Dental DiseasesSONOMEOPAeDENTNCT05720689
Music During Dental Children Care Under MEOPA
A study testing using relaxing music and No relaxing music in people with Dental Diseases, run by Centre Hospitalier Universitaire de Nice at 6 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Dental Diseases
- What is being tested?
- using relaxing music and No relaxing music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 6 sitesFrance
- Study dates
- 10 Mar 2023to 20 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Lille University hospital
Lille, 59000
Marseille University hospital
Marseille, 13000
Nantes University hospital
Nantes
Nice University Hospital
Nice, 06000
Rennes University Hospital
Rennes
Toulouse University hospital
Toulouse, 31000
About this study
Official title: 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.
- Conditions
- Dental Diseases
- Being tested
- using relaxing music, No relaxing music
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using relaxing musicOther
music diffusion during dental care under MEOPA
No relaxing musicOther
dental care under MEOPA without music
| Study group | Role | What they receive |
|---|---|---|
| MEOPA dental care with music | Experimental | diffusion of relaxing music during dental care under MEOPA Receives: Other: using relaxing music |
| MEOPA dental care without music | Active comparator | dental care under MEOPA as usual Receives: Other: No relaxing music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of sedation (binary) according to the Venham scale modified by Veerkamp
(success: scores 0-1-2; failure: scores 3-4-5)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start10 Mar 2023
- Primary completion21 May 2026
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Intra-individual comparison by cross-over
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720689
- Sponsor's protocol ID
- 20-API-03
- Acronym
- SONOMEOPAeDENT
- Status last verified
- May 2026
- First submitted
- 31 Jan 2023
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Music During Dental Care Under MEOPA in Children
- ClinicalTrials.gov ID
- NCT05720689
- Acronym / sponsor ID
- SONOMEOPAeDENT / 20-API-03
- Conditions
- Dental Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intra-individual comparison by cross-over
| Arm | Type | Receives |
|---|---|---|
| MEOPA dental care with music | Experimental | Other: using relaxing musicdiffusion of relaxing music during dental care under MEOPA |
| MEOPA dental care without music | Active comparator | Other: No relaxing musicdental care under MEOPA as usual |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| using relaxing musicmusic diffusion during dental care under MEOPA | Other | MEOPA dental care with music |
| No relaxing musicdental care under MEOPA without music | Other | MEOPA dental care without music |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
Related trials for Dental Diseases
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing using relaxing music and No relaxing music in people with Dental Diseases, run by Centre Hospitalier Universitaire de Nice at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of sedation (binary) according to the Venham scale modified by Veerkamp (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.