Effect of Music on Burden of Dental Implant Surgery

Personalized Musical Intervention Clinical Trial

Official title:

Effect of Personalized Musical Intervention on Burden of Care in Dental Implant Surgery: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04099264
• Other study ID #: 18-004-CERC-P
• Status: Completed
• Phase: N/A
• Start date: October 12, 2018
• Est. completion date: March 21, 2020

Study information

• Verified date: January 2022
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 21, 2020
• Est. primary completion date: December 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Personalized Musical Intervention

Intervention

Other:
• 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

Locations

Country	Name	City	State
Canada	Université de Montréal	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Montréal

Country where clinical trial is conducted

Canada, 

References & 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. Review. — View Citation

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. Review. — View Citation

Cohen SM, Fiske J, Newton JT. The impact of dental anxiety on daily living. Br Dent J. 2000 Oct 14;189(7):385-90. — View Citation

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. Review. — View Citation

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. Review. Erratum in: Lancet. 2015 — View Citation

Kühlmann 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. — View Citation

Mejía-Rubalcava C, Alanís-Tavira J, Mendieta-Zerón H, Sánchez-Pérez 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 — View Citation

Rainville P, Bao QVH, Chrétien 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. — View Citation

Roy M, Peretz I, Rainville P. Emotional valence contributes to music-induced analgesia. Pain. 2008 Jan;134(1-2):140-7. Epub 2007 May 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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