Dental Pain and Sensation DisordersMUSANXNCT03925571
Musicotherapy in Reducing Peroperative Anxiety and Post-surgical Pain in Dental Care
A study testing musicotherapy in people with Dental Pain and Sensation Disorders, run by Nantes University Hospital at 1 site in France.
Trial summary
The main purpose of MUSANX study is to highlight analgesic effectiveness of musicotherapy in post-surgical periodontal and implant; and to measure its per-operative anxiolytic effectiveness Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Dental Pain and Sensation Disorders
- What is being tested?
- musicotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 3 May 2019to 3 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Majors aged between 18 and 55 years, with an appropriate hearing and able to use Music-Care© (selection of the playlist via internet access),
- Needing treatment in odontology - periodontal surgery (coronary elongation or sanitation surgery or muco-gingival surgery) or implantary surgery (placement of an unit implant or two implant in the same localization),
- Oral and dated consent,
- Agreeing to be contacted via phone at J+1 and to fill follow-up study documents,
- Profiting of social security or CMU.
Who cannot join
- Patients with a long-term taking of anxiolytic or analgesic,
- Regular consumer of soft drug (cannabis) or hard drug (opioid),
- Patient with medical history of psychiatry (mental harm), hearing problem, cognitive and behavioural impairment (claustrophobia), sensory disabilities,
- Patient with problems of hemostasis,
- Majors under trusteeship or guardianship,
- Pregnant women or lactating,
Show all 13Show fewer
- Minors,
- Protected person, deprived of freedom or under justice safeguard,
- Profiting of a medical help from government (AME),
- Not contactable after care,
- Patient with hepatic impairment,
- Patient with dry mouth,
- Patient relevant a suboptimal hearing incompatible with musicotherapy or inability to use Music-care®.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Musicotherapy in Reducing Peroperative Anxiety and Post-surgical Pain in Dental Care
The main purpose of MUSANX study is to highlight analgesic effectiveness of musicotherapy in post-surgical periodontal and implant; and to measure its per-operative anxiolytic effectiveness
Read the detailed description
This study will be on music use as musicotherapy "receptive " or " passive ", using hearing aid for listening in order to relax and reduce the anxiety and pain state of the patient. This care will be focused on the acute stress and pain during the dental care.
Another major secondary purpose will consist to explore the anxiolytic effect of the musicotherapy on diverse stress markers such as heart rate, respiratory rate, salivary cortisol ratio and electro-dermal intensity (RED).
- Conditions
- Dental Pain and Sensation Disorders
- Being tested
- musicotherapy
- Medical subject headings
- Toothache, Sensation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musicotherapyOther
If the patient is randomized in the experimental group, he listens the Music-care® playlists and chose two closed to his musical tastes. The playlists are unique compositions create by Music-care® (french company), not known from the general public, categorized by theme (jazz, rock, world music…).
| Study group | Role | What they receive |
|---|---|---|
| music-listening group | Experimental | patient will listen to music during the dental surgery (1 to 1h30 hours). Receives: Other: musicotherapy |
| non music-listening group | No intervention | patient will receive their dental intervention without music-listening. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
the pain intensity will be measured with the Visual analogue scale (VAS).
Measured: 24 hours after the dental surgery
Secondary outcomes (1)
Efficacy of musicotherapy
Evaluate the anxiolytic effectiveness of " passive " musicotherapy on the reduction of peroperative anxiety during the dental surgery by STAY questionnaire
Measured: 24, 48 and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start3 May 2019
- Primary completion3 May 2021
- Study completion3 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pain and Sensation DisordersStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Apicil
- Responsible party
- Sponsor
- Investigators
- Assem Soueidan, Pr, Study chair, Nantes University HospitalOlivier Bonnot, Pr, Study director, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925571
- Sponsor's protocol ID
- RC17_0289
- Acronym
- MUSANX
- Status last verified
- Oct 2021
- First submitted
- 8 Apr 2019
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Musicotherapy in Reducing Peroperative Anxiety and Post-surgical Pain in Dental Care
- ClinicalTrials.gov ID
- NCT03925571
- Acronym / sponsor ID
- MUSANX / RC17_0289
- Conditions
- Dental Pain and Sensation Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Fondation Apicil
- Study start
- 3 May 2019 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 24 Apr 2019 (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.
The main purpose of MUSANX study is to highlight analgesic effectiveness of musicotherapy in post-surgical periodontal and implant; and to measure its per-operative anxiolytic effectiveness
Detailed description
This study will be on music use as musicotherapy "receptive " or " passive ", using hearing aid for listening in order to relax and reduce the anxiety and pain state of the patient. This care will be focused on the acute stress and pain during the dental care.
Another major secondary purpose will consist to explore the anxiolytic effect of the musicotherapy on diverse stress markers such as heart rate, respiratory rate, salivary cortisol ratio and electro-dermal intensity (RED).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| music-listening group | Experimental | Other: musicotherapypatient will listen to music during the dental surgery (1 to 1h30 hours). |
| non music-listening group | No intervention | –patient will receive their dental intervention without music-listening. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Majors aged between 18 and 55 years, with an appropriate hearing and able to use Music-Care© (selection of the playlist via internet access),
- Needing treatment in odontology - periodontal surgery (coronary elongation or sanitation surgery or muco-gingival surgery) or implantary surgery (placement of an unit implant or two implant in the same localization),
- Oral and dated consent,
- Agreeing to be contacted via phone at J+1 and to fill follow-up study documents,
- Profiting of social security or CMU.
Key exclusion criteria (13 listed)
- Patients with a long-term taking of anxiolytic or analgesic,
- Regular consumer of soft drug (cannabis) or hard drug (opioid),
- Patient with medical history of psychiatry (mental harm), hearing problem, cognitive and behavioural impairment (claustrophobia), sensory disabilities,
- Patient with problems of hemostasis,
- Majors under trusteeship or guardianship,
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 |
|---|---|---|
| musicotherapyIf the patient is randomized in the experimental group, he listens the Music-care® playlists and chose two closed to his musical tastes. The playlists are unique compositions create by Music-care® (french company), not known from the general public, categorized by theme (jazz, rock, world music…). | Other | music-listening group |
Primary outcome
Pain intensity
Time frame: 24 hours after the dental surgery
the pain intensity will be measured with the Visual analogue scale (VAS).
1 secondary outcome
Efficacy of musicotherapy
Time frame: 24, 48 and 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Dental Pain and Sensation Disorders
Not yet recruiting
Photobiomodulation After Nonsurgical Root Canal Treatment
Symptomatic Apical Periodontitis, Postoperative Pain
RecruitingPhase 4
Efficacy of Preoperative Administration of Gabapentin in 3rd Molar Dental Extraction.
Dental Pain and Sensation Disorder, Pain, Postoperative
Enrolling by invitation
Comparison of Post Cementation Sensitivity Between RMGIC and GIC as Luting Materials in a Randomized Clinical Trial
Dental Pulp Disease, Dental Pain and Sensation Disorder
Not yet recruitingPhase 4
Meloxicam Versus Ibuprofen for Pain Control After Third Molar Exodontia in Adult Patients
Dental Pain, Sensation Disorders
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.
Assem Soueidan, Pr study chair
Nantes University Hospital
Olivier Bonnot, Pr study director
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing musicotherapy in people with Dental Pain and Sensation Disorders, run by Nantes University Hospital at 1 site 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 13 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: finished, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain intensity (time frame: 24 hours after the dental surgery). 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 4 Oct 2021.