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

Pain Clinical Trial

Official title:

Effects of a Personalized Sound Intervention on Anxiety, Pain, and Satisfaction During Autogenous Gingival Graft in Adults: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05632679
• Other study ID #: 2021-1146
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Music Intervention
• Pain

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