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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Pain; Anxiety; Music Intervention; Gingival Graft; Dissatisfaction
• Intervention / Treatment: Other: personalized music intervention; Other: selected audio book

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Durand; Phone Number: 514-343-7464; Email: robert.durand@umontreal.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2J 1K1
      • Recruiting
      • Clinique dentaire Antoine Sabeh
      • Contact: René Voyer; Phone Number: 514-343-7464; Email: rene.voyer@umontreal.ca
    • Montreal, Quebec, Canada, H3H 1R6
      • Recruiting
      • Le Groupe des parodontistes
      • Contact: Robert Durand; Phone Number: 514-343-7464; Email: robert.durand@umontreal.ca
    • Montreal, Quebec, Canada, H3T 1J4
      • Recruiting
      • Université de Montréal - Faculty of Dentistry - Dental clinics
      • Contact: Robert Durand, DMD, MS; Phone Number: 514-343-7464; Email: robert.durand@umontreal.ca
      • Contact: Rene Voyer, BS, DMD, MS; Phone Number: 514-343-5926; Email: rene.voyer@umontreal.ca
      • Principal Investigator: Robert Durand, DMD, MS
      • Sub-Investigator: Rene Voyer, BS, DMD, MS
      • Sub-Investigator: Ryma Kabir, DMD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard care
Experimental: personalized music intervention	Other: personalized music intervention; 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
Active Comparator: selected audio book	Other: selected audio book; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
sociodemographic data	age, sex, gender, level of education, yearly income	1 week before surgery
participants' expectations	expected pain and complications, expected and felt efficiency of the sound condition (VAS scales) (0 - 10mm; 0= no pain, no complications, no efficiency, and 10= worst pain imaginable, maximum complication, maximum efficiency)	immediately before surgery
participants' expectations	expected pain and complications, expected and felt efficiency of the sound condition (VAS scales) (0 - 10mm; 0= no pain, no complications, no efficiency, and 10= worst pain imaginable, maximum complication, maximum efficiency)	immediately after surgery
participants' expectations	expected pain and complications, expected and felt efficiency of the sound condition (VAS scales) (0 - 10mm; 0= no pain, no complications, no efficiency, and 10= worst pain imaginable, maximum complication, maximum efficiency)	2 weeks postop
Index of dental anxiety and fear	A.1. To what extent are you anxious about the following things when you go to the dentist? Not at all A little Somewhat Moderately Very much; Painful or uncomfortable procedures; Feeling embarrassed or ashamed; Not being in control of what is happening; Feeling sick, queasy, or disgusted; Numbness caused by the anesthetic; Not knowing what the dentist is going to do; The cost of dental treatment; Needles or injections; Gagging or choking; Having an unsympathetic or unkind dentist A.2 On the following scale, how would you rate your level of anxiety at the present time? No anxiety Maximum anxiety A.3.1 On the following scale, what level of pain do you experience right now? Worst pain No pain imaginable A.3.2 On the following scale, what level of pain do you expect to experience during surgery? Worst pain No pain imaginable	1 week before surgery
Index of dental anxiety and fear	A.1. To what extent are you anxious about the following things when you go to the dentist? Not at all A little Somewhat Moderately Very much; Painful or uncomfortable procedures; Feeling embarrassed or ashamed; Not being in control of what is happening; Feeling sick, queasy, or disgusted; Numbness caused by the anesthetic; Not knowing what the dentist is going to do; The cost of dental treatment; Needles or injections; Gagging or choking; Having an unsympathetic or unkind dentist A.2 On the following VAS 10-mm scale, how would you rate your level of anxiety at the present time? No anxiety Maximum anxiety A.3.1 On the following VAS 10-mm scale, what level of pain do you experience right now? Worst pain No pain imaginable A.3.2 On the following VAS 10-mm scale, what level of pain do you expect to experience during surgery? Worst pain No pain imaginable	immediately before surgery
Index of dental anxiety and fear	A.1. To what extent are you anxious about the following things when you go to the dentist? Not at all A little Somewhat Moderately Very much; Painful or uncomfortable procedures; Feeling embarrassed or ashamed; Not being in control of what is happening; Feeling sick, queasy, or disgusted; Numbness caused by the anesthetic; Not knowing what the dentist is going to do; The cost of dental treatment; Needles or injections; Gagging or choking; Having an unsympathetic or unkind dentist A.2 On the following VAS 10-mm scale, how would you rate your level of anxiety at the present time? No anxiety Maximum anxiety A.3.1 On the following VAS 10-mm scale, what level of pain do you experience right now? Worst pain No pain imaginable A.3.2 On the following VAS 10-mm scale, what level of pain do you expect to experience during surgery? Worst pain No pain imaginable	immediately after surgery
Index of dental anxiety and fear	A.1. To what extent are you anxious about the following things when you go to the dentist? Not at all A little Somewhat Moderately Very much; Painful or uncomfortable procedures; Feeling embarrassed or ashamed; Not being in control of what is happening; Feeling sick, queasy, or disgusted; Numbness caused by the anesthetic; Not knowing what the dentist is going to do; The cost of dental treatment; Needles or injections; Gagging or choking; Having an unsympathetic or unkind dentist A.2 On the following VAS 10-mm scale, how would you rate your level of anxiety at the present time? No anxiety Maximum anxiety A.3.1 On the following VAS 10-mm scale, what level of pain do you experience right now? Worst pain No pain imaginable A.3.2 On the following VAS 10-mm scale, what level of pain do you expect to experience during surgery? Worst pain No pain imaginable	2 weeks postop
State-trait anxiety inventory (Spielberg DC et al, 1977)	Do not spend too much time on any one statement but give the answer which seems to describe your present feelings best. Choice of selection: not at all (1), somewhat (2), moderately so (3), very much (4) Right now: I feel calm; I feel secure; I am tense; I feel strained; I feel at ease; I feel upset; I am presently worrying over possible misfortunes; I feel satisfied; I feel frightened; I feel comfortable; I feel self-confident; I feel nervous; I am jittery; I feel indecisive,; I am relaxed; I feel content,; I am worried,; I feel confused,; I feel steady; I feel pleasant	1 week before surgery
State-trait anxiety inventory (Spielberg DC et al, 1977)	Do not spend too much time on any one statement but give the answer which seems to describe your present feelings best. Choice of selection: not at all (1), somewhat (2), moderately so (3), very much (4) Right now: I feel calm; I feel secure; I am tense; I feel strained; I feel at ease; I feel upset; I am presently worrying over possible misfortunes; I feel satisfied; I feel frightened; I feel comfortable; I feel self-confident; I feel nervous; I am jittery; I feel indecisive,; I am relaxed; I feel content,; I am worried,; I feel confused,; I feel steady; I feel pleasant	immediately before surgery
State-trait anxiety inventory	validated general anxiety questionnaire	immediately after surgery
State-trait anxiety inventory (Spielberg DC et al, 1977)	Do not spend too much time on any one statement but give the answer which seems to describe your present feelings best. Choice of selection: not at all (1), somewhat (2), moderately so (3), very much (4) Right now: I feel calm; I feel secure; I am tense; I feel strained; I feel at ease; I feel upset; I am presently worrying over possible misfortunes; I feel satisfied; I feel frightened; I feel comfortable; I feel self-confident; I feel nervous; I am jittery; I feel indecisive,; I am relaxed; I feel content,; I am worried,; I feel confused,; I feel steady; I feel pleasant	2 weeks postop
Anxiety coping strategies	Q.1: Have you ever used strategies to manage your anxiety at the dentist? __Yes ___No 1. If yes, can you indicate them? ___Do breathing exercises ___Meditate ___Playing sports; Talking, writing, or texting to a friend ___Reading ___Listening to music___Watching a movie; Playing a game ___Other: .......................................................................................................................... Q.2: Did you already have a gingival graft in the past? ___Yes ___No 1 If yes, in your opinion, how did the intervention go? Really bad___ Really good ___ C2.1.1 Why did you choose this answer? ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………	1 week before surgery
Cafeine and medications consumption	mean consumption per week, # taken today (coffee, tea, sodas, energy drinks, medications = analgesics, stimulants, nutrition supplements, other medications)	1 week before surgery
Cafeine and medications consumption	mean consumption per week, # taken today (coffee, tea, sodas, energy drinks, medications = analgesics, stimulants, nutrition supplements, other medications)	immediately before surgery
Cafeine and medications consumption	mean consumption per week, # taken today (coffee, tea, sodas, energy drinks, medications = analgesics, stimulants, nutrition supplements, other medications)	2 weeks postop
Feelings at the present moment	valence, arousal, dominance using numerical and illustrated scales (A to I; A = happy/elated, excited/involved, being controlled/taken care of; I = unhappy/sad, calm/bored, being in control/on top of things)	immediately before surgery
Feelings at the present moment	valence, arousal, dominance using numerical and illustrated scales (A to I; A = happy/elated, excited/involved, being controlled/taken care of; I = unhappy/sad, calm/bored, being in control/on top of things)	immediately after surgery

Collaborators and Investigators

• Sponsor: Université de Montréal

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: September 5, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 1, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2021-1146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No