Anxiety, Dissatisfaction, Gingival Graft, Music Intervention, Pain
Conditions
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).
Interventions
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
OTHERselected 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
Sponsors
Université de Montréal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Single-blind randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| burden of care | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| participants' expectations | 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) |
| Index of dental anxiety and fear | 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 |
| State-trait anxiety inventory (Spielberg DC et al, 1977) | 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 |
| sociodemographic data | 1 week before surgery | age, sex, gender, level of education, yearly income |
| Anxiety coping strategies | 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? ……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… |
| Cafeine and medications consumption | 1 week before surgery | mean consumption per week, # taken today (coffee, tea, sodas, energy drinks, medications = analgesics, stimulants, nutrition supplements, other medications) |
| Feelings at the present moment | 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) |
| State-trait anxiety inventory | immediately after surgery | validated general anxiety questionnaire |
Countries
Canada
Contacts
Primary ContactRobert Durand
Outcome results
None listed