Effect of Music on Burden of Dental Implant Surgery

NCT ID: NCT04099264

Last Updated: 2022-01-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-12

Study Completion Date

2020-03-21

Brief Summary

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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.

Detailed Description

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Conditions

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Personalized Musical Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

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).

Group Type EXPERIMENTAL

Personalized music

Intervention Type OTHER

Patients in the intervention group will listen to personalized music from the Musicare application

Control: Audio Books

Control will consist of audio books.

Group Type ACTIVE_COMPARATOR

Audio Books

Intervention Type OTHER

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

Intervention Type OTHER

Audio Books

Patients in the active comparator group will listen to audio books

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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,

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université de Montréal

OTHER

Sponsor Role lead

Responsible Party

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Nathalie Gosselin

PhD, Neuropsychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Canada

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.

Reference Type RESULT
PMID: 27886431 (View on PubMed)

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.

Reference Type RESULT
PMID: 25405187 (View on PubMed)

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.

Reference Type RESULT
PMID: 11081950 (View on PubMed)

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.

Reference Type RESULT
PMID: 23746494 (View on PubMed)

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.

Reference Type RESULT
PMID: 26277246 (View on PubMed)

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.

Reference Type RESULT
PMID: 29665028 (View on PubMed)

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.

Reference Type RESULT
PMID: 26573456 (View on PubMed)

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.

Reference Type RESULT
PMID: 16289802 (View on PubMed)

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.

Reference Type RESULT
PMID: 17532141 (View on PubMed)

Other Identifiers

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18-004-CERC-P

Identifier Type: -

Identifier Source: org_study_id

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