phone
0610823276
Email
eloaiem@hotmail.com
Facility Information:
Facility Name
Lille University hospital
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
caroline Delfosse, PH
Email
caroline.delfosse@univ-lille.fr
First Name & Middle Initial & Last Name & Degree
Thomas Marquillier, PH
Email
thomas.marquillier@univ-lille.fr
First Name & Middle Initial & Last Name & Degree
caroline Delfosse
First Name & Middle Initial & Last Name & Degree
thomas Marquillier
Facility Name
Marseille University hospital
City
Marseille
ZIP/Postal Code
13000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ariane Camoin, PH
Email
ariane.camoin@gmail.com
First Name & Middle Initial & Last Name & Degree
Corine Tardieu, PH
Email
corinne.tardieu@univ-amu.fr
First Name & Middle Initial & Last Name & Degree
ariane Camoin
First Name & Middle Initial & Last Name & Degree
corinne Tardieu
Facility Name
Nice University Hospital
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
michele Muler Bolla, PUPH
Phone
0610823276
Email
muller@unice.fr
First Name & Middle Initial & Last Name & Degree
elodie Ayem, ph
Phone
0610823276
Email
eloaiem@hotmail.com
First Name & Middle Initial & Last Name & Degree
michele MULLER BOLLA
First Name & Middle Initial & Last Name & Degree
Elodie AYEM
Facility Name
Toulouse University hospital
City
Toulouse
ZIP/Postal Code
31000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu Marty, PH
Email
mathieu.marty@univ-tlse3.fr
First Name & Middle Initial & Last Name & Degree
Emmanuelle Noirrit-Esclassan, PUPH
Email
noirrit.e@odonto-tlse.eu
First Name & Middle Initial & Last Name & Degree
mathieu Marty
First Name & Middle Initial & Last Name & Degree
Emmanuelle Noirrit-Esclassan

12. IPD Sharing Statement

Plan to Share IPD
No

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Music During Dental Children Care Under MEOPA

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