Recruiting

Personalized Sound Intervention

Sponsor:

Université de Montréal

Code:

NCT05632679

Conditions

Music Intervention

Gingival Graft

Anxiety

Pain

Dissatisfaction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

personalized music intervention

selected audio book

Study Details

Brief summary:

Anxiety feeds the avoidance of dental treatments, leading to the neglect of general oral health. This avoidance is often amplified by the fear of potential pain and dissatisfaction after a dental appointment. A music listening intervention could be beneficial to reduce anxiety, pain and dissatisfaction. This intervention has the advantage to be non-invasive, cheap, and easy to implement in clinical settings. The objective of this study is to explore the effects of a personalised musical intervention on anxiety, pain and dissatisfaction associated with an autogenous gingival graft in comparison to the use of an audiobook (control). In this regard, three groups of patients will receive the gingival graft along with the personalized music intervention (n=20), an audiobook (n=20) or standard care (n=20). Participants will be distributed randomly between conditions in a single blind design (surgeons will be unaware of the condition). However, since the third standard care control group was added as of 07-01-2023, all recruited participants will be enrolled in the standard care control group (non-randomized). Self-reported measures of anxiety, pain, and dissatisfaction will be taken at different times (baseline, preoperative, postoperative, and follow-up).

Conditions

Music Intervention

Gingival Graft

Anxiety

Pain

Dissatisfaction

Study ID

NCT05632679

Start date

May 1, 2022

Status verified date

Jul, 2023

Completion date

May 1, 2024

Anticipated

Primary completion date

May 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Need a gingival graft that will not exceed 1.5 hour of surgery
  • Understand spoken and written French or English
  • Has the capacity to understand procedures and follow instructions
  • Consent to follow instructions
  • Consent to receive either the active or control sound condition
  • Being 18 years or older

Exclusion Criteria:

  • Do not need a gingival graft
  • Need a gingival graft that will last more than 1.5 hour of surgery
  • Mental health or neurological disorders
  • Auditory disorder
  • Allergy or intolerance to NSAIDS

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: personalized music intervention

active comparator: selected audio book

no intervention: standard care

Interventions

personalized music intervention

participants who are randomly selected to this group will choose three set of music they prefer among the available selection of instrumental music in the application

selected audio book

participants who are randomly selected to this group will choose one audio book they prefer among the available selection of audio books on the tablet

Primary outcome measure

  • burden of care [ Time Frame: immediately before surgery ]
  • burden of care [ Time Frame: immediately after surgery ]
  • burden of care [ Time Frame: 2 weeks postop ]

Central Contacts and Locations

Central contacts

Locations

Clinique dentaire Antoine Sabeh

Recruiting

Montreal, Quebec, Canada, H2J 1K1

Contacts

Le Groupe des parodontistes

Recruiting

Montreal, Quebec, Canada, H3H 1R6

Contacts

Université de Montréal - Faculty of Dentistry - Dental clinics

Recruiting

Montreal, Quebec, Canada, H3T 1J4

Contacts

Principal Investigator:

Robert Durand, DMD, MS

More Information

Sponsor

Université de Montréal

Last update posted

Jul 5, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Montréal on 2023-07-05.