Dental AnxietyNCT05052034
Music for Decreasing Dental Anxiety During Oral Surgery in Coronavirus Disease 2019 (COVID-19)
An observational study of Dental Anxiety and Covid19, run by European University of Madrid at 1 site in Spain.
Trial summary
Approximately 100 patients undergoing oral surgery will be divided in 3 groups of musical audition to control anxiety: baroque (N=35), classicism (N=35) and control group (N=30). Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate and Oxygen Saturation will be recorded. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Covid19
- What is being tested?
- Music
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2020to 27 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients without diseases that limit the performance of surgery, and that require the extraction of a tooth or the placement of a dental implant.
Who may be able to join
- 1. Spanish-speaking patients over 18 years of age who require the placement of a single implant or the extraction of a single tooth.
Who cannot join
- Patients with mental illness (dementia)
- Patients with psychiatric disorders
- Patients under anxiolytic treatment
- Patients with visual or motor loss or with any disability that makes it impossible to fill in the forms provided and the visual analog scale (VAS).
- Patients under medical treatment that could interfere with the anesthesia used in oral surgery.
- All implant surgeries were ruled out in patients requiring any type of bone regeneration, due to their greater morbidity.
- All oral surgeries requiring a flap, due to their greater morbidity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Musical Flow for Decreasing Dental Anxiety During Oral and Implants Surgery in COVID-19: a Randomized Controlled Study
Approximately 100 patients undergoing oral surgery will be divided in 3 groups of musical audition to control anxiety: baroque (N=35), classicism (N=35) and control group (N=30). Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate and Oxygen Saturation will be recorded.
Read the detailed description
The trend towards greater humanization in all fields of medicine encourages the implementation of non-pharmacological therapies in the management and control of pain and anxiety in patients during dental treatments. Some studies estimate this level of anxiety in up to 51% of patients, who would prefer to undergo some type of sedation during dental treatment. This fear or anxiety may have increased during the COVID-19 pandemic.
Scientific evidence recommends the use of music in daily practice to reduce anxiety and even pain. There are several studies comparing different musical styles. Some of them use a song from the so-called "classical music", but none have analyzed the possible benefits between the different stages of this type of music, which spans several centuries of history.
The purpose of this study is to verify the effect of the use of Baroque and Classical music as non-pharmacological therapy on the control of the level of intraoperative anxiety and pain experienced by patients during the COVID-19 pandemic, subjected to dental extractions. and implant placement.
This randomized controlled study would be carried out on approximately 100 patients who need tooth extractions and dental implant placement in private practice. The patients would be divided into 3 groups: baroque music, classicism music and control group. The patients would be correctly informed and would sign their consent to be part of the study. The music would be played through wireless headphones placed on the patient and connected to their respective music list according to the group to be studied. The parameters recorded during four different moments of surgery would be: systolic blood pressure, diastolic blood pressure, heart rate and oxygen saturation. After the treatment, the patient will complete a visual analog scale (VAS) on their level of pain and anxiety experienced before and after the treatment. For all of them, this surgery would be the first performed by the sole operator of the study, to reduce other subjective criteria associated with the level of pain or anxiety. Another operator would collect the data obtained.
- Conditions
- Dental Anxiety, Covid19
- Being tested
- Music
- Keywords
- Oral Implants, Oral Surgery, Dental Anxiety, Covid19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Through headphones, the patients would listen to different types of music during the intervention.
| Study group | Role | What they receive |
|---|---|---|
| BAROQUE MUSIC | This group would listen to baroque music to control their anxiety level during their oral surgeries. Receives: Other: Music | |
| CLASSICISM MUSIC | this group would listen to classical music to control their anxiety level during their oral surgeries. Receives: Other: Music | |
| CONTROL GROUP | This group would not listen to music during their oral intervention, acting as a control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure (SPB)
SPB was recorded in mmHg
Measured: SPB was recorded four times during intervention: "before starting the surgery once sitting in the chair", "immediately after anesthetizing", "immediately after introducing the first surgery drill", "immediately before getting up".
Diastolic Blood Pressure (DBP)
DBP was recorded in mmHg
Measured: SPB was recorded four times during intervention: "before starting the surgery once sitting in the chair", "immediately after anesthetizing", "immediately after introducing the first surgery drill", "immediately before getting up".
Heart Rate (HR)
HR was recorded in bpm (beats per minute)
Measured: HR was recorded four times during intervention: "before starting the surgery once sitting in the chair", "immediately after anesthetizing", "immediately after introducing the first surgery drill", "immediately before getting up".
Oxygen Saturation (Sp02)
Sp02 was recorded in % (0-100)
Measured: Sp02 was recorded four times during intervention: "before starting the surgery once sitting in the chair", "immediately after anesthetizing", "immediately after introducing the first surgery drill", "immediately before getting up".
Secondary outcomes (2)
Change from Baseline in Anxiety on the 11-point Visual Analog Scale (VAS)
The VAS is a validated instrument to identify anxiety. Possible scores range from 0 (no anxiety) to 10 (worst anxiety possible).
Measured: Baseline before starting surgery to the end of surgery approximately 40 minutes later.
Change from Baseline in Pain on the 11-point Visual Analog Scale (VAS)
The VAS is a validated instrument to identify pain. Possible scores range from 0 (no pain) to 10 (worst pain possible).
Measured: Baseline before starting surgery to the end of surgery approximately 40 minutes later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Jun 2020
- Primary completion23 Nov 2020
- Study completion27 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University of Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Ángel Esteban Pellicer, European University of Madrid
- Investigators
- Esteban Lorenzo, Principal investigator, European University of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052034
- Sponsor's protocol ID
- EuropeanUM
- Status last verified
- Dec 2022
- First submitted
- 16 Sep 2021
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All of the individual participant data collected during the study could be available since 3 years after publication for anyone who wishes to access the data, signing a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musical Flow for Decreasing Dental Anxiety During Oral and Implants Surgery in COVID-19: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05052034
- Acronym / sponsor ID
- EuropeanUM
- Conditions
- Dental Anxiety, Covid19
- Keywords
- Oral Implants, Oral Surgery, Dental Anxiety, Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- European University of MadridUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 100 patients undergoing oral surgery will be divided in 3 groups of musical audition to control anxiety: baroque (N=35), classicism (N=35) and control group (N=30). Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate and Oxygen Saturation will be recorded.
Detailed description
The trend towards greater humanization in all fields of medicine encourages the implementation of non-pharmacological therapies in the management and control of pain and anxiety in patients during dental treatments. Some studies estimate this level of anxiety in up to 51% of patients, who would prefer to undergo some type of sedation during dental treatment. This fear or anxiety may have increased during the COVID-19 pandemic.
Scientific evidence recommends the use of music in daily practice to reduce anxiety and even pain. There are several studies comparing different musical styles. Some of them use a song from the so-called "classical music", but none have analyzed the possible benefits between the different stages of this type of music, which spans several centuries of history.
The purpose of this study is to verify the effect of the use of Baroque and Classical music as non-pharmacological therapy on the control of the level of intraoperative anxiety and pain experienced by patients during the COVID-19 pandemic, subjected to dental extractions. and implant placement.
This randomized controlled study would be carried out on approximately 100 patients who need tooth extractions and dental implant placement in private practice. The patients would be divided into 3 groups: baroque music, classicism music and control group. The patients would be correctly informed and would sign their consent to be part of the study. The music would be played through wireless headphones placed on the patient and connected to their respective music list according to the group to be studied. The parameters recorded during four different moments of surgery would be: systolic blood pressure, diastolic blood pressure, heart rate and oxygen saturation. After the treatment, the patient will complete a visual analog scale (VAS) on their level of pain and anxiety experienced before and after the treatment. For all of them, this surgery would be the first performed by the sole operator of the study, to reduce other subjective criteria associated with the level of pain or anxiety. Another operator would collect the data obtained.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BAROQUE MUSIC | – | Other: MusicThis group would listen to baroque music to control their anxiety level during their oral surgeries. |
| CLASSICISM MUSIC | – | Other: Musicthis group would listen to classical music to control their anxiety level during their oral surgeries. |
| CONTROL GROUP | – | –This group would not listen to music during their oral intervention, acting as a control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients without diseases that limit the performance of surgery, and that require the extraction of a tooth or the placement of a dental implant.
Key inclusion criteria (1 listed)
- 1. Spanish-speaking patients over 18 years of age who require the placement of a single implant or the extraction of a single tooth.
Key exclusion criteria (7 listed)
- Patients with mental illness (dementia)
- Patients with psychiatric disorders
- Patients under anxiolytic treatment
- Patients with visual or motor loss or with any disability that makes it impossible to fill in the forms provided and the visual analog scale (VAS).
- Patients under medical treatment that could interfere with the anesthesia used in oral surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicThrough headphones, the patients would listen to different types of music during the intervention. | Other | BAROQUE MUSIC, CLASSICISM MUSIC |
Primary outcome
Systolic Blood Pressure (SPB)
Time frame: SPB was recorded four times during intervention: "before starting the surgery once sitting in the chair", "immediately after anesthetizing", "immediately after introducing the first surgery drill", "immediately before getting up".
SPB was recorded in mmHg
Diastolic Blood Pressure (DBP)
Time frame: SPB was recorded four times during intervention: "before starting the surgery once sitting in the chair", "immediately after anesthetizing", "immediately after introducing the first surgery drill", "immediately before getting up".
DBP was recorded in mmHg
Heart Rate (HR)
Time frame: HR was recorded four times during intervention: "before starting the surgery once sitting in the chair", "immediately after anesthetizing", "immediately after introducing the first surgery drill", "immediately before getting up".
HR was recorded in bpm (beats per minute)
Oxygen Saturation (Sp02)
Time frame: Sp02 was recorded four times during intervention: "before starting the surgery once sitting in the chair", "immediately after anesthetizing", "immediately after introducing the first surgery drill", "immediately before getting up".
Sp02 was recorded in % (0-100)
2 secondary outcomes
Change from Baseline in Anxiety on the 11-point Visual Analog Scale (VAS)
Time frame: Baseline before starting surgery to the end of surgery approximately 40 minutes later.
Change from Baseline in Pain on the 11-point Visual Analog Scale (VAS)
Time frame: Baseline before starting surgery to the end of surgery approximately 40 minutes later.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: Undecided. All of the individual participant data collected during the study could be available since 3 years after publication for anyone who wishes to access the data, signing a data access agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esteban Lorenzo principal investigator
European University of Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Anxiety and Covid19, run by European University of Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (SPB) (time frame: SPB was recorded four times during intervention: "before starting the surgery once sitting in the chair", "immediately after anesthetizing", "immediately after introducing the first surgery drill", "immediately before getting up".). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.