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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03925571

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted December 23, 2020

Study Description

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

  • Condition or Disease:Dental Pain and Sensation Disorders
  • Intervention/Treatment: Other: musicotherapy
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 68 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Supportive Care
  • Official Title: Evaluation of the Effectiveness of Musicotherapy in Reducing Peroperative Anxiety and Post-surgical Pain in Dental Care
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: November 2021
  • Estimated Study Completion Date: November 2021
Arms and interventions
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…).
Outcome Measures
  • Primary Outcome Measures: 1. Pain intensity [ Time Frame: 24 hours after the dental surgery ]
    the pain intensity will be measured with the Visual analogue scale (VAS).
  • Secondary Outcome Measures: 1. Efficacy of musicotherapy [ Time Frame: 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
Eligibility Criteria
  • Ages Eligible for Study: 18 to 55 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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®.

Contacts and Locations
Contacts

Contact: Assem Soueidan, Pr 02.40.08.73.83 ext +33 assem.soueidan@chu-nantes.fr

Contact: Octave Bandiaky 02.40.08.73.83 ext +33 octave.bandiaky@chu-nantes.fr

Locations

France
Nantes University Hospital
Nantes

Sponsors and Collaborators

Nantes University Hospital

Fondation Apicil

Investigators

Study Chair: Assem Soueidan, Pr Nantes University Hospital

Study Director: Olivier Bonnot, Pr Nantes University Hospital

More Information
  • Responsible Party: Nantes University Hospital
  • ClinicalTrials.gov Identifier: NCT03925571 History of Changes
  • Other Study ID Numbers: RC17_0289
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: December 23, 2020
  • Last Verified: December 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Sensation Disorders