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

Primary Purpose

Dental Pain and Sensation Disorders

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
musicotherapy
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dental Pain and Sensation Disorders

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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®.

Sites / Locations

  • Nantes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

music-listening group

non music-listening group

Arm Description

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

patient will receive their dental intervention without music-listening.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Efficacy of musicotherapy
Evaluate the anxiolytic effectiveness of " passive " musicotherapy on the reduction of peroperative anxiety during the dental surgery by STAY questionnaire

Full Information

First Posted
April 8, 2019
Last Updated
October 1, 2021
Sponsor
Nantes University Hospital
Collaborators
Fondation Apicil
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1. Study Identification

Unique Protocol Identification Number
NCT03925571
Brief Title
Musicotherapy in Reducing Peroperative Anxiety and Post-surgical Pain in Dental Care
Acronym
MUSANX
Official Title
Evaluation of the Effectiveness of Musicotherapy in Reducing Peroperative Anxiety and Post-surgical Pain in Dental Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 3, 2019 (Actual)
Primary Completion Date
May 3, 2021 (Actual)
Study Completion Date
May 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
Collaborators
Fondation Apicil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pain and Sensation Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
music-listening group
Arm Type
Experimental
Arm Description
patient will listen to music during the dental surgery (1 to 1h30 hours).
Arm Title
non music-listening group
Arm Type
No Intervention
Arm Description
patient will receive their dental intervention without music-listening.
Intervention Type
Other
Intervention Name(s)
musicotherapy
Intervention Description
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…).
Primary Outcome Measure Information:
Title
Pain intensity
Description
the pain intensity will be measured with the Visual analogue scale (VAS).
Time Frame
24 hours after the dental surgery
Secondary Outcome Measure Information:
Title
Efficacy of musicotherapy
Description
Evaluate the anxiolytic effectiveness of " passive " musicotherapy on the reduction of peroperative anxiety during the dental surgery by STAY questionnaire
Time Frame
24, 48 and 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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®.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assem Soueidan, Pr
Organizational Affiliation
Nantes University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Olivier Bonnot, Pr
Organizational Affiliation
Nantes University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Nantes University Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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