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

Dental Pain and Sensation Disorders Clinical Trial

— MUSANX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03925571
• Other study ID #: RC17_0289
• Status: Completed
• Phase: N/A
• 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
• 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®.

Related Conditions & MeSH terms

• Dental Pain and Sensation Disorders
• Pain, Postoperative
• Sensation Disorders

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