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

Not Applicable

Completed

• Conditions: Dental Pain and Sensation Disorders
• Interventions: Other: musicotherapy

• Registration Number: NCT03925571
• Lead Sponsor: Nantes University Hospital

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).

Study Timeline

• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-24
• Study Start: 2019-05-03
• Primary Completion: 2021-05-03
• Study Completion: 2021-05-03
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-01
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
music-listening group	musicotherapy	patient will listen to music during the dental surgery (1 to 1h30 hours).

Primary Outcome Measures

Name	Time	Method
Pain intensity	24 hours after the dental surgery	the pain intensity will be measured with the Visual analogue scale (VAS).

Secondary Outcome Measures

Name	Time	Method
Efficacy of musicotherapy	24, 48 and 72 hours	Evaluate the anxiolytic effectiveness of " passive " musicotherapy on the reduction of peroperative anxiety during the dental surgery by STAY questionnaire

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France