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

Université de Montréal

Status: Enrolling

Conditions: Dissatisfaction; Gingival Graft; Anxiety; Music Intervention; Pain

Treatments: Other: personalized music intervention; Other: selected audio book

Study type: Interventional

Funder types: Other

Identifiers

NCT05632679

2021-1146

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 3 patient groups

personalized music intervention

Experimental group

Treatment:

Other: personalized music intervention

selected audio book

Active Comparator group

Treatment:

Other: selected audio book

standard care

No Intervention group