Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2018-10-12
2020-03-21
Brief Summary
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This experimental clinical trial examines the effect of personalized musical intervention on the burden of dental implant surgery. The intervention consists of a personnalized musical intervention and the control group consists of audio books. The burden of dental implant surgery will be defined by a composite variable including surgical pain, state anxiety and dissatisfaction with dental implant surgery.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Intervention group: Personalized music
This arm will receive an intervention which will be personalized music. It will be provided by Music Care application (https://www.music-care.com/fr).
Personalized music
Patients in the intervention group will listen to personalized music from the Musicare application
Control: Audio Books
Control will consist of audio books.
Audio Books
Patients in the active comparator group will listen to audio books
Interventions
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Personalized music
Patients in the intervention group will listen to personalized music from the Musicare application
Audio Books
Patients in the active comparator group will listen to audio books
Eligibility Criteria
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Inclusion Criteria
* will have an adequate understanding of the French or English language both written and spoken,
* will have the physical and psychological ability to understand and complete the questionnaires used in the study,
* will consent to follow research instructions,
* will consent to follow the allocated sequence of interventions without prior notification,
* will undergo a dental implant surgery not exceeding 2 hours,
Exclusion Criteria
* do not have the necessary clinical criteria to receive implants.
* have an implant surgical treatment that would increase treatment time beyond 2 hours,
* have a history of neurological disorders, diagnosed with severe psychiatric disorders (e.g. schizophrenia, bipolar disorder), substance abuse
* have a major diagnosed hearing problem.
18 Years
100 Years
ALL
Yes
Sponsors
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Université de Montréal
OTHER
Responsible Party
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Nathalie Gosselin
PhD, Neuropsychologist
Principal Investigators
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Nathalie Gosselin, PhD
Role: PRINCIPAL_INVESTIGATOR
Université de Montréal, MUSEC
Locations
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Université de Montréal
Montreal, Quebec, Canada
Countries
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References
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Bradt J, Teague A. Music interventions for dental anxiety. Oral Dis. 2018 Apr;24(3):300-306. doi: 10.1111/odi.12615. Epub 2017 Jan 5.
Carter AE, Carter G, Boschen M, AlShwaimi E, George R. Pathways of fear and anxiety in dentistry: A review. World J Clin Cases. 2014 Nov 16;2(11):642-53. doi: 10.12998/wjcc.v2.i11.642.
Cohen SM, Fiske J, Newton JT. The impact of dental anxiety on daily living. Br Dent J. 2000 Oct 14;189(7):385-90. doi: 10.1038/sj.bdj.4800777.
Gordon D, Heimberg RG, Tellez M, Ismail AI. A critical review of approaches to the treatment of dental anxiety in adults. J Anxiety Disord. 2013 May;27(4):365-78. doi: 10.1016/j.janxdis.2013.04.002. Epub 2013 Apr 13.
Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12.
Kuhlmann AYR, de Rooij A, Kroese LF, van Dijk M, Hunink MGM, Jeekel J. Meta-analysis evaluating music interventions for anxiety and pain in surgery. Br J Surg. 2018 Jun;105(7):773-783. doi: 10.1002/bjs.10853. Epub 2018 Apr 17.
Mejia-Rubalcava C, Alanis-Tavira J, Mendieta-Zeron H, Sanchez-Perez L. Changes induced by music therapy to physiologic parameters in patients with dental anxiety. Complement Ther Clin Pract. 2015 Nov;21(4):282-6. doi: 10.1016/j.ctcp.2015.10.005. Epub 2015 Oct 27.
Rainville P, Bao QVH, Chretien P. Pain-related emotions modulate experimental pain perception and autonomic responses. Pain. 2005 Dec 5;118(3):306-318. doi: 10.1016/j.pain.2005.08.022. Epub 2005 Nov 14.
Roy M, Peretz I, Rainville P. Emotional valence contributes to music-induced analgesia. Pain. 2008 Jan;134(1-2):140-7. doi: 10.1016/j.pain.2007.04.003. Epub 2007 May 25.
Other Identifiers
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18-004-CERC-P
Identifier Type: -
Identifier Source: org_study_id
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