Effect of Music on Burden of Dental Implant Surgery

Study Overview
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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.

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

Conditions
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Personalized Musical Intervention

Intervention / Treatment
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* Other: Personalized music
* Other: Audio Books


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group: Personalized music<br>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). | Other: Personalized music<br>* Patients in the intervention group will listen to personalized music from the Musicare application<br>|
| Active Comparator: Control: Audio Books<br>Control will consist of audio books. | Other: Audio Books<br>* Patients in the active comparator group will listen to audio books<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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personalized musical intervention, experimental study, dissatisfaction, anxiety, surgical pain, burden of care, pilot randomized controlled trial