Music InterventionNCT05632679
Effect of a Personalized Sound Intervention During Autogenous Gingival Grafts in Adults
A study testing personalized music intervention and selected audio book in people with Music Intervention and Gingival Graft, run by Université de Montréal at 3 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Music Intervention, Gingival Graft, Anxiety
- What is being tested?
- personalized music intervention and selected audio book
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesCanada
- Study dates
- 1 May 2022to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 3 recruiting
- Recruiting
Clinique dentaire Antoine Sabeh
Montreal, Quebec, H2J 1K1
René Voyer, 514-343-7464, rene.voyer@umontreal.ca
- Recruiting
Le Groupe des parodontistes
Montreal, Quebec, H3H 1R6
Robert Durand, 514-343-7464, robert.durand@umontreal.ca
- Recruiting
Université de Montréal - Faculty of Dentistry - Dental clinics
Montreal, Quebec, H3T 1J4
Robert Durand, DMD, MS, 514-343-7464, robert.durand@umontreal.ca
Rene Voyer, BS, DMD, MS, 514-343-5926, rene.voyer@umontreal.ca
About this study
Official title: 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).
- Conditions
- Music Intervention, Gingival Graft, Anxiety, Pain, Dissatisfaction
- Being tested
- personalized music intervention, selected audio book
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized music interventionOther
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 bookOther
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
| Study group | Role | What they receive |
|---|---|---|
| personalized music intervention | Experimental | Not described Receives: Other: personalized music intervention |
| selected audio book | Active comparator | Not described Receives: Other: selected audio book |
| standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 2 weeks postop
Secondary outcomes (18)
sociodemographic data
age, sex, gender, level of education, yearly income
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: immediately before surgery
State-trait anxiety inventory
validated general anxiety questionnaire
Measured: 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
Measured: 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? ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start1 May 2022
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Durand, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632679
- Sponsor's protocol ID
- 2021-1146
- Status last verified
- Jul 2023
- First submitted
- 5 Sep 2022
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Personalized Sound Intervention on Anxiety, Pain, and Satisfaction During Autogenous Gingival Graft in Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05632679
- Acronym / sponsor ID
- 2021-1146
- Conditions
- Music Intervention, Gingival Graft, Anxiety, Pain, Dissatisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Single-blind randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| personalized music intervention | Experimental | Other: personalized music intervention |
| selected audio book | Active comparator | Other: selected audio book |
| standard care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| personalized music interventionparticipants 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 | Other | personalized music intervention |
| selected audio bookparticipants who are randomly selected to this group will choose one audio book they prefer among the available selection of audio books on the tablet | Other | selected audio book |
Primary outcome
burden of care
Time frame: 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
Time frame: 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
Time frame: 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)
18 secondary outcomes
sociodemographic data
Time frame: 1 week before surgery
participants' expectations
Time frame: immediately before surgery
participants' expectations
Time frame: immediately after surgery
participants' expectations
Time frame: 2 weeks postop
Index of dental anxiety and fear
Time frame: 1 week before surgery
Index of dental anxiety and fear
Time frame: immediately before surgery
Index of dental anxiety and fear
Time frame: immediately after surgery
Index of dental anxiety and fear
Time frame: 2 weeks postop
State-trait anxiety inventory (Spielberg DC et al, 1977)
Time frame: 1 week before surgery
State-trait anxiety inventory (Spielberg DC et al, 1977)
Time frame: immediately before surgery
State-trait anxiety inventory
Time frame: immediately after surgery
State-trait anxiety inventory (Spielberg DC et al, 1977)
Time frame: 2 weeks postop
Anxiety coping strategies
Time frame: 1 week before surgery
Cafeine and medications consumption
Time frame: 1 week before surgery
Cafeine and medications consumption
Time frame: immediately before surgery
Cafeine and medications consumption
Time frame: 2 weeks postop
Feelings at the present moment
Time frame: immediately before surgery
Feelings at the present moment
Time frame: immediately after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Music Intervention
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Preoperative Music Intervention for Anxiety in Hip and Knee Arthroplasty
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Perioperative Meditation Music Intervention in Patients With Type 2 Diabetes Undergoing Elective Surgery
Diabetes Type 2
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Musical Intervention for Dental Anxiety
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Not yet recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalized music intervention and selected audio book in people with Music Intervention and Gingival Graft, run by Université de Montréal at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Durand (514-343-7464, robert.durand@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
burden of care (time frame: immediately before surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.