## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** 2021-1146
#### Organization
**Class:** OTHER
**Full Name:** Université de Montréal
### Status Module
#### Completion Date
**Date:** 2024-05-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-07-05

**Type:** ACTUAL

**Last Update Submit Date:** 2023-07-01

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-05-01

**Type:** ACTUAL

**Status Verified Date:** 2023-07

#### Study First Post Date
**Date:** 2022-11-30
**Type:** ACTUAL
**Study First Submit Date:** 2022-09-05
**Study First Submit QC Date:** 2022-11-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Université de Montréal

#### Responsible Party

**Investigator Affiliation:** Université de Montréal

**Investigator Full Name:** Robert Durand

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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).

### Conditions Module

**Conditions:**

- Music Intervention

- Gingival Graft

- Anxiety

- Pain

- Dissatisfaction

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Single-blind randomized clinical trial

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: personalized music intervention

**Label:** personalized music intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Other: selected audio book

**Label:** selected audio book

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Label:** standard care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- personalized music 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

**Name:** personalized music intervention

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- selected audio book

**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

**Name:** selected audio book

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**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)

**Measure:** burden of care

**Time Frame:** immediately before surgery

**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)

**Measure:** burden of care

**Time Frame:** immediately after surgery

**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)

**Measure:** burden of care

**Time Frame:** 2 weeks postop

#### Secondary Outcomes

**Description:** age, sex, gender, level of education, yearly income

**Measure:** sociodemographic data

**Time Frame:** 1 week before surgery

**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)

**Measure:** participants' expectations

**Time Frame:** immediately before surgery

**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)

**Measure:** participants' expectations

**Time Frame:** immediately after surgery

**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)

**Measure:** participants' expectations

**Time Frame:** 2 weeks postop

**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

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

**Measure:** Index of dental anxiety and fear

**Time Frame:** 1 week before surgery

**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

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

**Measure:** Index of dental anxiety and fear

**Time Frame:** immediately before surgery

**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

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

**Measure:** Index of dental anxiety and fear

**Time Frame:** immediately after surgery

**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

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

**Measure:** Index of dental anxiety and fear

**Time Frame:** 2 weeks postop

**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:

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

**Measure:** State-trait anxiety inventory (Spielberg DC et al, 1977)

**Time Frame:** 1 week before surgery

**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:

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

**Measure:** State-trait anxiety inventory (Spielberg DC et al, 1977)

**Time Frame:** immediately before surgery

**Description:** validated general anxiety questionnaire

**Measure:** State-trait anxiety inventory

**Time Frame:** immediately after surgery

**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:

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

**Measure:** State-trait anxiety inventory (Spielberg DC et al, 1977)

**Time Frame:** 2 weeks postop

**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? .....................................................................................................................................................................................................................................................................................................................................................................................................................

**Measure:** Anxiety coping strategies

**Time Frame:** 1 week before surgery

**Description:** mean consumption per week, # taken today (coffee, tea, sodas, energy drinks, medications = analgesics, stimulants, nutrition supplements, other medications)

**Measure:** Cafeine and medications consumption

**Time Frame:** 1 week before surgery

**Description:** mean consumption per week, # taken today (coffee, tea, sodas, energy drinks, medications = analgesics, stimulants, nutrition supplements, other medications)

**Measure:** Cafeine and medications consumption

**Time Frame:** immediately before surgery

**Description:** mean consumption per week, # taken today (coffee, tea, sodas, energy drinks, medications = analgesics, stimulants, nutrition supplements, other medications)

**Measure:** Cafeine and medications consumption

**Time Frame:** 2 weeks postop

**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)

**Measure:** Feelings at the present moment

**Time Frame:** immediately before surgery

**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)

**Measure:** Feelings at the present moment

**Time Frame:** immediately after surgery

### Eligibility Module

**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

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** robert.durand@umontreal.ca

**Name:** Robert Durand

**Phone:** 514-343-7464

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Montreal

**Contacts:**

***Contact 1:***

- **Email:** rene.voyer@umontreal.ca

- **Name:** René Voyer

- **Phone:** 514-343-7464

- **Role:** CONTACT

**Country:** Canada

**Facility:** Clinique dentaire Antoine Sabeh

**State:** Quebec

**Status:** RECRUITING

**Zip:** H2J 1K1

**Location 2:**

**City:** Montreal

**Contacts:**

***Contact 1:***

- **Email:** robert.durand@umontreal.ca

- **Name:** Robert Durand

- **Phone:** 514-343-7464

- **Role:** CONTACT

**Country:** Canada

**Facility:** Le Groupe des parodontistes

**State:** Quebec

**Status:** RECRUITING

**Zip:** H3H 1R6

**Location 3:**

**City:** Montreal

**Contacts:**

***Contact 1:***

- **Email:** robert.durand@umontreal.ca

- **Name:** Robert Durand, DMD, MS

- **Phone:** 514-343-7464

- **Role:** CONTACT

***Contact 2:***

- **Email:** rene.voyer@umontreal.ca

- **Name:** Rene Voyer, BS, DMD, MS

- **Phone:** 514-343-5926

- **Role:** CONTACT

***Contact 3:***

- **Name:** Robert Durand, DMD, MS

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Rene Voyer, BS, DMD, MS

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Ryma Kabir, DMD, MS

- **Role:** SUB_INVESTIGATOR

**Country:** Canada

**Facility:** Université de Montréal - Faculty of Dentistry - Dental clinics

**State:** Quebec

**Status:** RECRUITING

**Zip:** H3T 1J4

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: HIGH

- As Found: Anxiety

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001008

- Term: Anxiety Disorders

### Misc Info Module

- Version Holder: 2024-05-24
