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

July 1, 2023 updated by: Robert Durand, Université de Montréal

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2J 1K1
        • Recruiting
        • Clinique dentaire Antoine Sabeh
        • Contact:
      • Montreal, Quebec, Canada, H3H 1R6
      • Montreal, Quebec, Canada, H3T 1J4
        • Recruiting
        • Université de Montréal - Faculty of Dentistry - Dental clinics
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert Durand, DMD, MS
        • Sub-Investigator:
          • Rene Voyer, BS, DMD, MS
        • Sub-Investigator:
          • Ryma Kabir, DMD, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: standard care
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
immediately before surgery
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)
immediately after surgery
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)
2 weeks postop

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
sociodemographic data
Time Frame: 1 week before surgery
age, sex, gender, level of education, yearly income
1 week before surgery
participants' expectations
Time Frame: 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)
immediately before surgery
participants' expectations
Time Frame: 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)
immediately after surgery
participants' expectations
Time Frame: 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)
2 weeks postop
Index of dental anxiety and fear
Time Frame: 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

  1. Painful or uncomfortable procedures
  2. Feeling embarrassed or ashamed
  3. Not being in control of what is happening
  4. Feeling sick, queasy, or disgusted
  5. Numbness caused by the anesthetic
  6. Not knowing what the dentist is going to do
  7. The cost of dental treatment
  8. Needles or injections
  9. Gagging or choking
  10. 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
Time Frame: 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

  1. Painful or uncomfortable procedures
  2. Feeling embarrassed or ashamed
  3. Not being in control of what is happening
  4. Feeling sick, queasy, or disgusted
  5. Numbness caused by the anesthetic
  6. Not knowing what the dentist is going to do
  7. The cost of dental treatment
  8. Needles or injections
  9. Gagging or choking
  10. 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
Time Frame: 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

  1. Painful or uncomfortable procedures
  2. Feeling embarrassed or ashamed
  3. Not being in control of what is happening
  4. Feeling sick, queasy, or disgusted
  5. Numbness caused by the anesthetic
  6. Not knowing what the dentist is going to do
  7. The cost of dental treatment
  8. Needles or injections
  9. Gagging or choking
  10. 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
Time Frame: 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

  1. Painful or uncomfortable procedures
  2. Feeling embarrassed or ashamed
  3. Not being in control of what is happening
  4. Feeling sick, queasy, or disgusted
  5. Numbness caused by the anesthetic
  6. Not knowing what the dentist is going to do
  7. The cost of dental treatment
  8. Needles or injections
  9. Gagging or choking
  10. 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)
Time Frame: 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:

  1. I feel calm
  2. I feel secure
  3. I am tense
  4. I feel strained
  5. I feel at ease
  6. I feel upset
  7. I am presently worrying over possible misfortunes
  8. I feel satisfied
  9. I feel frightened
  10. I feel comfortable
  11. I feel self-confident
  12. I feel nervous
  13. I am jittery
  14. I feel indecisive,
  15. I am relaxed
  16. I feel content,
  17. I am worried,
  18. I feel confused,
  19. I feel steady
  20. I feel pleasant
1 week before surgery
State-trait anxiety inventory (Spielberg DC et al, 1977)
Time Frame: 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:

  1. I feel calm
  2. I feel secure
  3. I am tense
  4. I feel strained
  5. I feel at ease
  6. I feel upset
  7. I am presently worrying over possible misfortunes
  8. I feel satisfied
  9. I feel frightened
  10. I feel comfortable
  11. I feel self-confident
  12. I feel nervous
  13. I am jittery
  14. I feel indecisive,
  15. I am relaxed
  16. I feel content,
  17. I am worried,
  18. I feel confused,
  19. I feel steady
  20. I feel pleasant
immediately before surgery
State-trait anxiety inventory
Time Frame: immediately after surgery
validated general anxiety questionnaire
immediately after surgery
State-trait anxiety inventory (Spielberg DC et al, 1977)
Time Frame: 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:

  1. I feel calm
  2. I feel secure
  3. I am tense
  4. I feel strained
  5. I feel at ease
  6. I feel upset
  7. I am presently worrying over possible misfortunes
  8. I feel satisfied
  9. I feel frightened
  10. I feel comfortable
  11. I feel self-confident
  12. I feel nervous
  13. I am jittery
  14. I feel indecisive,
  15. I am relaxed
  16. I feel content,
  17. I am worried,
  18. I feel confused,
  19. I feel steady
  20. I feel pleasant
2 weeks postop
Anxiety coping strategies
Time Frame: 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? ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
1 week before surgery
Cafeine and medications consumption
Time Frame: 1 week before surgery
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
Time Frame: immediately before surgery
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
Time Frame: 2 weeks postop
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
Time Frame: 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)
immediately before surgery
Feelings at the present moment
Time Frame: 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)
immediately after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université de Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021-1146

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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