Clinical trial NCT05632679: Effect of a Personalized Sound Intervention During Autogenous Gingival Grafts in Adults
Official title: Effects of a Personalized Sound Intervention on Anxiety, Pain, and Satisfaction During Autogenous Gingival Graft in Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Music Intervention
Gingival Graft
Anxiety
Pain
Dissatisfaction
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind randomized clinical trial
Primary purpose: TREATMENT

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).


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 outcomes:
measure: burden of care
timeFrame: immediately before surgery
measure: burden of care
timeFrame: immediately after surgery
measure: burden of care
timeFrame: 2 weeks postop
Secondary outcomes:
measure: sociodemographic data
timeFrame: 1 week before surgery
measure: participants' expectations
timeFrame: immediately before surgery
measure: participants' expectations
timeFrame: immediately after surgery
measure: participants' expectations
timeFrame: 2 weeks postop
measure: Index of dental anxiety and fear
timeFrame: 1 week before surgery
measure: Index of dental anxiety and fear
timeFrame: immediately before surgery
measure: Index of dental anxiety and fear
timeFrame: immediately after surgery
measure: Index of dental anxiety and fear
timeFrame: 2 weeks postop
measure: State-trait anxiety inventory (Spielberg DC et al, 1977)
timeFrame: 1 week before surgery
measure: State-trait anxiety inventory (Spielberg DC et al, 1977)
timeFrame: immediately before surgery
measure: State-trait anxiety inventory
timeFrame: immediately after surgery
measure: State-trait anxiety inventory (Spielberg DC et al, 1977)
timeFrame: 2 weeks postop
measure: Anxiety coping strategies
timeFrame: 1 week before surgery
measure: Cafeine and medications consumption
timeFrame: 1 week before surgery
measure: Cafeine and medications consumption
timeFrame: immediately before surgery
measure: Cafeine and medications consumption
timeFrame: 2 weeks postop
measure: Feelings at the present moment
timeFrame: immediately before surgery
measure: Feelings at the present moment
timeFrame: immediately after surgery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinique dentaire Antoine Sabeh
state: Quebec
city: Montreal
country: Canada
facility: Le Groupe des parodontistes
state: Quebec
city: Montreal
country: Canada
facility: Université de Montréal - Faculty of Dentistry - Dental clinics
state: Quebec
Study officials:
References: