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

NCT05632679 | Unknown

• 1 other identifier: 2021-1146
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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).

Conditions

Music Intervention; Gingival Graft; Anxiety; Pain; Dissatisfaction

Outcome Measures

Primary Outcomes (3)

• burden of care

  anxiety, pain and satisfaction measured using VAS scales (0 - 10mm; 0= no anxiety, no pain, no satisfaction, and 10= maximum anxiety, worst pain imaginable, maximum satisfaction)

  immediately before surgery

• burden of care

  anxiety, pain and satisfaction measured using VAS scales (0 - 10mm; 0= no anxiety, no pain, no satisfaction, and 10= maximum anxiety, worst pain imaginable, maximum satisfaction)

  immediately after surgery

• burden of care

  anxiety, pain and satisfaction measured using VAS scales (0 - 10mm; 0= no anxiety, no pain, no satisfaction, and 10= maximum anxiety, worst pain imaginable, maximum satisfaction)

  2 weeks postop

Secondary Outcomes (18)

• sociodemographic data

  1 week before surgery

• participants' expectations

  immediately before surgery

• participants' expectations

  immediately after surgery

• participants' expectations

  2 weeks postop

• Index of dental anxiety and fear

  1 week before surgery

Study Arms (3)

personalized music intervention

EXPERIMENTAL

Other: personalized music intervention

selected audio book

ACTIVE COMPARATOR

Other: selected audio book

standard care

NO INTERVENTION

Interventions

personalized music intervention 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

personalized music intervention

selected audio book 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

selected audio book

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Montréal: lead

Study Sites (3)

Clinique dentaire Antoine Sabeh

Montreal, Quebec, H2J 1K1, Canada

RECRUITING

Le Groupe des parodontistes

Montreal, Quebec, H3H 1R6, Canada

RECRUITING

Université de Montréal - Faculty of Dentistry - Dental clinics

Montreal, Quebec, H3T 1J4, Canada

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Robert Durand

CONTACT

514-343-7464; robert.durand@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single-blind randomized clinical trial

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: November 30, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)