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

NCT03925571 | Completed

• 1 other identifier: RC17_0289
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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

Conditions

Dental Pain and Sensation Disorders

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  the pain intensity will be measured with the Visual analogue scale (VAS).

  24 hours after the dental surgery

Secondary Outcomes (1)

• Efficacy of musicotherapy

  24, 48 and 72 hours

Study Arms (2)

music-listening group

EXPERIMENTAL

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

Other: musicotherapy

non music-listening group

NO INTERVENTION

patient will receive their dental intervention without music-listening.

Interventions

musicotherapy 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…).

music-listening group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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®.

Sponsors & Collaborators

• Nantes University Hospital: lead
• Fondation Apicil: collaborator

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

Toothache; Sensation Disorders

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Study Officials

• Assem Soueidan, Pr

  Nantes University Hospital

  STUDY CHAIR

• Olivier Bonnot, Pr

  Nantes University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 24, 2019
• Study Start: May 3, 2019
• Primary Completion: May 3, 2021
• Study Completion: May 3, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-10

Locations

FR (1)