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

Study Overview
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Brief Summary
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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).

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

Conditions
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Music Intervention, Gingival Graft, Anxiety, Pain, Dissatisfaction

Intervention / Treatment
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* Other: personalized music intervention
* Other: selected audio book


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-blind randomized clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: personalized music intervention<br> | Other: personalized music intervention<br>* 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<br>|
| Active Comparator: selected audio book<br> | Other: selected audio book<br>* 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<br>|
| No Intervention: standard care<br> | |

What is the study measuring?
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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 |