Using music to help children during dental care with sedation
Contribution of Music During Dental Care Under MEOPA in Children
This study is testing whether playing relaxing music can help children aged 4 to 12 feel less anxious and have a better experience during dental care while they are sedated.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 177 (estimated) |
| Ages | 4 Years to 12 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 4 sites (Lille and 3 other locations) |
| Trial ID | NCT05720689 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of relaxing music on children aged 4 to 12 years receiving dental care under conscious sedation with an equimolar mixture of oxygen and nitrous oxide (MEOPA). The study aims to improve the dental care experience for children, particularly those with special needs or anxiety, by assessing whether music can enhance anxiolysis and overall treatment success. Participants will be recruited from four university hospital dental services in France, and the trial will compare outcomes between sessions with and without music.
Who should consider this trial
Good fit: Ideal candidates are children aged 4 to 12 years who require dental care under sedation and can communicate in French.
Not a fit: Patients with contraindications to MEOPA, nasal breathing disorders, hearing impairments, or those who have had complications during inhalation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce anxiety and improve the dental care experience for children, leading to better oral health outcomes.
How similar studies have performed: While the use of music in medical settings is not novel, specific studies focusing on its impact during pediatric dental procedures under sedation are limited, making this approach relatively untested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Lille and 3 other locations
- Lille University hospital — Lille, France (Not_yet_recruiting)
- Marseille University hospital — Marseille, France (Not_yet_recruiting)
- Nice University Hospital — Nice, France (Recruiting)
- Toulouse University hospital — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Michele MULLER BOLLA, PUPH
- Email: muller@unice.fr
- Phone: 0610823276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.