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出境医 / 临床实验 / Musicotherapy in Reducing Peroperative Anxiety and Post-surgical Pain in Dental Care (MUSANX)
Musicotherapy in Reducing Peroperative Anxiety and Post-surgical Pain in Dental Care (MUSANX)
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 | 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).
Study Design
| 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 |
| Actual Study Start Date : | May 3, 2019 |
| Estimated Primary Completion Date : | November 15, 2021 |
| Estimated Study Completion Date : | November 15, 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…).
|
|
No Intervention: non music-listening group
patient will receive their dental intervention without music-listening.
|
Outcome Measures
Primary Outcome Measures :
- 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 :
- 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 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®.
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 | Recruiting |
| Nantes, France, 44093 | |
| 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 | |
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 |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 8, 2019 | ||||||||
| First Posted Date ICMJE | April 24, 2019 | ||||||||
| Last Update Posted Date | December 23, 2020 | ||||||||
| Actual Study Start Date ICMJE | May 3, 2019 | ||||||||
| Estimated Primary Completion Date | November 15, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Pain intensity [ Time Frame: 24 hours after the dental surgery ] the pain intensity will be measured with the Visual analogue scale (VAS).
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Musicotherapy in Reducing Peroperative Anxiety and Post-surgical Pain in Dental Care | ||||||||
| Official Title ICMJE | Evaluation of the Effectiveness of Musicotherapy in Reducing Peroperative Anxiety and Post-surgical Pain in Dental Care | ||||||||
| 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 Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
||||||||
| Condition ICMJE | Dental Pain and Sensation Disorders | ||||||||
| Intervention ICMJE | 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…).
|
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| Study Arms ICMJE |
|
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
68 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | November 15, 2021 | ||||||||
| Estimated Primary Completion Date | November 15, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years to 55 Years (Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03925571 | ||||||||
| Other Study ID Numbers ICMJE | RC17_0289 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Nantes University Hospital | ||||||||
| Study Sponsor ICMJE | Nantes University Hospital | ||||||||
| Collaborators ICMJE | Fondation Apicil | ||||||||
| Investigators ICMJE |
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| PRS Account | Nantes University Hospital | ||||||||
| Verification Date | December 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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