Can music at a frequency of 432 Hz reduce dental anxiety in patients undergoing tooth extraction?
| ISRCTN | ISRCTN28195632 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28195632 |
| Secondary identifying numbers | 195/2018 |
- Submission date
- 11/12/2018
- Registration date
- 23/01/2019
- Last edited
- 10/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
It has been observed that music therapy allows controlling the clinical levels of anxiety of patients undergoing several treatments. However, there is still controversy regarding the effects of music at a frequency of 432 Hz, and the real difference discernible with the music at 440 Hz.
The aim of this study is to compare the effects of music at 432 Hz on the clinical perception of anxiety and levels and salivary cortisol in patients undergoing a surgical procedure like a tooth extraction.
Who can participate?
Patients over the age of 15 to 3 5who attend the Austral University of Chile dental service.
What does the study involve?
Participants are asked to join this study while they are at the Austral University of Chile dental clinics. Participants must score 9 or higher in MDAS anxiety score. Participants are randomly allocated to one of three groups (432 Hz, 440Hz or control), and they will be exposed to relaxing piano music (Giorgio Constantini album "Dreamers") 432 Hz or 440 Hz, during 15 minutes. Saliva samples are taken before and after the music stimulation, participants also complete the anxiety questionnaires after the music stimulation.
Where is the study run from?
At the Dental clinics of the Austral University of Chile, Valdivia.
When is the study starting and how long is it expected to run for?
January 2019 to March 2019
Who is funding the study?
Austral University of Chile, Valdivia, Chile.
Who is the main contact?
Dr. Pedro Aravena
paravena@uach.cl
Contact information
Scientific
Universidad Austral de Chile. Valdivia. Chile
Valdivia
5111434
Chile
 ORCID ID |
0000-0003-1230-4573 |
|---|
Study information
| Study design | Interventional, randomised parallel clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format |
| Scientific title | Effect of music at 432 Hz in dental anxiety and salivary cortisol levels in patients undergoing tooth extraction. A randomized clinical trial. |
| Study acronym | N/A |
| Study objectives | Musical stimulation at a frequency of 432 Hz is more effective in decreasing salivary cortisol levels and dental anxiety compared to music at a frequency of 440 Hz in patients undergoing tooth extraction. |
| Ethics approval(s) | The Scientific Ethics Committee of the Valdivia Health Service in Chile, 05/07/2018, ref. 95/2018. |
| Health condition(s) or problem(s) studied | Dental anxiety |
| Intervention | The study will consist of three arms, the participants of the three groups will be randomized by a simple randomization using an online randomizer. All the participants will be intervened once, when they come to the clinics for a tooth extraction. Each participant before the tooth extraction will answer the CORAH MDAS anxiety scale, and those who obtain a score of 9 or above will apply. A saliva sample will be collected from each participant before the intervention. The first group will receive music (Giorgio Constantini “Dreamers”) at a frequency of 432 Hz during 15 minutes with headphones at a moderate volume, then a second saliva sample will be taken and he will answer the anxiety questionary again. The second group will receive music (Giorgio Constantini “Dreamers”) at a frequency of 440 Hz during 15 minutes with headphones at a moderate volume, then a second saliva sample will be taken and he will answer the anxiety questionary again. The third group will not be exposed to music, patients will be set in the dental unit during 15 minutes after the first saliva sample, then a second saliva sample will be taken and he will answer the anxiety questionary again. Then the profesional will proceed with the tooth extraction as normal. |
| Intervention type | Other |
| Primary outcome measure | 1. Dental anxiety will be measured using the CORAH- MDAS questionnaire before and after music stimulation. 2. Salivary Cortisol will be measured using 3 ml of unstimulated saliva before and after music stimulation. 2.1. Saliva samples will be transported under refrigeration conditions and then frozen at -20 ºC until laboratory analysis. 2.2. For statistical analysis, the amount of saliva secreted will be expressed in mL / min and cortisol expressed in ug / dl. |
| Secondary outcome measures | N/A |
| Overall study start date | 01/04/2018 |
| Completion date | 01/03/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 25 patients |
| Total final enrolment | 42 |
| Key inclusion criteria | 1. A Modified Dental Anxiety Scale in Spanish (MDAS) score greater > 9 points 2. 15 to 30 years of age 3. ASA I 4. Requiring simple tooth extraction. |
| Key exclusion criteria | 1. Suffering from systemic diseases 1.1. Diabetes 1.2. Immunosuppression 1.3. Hypertension 1.4. Thyroid pathology 1.5. Heart disease 1.6. Alcoholism 1.7. Pheochromocytoma 1.8. Cushing's syndrome 2. Heavy smokers (consumption of > 10 cigarettes a day) 3. Receiving permanent pharmacological treatment 3.1. Tricyclic antidepressants, 3.2. Anticholinergics 3.3. Benzodiazepines 3.4. Antihypertensives 3.5. Diuretics 3.6. Phenothiazines 3.7. Narcotics 3.8. Synthetic glucocorticoids (prednisone and prednisolone) 3.9. Phenytoin 4. Pregnant women 5. Pericoronitis or infection at the time of surgery or 10 days before surgery. |
| Date of first enrolment | 01/01/2019 |
| Date of final enrolment | 01/03/2019 |
Locations
Countries of recruitment
- Chile
Study participating centre
Valdivia
5111710
Chile
Sponsor information
University/education
Campus Isla Teja S/N. Valdivia. Chile.
Valdivia
5111434
Chile
"ROR" |
https://ror.org/029ycp228 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/04/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | Data will be shared on OSF https://osf.io/ya3dx from 05/04/2019. Data will be exported in CVS anonimized by R package Anonimizer and will not have restriction for access by a GNU General Public License (GPL) 3.0. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 11/05/2020 | 10/09/2021 | Yes | No |
Editorial Notes
10/09/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
