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

Primary Purpose

Music Intervention, Gingival Graft, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
personalized music intervention
selected audio book
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Music Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinique dentaire Antoine SabehRecruiting
  • Le Groupe des parodontistesRecruiting
  • Université de Montréal - Faculty of Dentistry - Dental clinicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

personalized music intervention

selected audio book

standard care

Arm Description

Outcomes

Primary Outcome Measures

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)
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)
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)

Secondary Outcome Measures

sociodemographic data
age, sex, gender, level of education, yearly income
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)
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)
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)
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
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
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
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
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
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
State-trait anxiety inventory
validated general anxiety questionnaire
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
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? ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Cafeine and medications consumption
mean consumption per week, # taken today (coffee, tea, sodas, energy drinks, medications = analgesics, stimulants, nutrition supplements, other medications)
Cafeine and medications consumption
mean consumption per week, # taken today (coffee, tea, sodas, energy drinks, medications = analgesics, stimulants, nutrition supplements, other medications)
Cafeine and medications consumption
mean consumption per week, # taken today (coffee, tea, sodas, energy drinks, medications = analgesics, stimulants, nutrition supplements, other medications)
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)
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)

Full Information

First Posted
September 5, 2022
Last Updated
July 1, 2023
Sponsor
Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT05632679
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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, 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Music Intervention, Gingival Graft, Anxiety, Pain, Dissatisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blind randomized clinical trial
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
personalized music intervention
Arm Type
Experimental
Arm Title
selected audio book
Arm Type
Active Comparator
Arm Title
standard care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
personalized music intervention
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
selected audio book
Intervention Description
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
Primary Outcome Measure Information:
Title
burden of care
Description
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)
Time Frame
immediately before surgery
Title
burden of care
Description
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)
Time Frame
immediately after surgery
Title
burden of care
Description
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)
Time Frame
2 weeks postop
Secondary Outcome Measure Information:
Title
sociodemographic data
Description
age, sex, gender, level of education, yearly income
Time Frame
1 week before surgery
Title
participants' expectations
Description
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)
Time Frame
immediately before surgery
Title
participants' expectations
Description
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)
Time Frame
immediately after surgery
Title
participants' expectations
Description
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)
Time Frame
2 weeks postop
Title
Index of dental anxiety and fear
Description
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
Time Frame
1 week before surgery
Title
Index of dental anxiety and fear
Description
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
Time Frame
immediately before surgery
Title
Index of dental anxiety and fear
Description
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
Time Frame
immediately after surgery
Title
Index of dental anxiety and fear
Description
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
Time Frame
2 weeks postop
Title
State-trait anxiety inventory (Spielberg DC et al, 1977)
Description
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
Time Frame
1 week before surgery
Title
State-trait anxiety inventory (Spielberg DC et al, 1977)
Description
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
Time Frame
immediately before surgery
Title
State-trait anxiety inventory
Description
validated general anxiety questionnaire
Time Frame
immediately after surgery
Title
State-trait anxiety inventory (Spielberg DC et al, 1977)
Description
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
Time Frame
2 weeks postop
Title
Anxiety coping strategies
Description
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? ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Time Frame
1 week before surgery
Title
Cafeine and medications consumption
Description
mean consumption per week, # taken today (coffee, tea, sodas, energy drinks, medications = analgesics, stimulants, nutrition supplements, other medications)
Time Frame
1 week before surgery
Title
Cafeine and medications consumption
Description
mean consumption per week, # taken today (coffee, tea, sodas, energy drinks, medications = analgesics, stimulants, nutrition supplements, other medications)
Time Frame
immediately before surgery
Title
Cafeine and medications consumption
Description
mean consumption per week, # taken today (coffee, tea, sodas, energy drinks, medications = analgesics, stimulants, nutrition supplements, other medications)
Time Frame
2 weeks postop
Title
Feelings at the present moment
Description
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)
Time Frame
immediately before surgery
Title
Feelings at the present moment
Description
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)
Time Frame
immediately after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Durand
Phone
514-343-7464
Email
robert.durand@umontreal.ca
Facility Information:
Facility Name
Clinique dentaire Antoine Sabeh
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2J 1K1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
René Voyer
Phone
514-343-7464
Email
rene.voyer@umontreal.ca
Facility Name
Le Groupe des parodontistes
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1R6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Durand
Phone
514-343-7464
Email
robert.durand@umontreal.ca
Facility Name
Université de Montréal - Faculty of Dentistry - Dental clinics
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1J4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Durand, DMD, MS
Phone
514-343-7464
Email
robert.durand@umontreal.ca
First Name & Middle Initial & Last Name & Degree
Rene Voyer, BS, DMD, MS
Phone
514-343-5926
Email
rene.voyer@umontreal.ca
First Name & Middle Initial & Last Name & Degree
Robert Durand, DMD, MS
First Name & Middle Initial & Last Name & Degree
Rene Voyer, BS, DMD, MS
First Name & Middle Initial & Last Name & Degree
Ryma Kabir, DMD, MS

12. IPD Sharing Statement

Plan to Share IPD
No

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

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