Musicotherapy in Reducing Peroperative Anxiety and Post-surgical Pain in Dental Care

Study Overview
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Brief Summary
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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
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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).

Official Title
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Evaluation of the Effectiveness of Musicotherapy in Reducing Peroperative Anxiety and Post-surgical Pain in Dental Care

Conditions
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Dental Pain and Sensation Disorders

Intervention / Treatment
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* Other: musicotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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, 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®.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: music-listening group<br>patient will listen to music during the dental surgery (1 to 1h30 hours). | Other: musicotherapy<br>* 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…).<br>|
| No Intervention: non music-listening group<br>patient will receive their dental intervention without music-listening. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | the pain intensity will be measured with the Visual analogue scale (VAS). | 24 hours after the dental surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of musicotherapy | Evaluate the anxiolytic effectiveness of  passive  musicotherapy on the reduction of peroperative anxiety during the dental surgery by STAY questionnaire | 24, 48 and 72 hours |