Effect of a Personalized Sound Intervention During Autogenous Gingival Grafts in Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-05-01

Brief Summary

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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).

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Detailed Description

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Conditions

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Music Intervention Gingival Graft Anxiety Pain Dissatisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-blind randomized clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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personalized music intervention

Group Type EXPERIMENTAL

personalized music intervention

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

selected audio book

Intervention Type OTHER

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

standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes