Effect of a Personalized Sound Intervention During Autogenous Gingival Grafts in Adults
Study Details
Study Description
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, 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- burden of care [immediately before surgery]
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)
- burden of care [immediately after surgery]
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)
- burden of care [2 weeks postop]
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)
Secondary Outcome Measures
- sociodemographic data [1 week before surgery]
age, sex, gender, level of education, yearly income
- participants' expectations [immediately before surgery]
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)
- participants' expectations [immediately after surgery]
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)
- participants' expectations [2 weeks postop]
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)
- Index of dental anxiety and fear [1 week before surgery]
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
- Index of dental anxiety and fear [immediately before surgery]
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
- Index of dental anxiety and fear [immediately after surgery]
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
- Index of dental anxiety and fear [2 weeks postop]
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
- State-trait anxiety inventory (Spielberg DC et al, 1977) [1 week before surgery]
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
- State-trait anxiety inventory (Spielberg DC et al, 1977) [immediately before surgery]
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
- State-trait anxiety inventory [immediately after surgery]
validated general anxiety questionnaire
- State-trait anxiety inventory (Spielberg DC et al, 1977) [2 weeks postop]
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
- Anxiety coping strategies [1 week before surgery]
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? ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
- Cafeine and medications consumption [1 week before surgery]
mean consumption per week, # taken today (coffee, tea, sodas, energy drinks, medications = analgesics, stimulants, nutrition supplements, other medications)
- Cafeine and medications consumption [immediately before surgery]
mean consumption per week, # taken today (coffee, tea, sodas, energy drinks, medications = analgesics, stimulants, nutrition supplements, other medications)
- Cafeine and medications consumption [2 weeks postop]
mean consumption per week, # taken today (coffee, tea, sodas, energy drinks, medications = analgesics, stimulants, nutrition supplements, other medications)
- Feelings at the present moment [immediately before surgery]
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)
- Feelings at the present moment [immediately after surgery]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Need a gingival graft that will not exceed 1.5 hour of surgery
-
Understand spoken and written French or English
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Has the capacity to understand procedures and follow instructions
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Consent to follow instructions
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Consent to receive either the active or control sound condition
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinique dentaire Antoine Sabeh | Montreal | Quebec | Canada | H2J 1K1 |
| 2 | Le Groupe des parodontistes | Montreal | Quebec | Canada | H3H 1R6 |
| 3 | Université de Montréal - Faculty of Dentistry - Dental clinics | Montreal | Quebec | Canada | H3T 1J4 |
Sponsors and Collaborators
- Université de Montréal
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-1146