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Clinical Trials/NCT04099264
NCT04099264
Completed
Not Applicable

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

Université de Montréal1 site in 1 country24 target enrollmentOctober 12, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Personalized Musical Intervention
Sponsor
Université de Montréal
Enrollment
24
Locations
1
Primary Endpoint
Burden of dental implant surgery
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 12, 2018
End Date
March 21, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nathalie Gosselin

PhD, Neuropsychologist

Université de Montréal

Eligibility Criteria

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

  • 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.

Outcomes

Primary Outcomes

Burden of dental implant surgery

Time Frame: Measured immediately at the end of surgery

Composite outcome by summing the means of the 0-10 visual analogue scales of surgical pain, state anxiety and dissatisfaction.

Study Sites (1)

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