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Trial record 32 of 82 for:    Taste Disorders AND sense

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

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ClinicalTrials.gov Identifier: NCT03925571
Recruitment Status : Not yet recruiting
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
Fondation Apicil
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Dental Pain and Sensation Disorders Other: musicotherapy Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : April 15, 2020

Resource links provided by the National Library of Medicine


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.



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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years 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®.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925571


Contacts
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Contact: Assem Soueidan, Pr 02.40.08.73.83 ext +33 assem.soueidan@chu-nantes.fr
Contact: Marjorie Cheraud-Carpentier 02.40.08.73.83 ext +33 Marjorie.CHERAUDCARPENTIER@chu-nantes.fr

Locations
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France
Nantes University Hospital Not yet recruiting
Nantes, France, 44093
Contact: Assem Soueidan, Pr    02.40.08.73.83 ext +33    assem.soueidan@chu-nantes.fr   
Contact: Marjorie Cheraud-Carpentier    02.40.08.73.83 ext +33    Marjorie.cheraudcarpentier@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Fondation Apicil
Investigators
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Study Chair: Assem Soueidan, Pr Nantes University Hospital
Study Director: Olivier Bonnot, Pr Nantes University Hospital

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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: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Toothache
Sensation Disorders
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Nervous System Diseases