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

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

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

Study Overview

• Status: Completed
• Conditions: Dental Pain and Sensation Disorders
• Intervention / Treatment: Other: musicotherapy

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).

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Fondation Apicil
• Investigators: Study Chair: Assem Soueidan, Pr, Nantes University Hospital; Study Director: Olivier Bonnot, Pr, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2019
• Primary Completion (Actual): May 3, 2021
• Study Completion (Actual): May 3, 2021

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: October 1, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Sensation Disorders
• Other Study ID Numbers: RC17_0289

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No