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

ClinicalTrials.gov ID

NCT05632679

Lead Sponsor

Université de MontréalOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

50Estimated

Last Update Posted

Jul 5, 2023Actual

Start Date

May 1, 2022Actual

Primary Completion Date

May 1, 2024Estimated

Completion Date

May 1, 2024Estimated

Official Title

Effects of a Personalized Sound Intervention on Anxiety, Pain, and Satisfaction During Autogenous Gingival Graft in Adults: A Randomized Controlled Trial

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).

• Music Intervention
• Gingival Graft
• Anxiety
• Pain
• Dissatisfaction

• personalized music intervention
• selected audio book

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

Université de MontréalOTHER

robert.durand@umontreal.ca514-343-7464

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