Effect of Music on Burden of Dental Implant Surgery
Effect of Personalized Musical Intervention on Burden of Care in Dental Implant Surgery: A Pilot Randomized Controlled Trial
1 other identifier
interventional
24
1 country
1
Brief Summary
Personnalized music can decrease the burden of care. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2018
CompletedStudy Start
First participant enrolled
October 12, 2018
CompletedFirst Posted
Study publicly available on registry
September 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2020
CompletedJanuary 24, 2022
January 1, 2022
1.2 years
August 24, 2018
January 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Burden of dental implant surgery
Composite outcome by summing the means of the 0-10 visual analogue scales of surgical pain, state anxiety and dissatisfaction.
Measured immediately at the end of surgery
Study Arms (2)
Intervention group: Personalized music
EXPERIMENTALThis arm will receive an intervention which will be personalized music. It will be provided by Music Care application (https://www.music-care.com/fr).
Control: Audio Books
ACTIVE COMPARATORControl will consist of audio books.
Interventions
Patients in the intervention group will listen to personalized music from the Musicare application
Patients in the active comparator group will listen to audio books
Eligibility Criteria
You may qualify if:
- Patients included in the study:
- 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,
You may not qualify if:
- Patients :
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Université de Montréal
Montreal, Quebec, H3T 1J4, Canada
Related Publications (9)
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.
PMID: 27886431RESULTCarter 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.
PMID: 25405187RESULTCohen 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.
PMID: 11081950RESULTGordon 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.
PMID: 23746494RESULTHole 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.
PMID: 26277246RESULTKuhlmann 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.
PMID: 29665028RESULTMejia-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.
PMID: 26573456RESULTRainville 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.
PMID: 16289802RESULTRoy 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.
PMID: 17532141RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathalie Gosselin, PhD
Université de Montréal, MUSEC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, Neuropsychologist
Study Record Dates
First Submitted
August 24, 2018
First Posted
September 23, 2019
Study Start
October 12, 2018
Primary Completion
December 11, 2019
Study Completion
March 21, 2020
Last Updated
January 24, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share