Clinical trial NCT04099264: Effect of Music on Burden of Dental Implant Surgery
Official title: Effect of Personalized Musical Intervention on Burden of Care in Dental Implant Surgery: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Personalized Musical Intervention
Keywords: personalized musical intervention
experimental study
dissatisfaction
anxiety
surgical pain
burden of care
pilot randomized controlled trial
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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:

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.

Primary outcomes:
measure: Burden of dental implant surgery
timeFrame: Measured immediately at the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Université de Montréal
state: Quebec
Study officials:
affiliation: Université de Montréal, MUSEC
name: Nathalie Gosselin, PhD
role: PRINCIPAL_INVESTIGATOR
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