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

NCT ID: NCT03925571

Last Updated: 2021-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-03
• Study Completion Date: 2021-05-03

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

music-listening group

patient will listen to music during the dental surgery (1 to 1h30 hours).

Group Type: EXPERIMENTAL

musicotherapy

Intervention Type: OTHER

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…).

non music-listening group

patient will receive their dental intervention without music-listening.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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…).

Intervention Type: OTHER

Eligibility Criteria

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®.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Apicil

OTHER

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Assem Soueidan, Pr

Role: STUDY_CHAIR

Nantes University Hospital

Olivier Bonnot, Pr

Role: STUDY_DIRECTOR

Nantes University Hospital

Locations

Nantes University Hospital

Nantes, , France

Countries

France

Other Identifiers

RC17_0289

Identifier Type: -

Identifier Source: org_study_id