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NCT05632679
Effect of a Personalized Sound Intervention During Autogenous Gingival Grafts in Adults
Conditions: Music Intervention, Gingival Graft, Anxiety, Pain, Dissatisfaction
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 50
Sponsor: Université de Montréal
Location: Canada
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, two groups of patients will receive the gingival graft along with the personalized music intervention (n=8) or an audiobook (n=5).
Participants will be distributed randomly between conditions in a single blind design (surgeons will be unaware of the condition).
Self-reported measures of anxiety, pain, and dissatisfaction will be taken at different times (baseline, preoperative, postoperative, and follow-up).
Eligibility Criteria
Inclusion Criteria:Need a gingival graft that will not exceed 1.5 hour of surgeryUnderstand spoken and written French or EnglishHas the capacity to understand procedures and follow instructionsConsent to follow instructionsConsent to receive either the active or control sound conditionBeing 18 years or olderExclusion Criteria:Do not need a gingival graftNeed a gingival graft that will last more than 1.5 hour of surgeryMental health or neurological disordersAuditory disorderAllergy or intolerance to NSAIDS
Source: ClinicalTrials.gov (NCT05632679). StuddyBuddy aggregates publicly available trial information.