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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05632679
Other study ID # 2021-1146
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date May 1, 2024

Study information

Verified date July 2023
Source Université de Montréal
Contact Robert Durand
Phone 514-343-7464
Email robert.durand@umontreal.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date May 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


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
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

Locations

Country Name City State
Canada Clinique dentaire Antoine Sabeh Montreal Quebec
Canada Le Groupe des parodontistes Montreal Quebec
Canada Université de Montréal - Faculty of Dentistry - Dental clinics Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 sociodemographic data age, sex, gender, level of education, yearly income 1 week before surgery
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary State-trait anxiety inventory validated general anxiety questionnaire immediately after surgery
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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