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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03925571
Other study ID # RC17_0289
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 3, 2019
Est. completion date May 3, 2021

Study information

Verified date October 2021
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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).


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date May 3, 2021
Est. primary completion date May 3, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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®.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
musicotherapy
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…).

Locations

Country Name City State
France Nantes University Hospital Nantes

Sponsors (2)

Lead Sponsor Collaborator
Nantes University Hospital Fondation Apicil

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity the pain intensity will be measured with the Visual analogue scale (VAS). 24 hours after the dental surgery
Secondary 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