Effect of Music on Burden of Dental Implant Surgery

January 21, 2022 updated by: Nathalie Gosselin, Université de Montréal

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, h3t 1j4
        • Université de Montréal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured immediately at the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Montréal

Investigators

  • Principal Investigator: Nathalie Gosselin, PhD, Université de Montréal, MUSEC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2018

Primary Completion (Actual)

December 11, 2019

Study Completion (Actual)

March 21, 2020

Study Registration Dates

First Submitted

August 24, 2018

First Submitted That Met QC Criteria

September 19, 2019

First Posted (Actual)

September 23, 2019

Study Record Updates

Last Update Posted (Actual)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 21, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18-004-CERC-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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