Clinical trial NCT05052034: Music for Decreasing Dental Anxiety During Oral Surgery in Coronavirus Disease 2019 (COVID-19)
Official title: Musical Flow for Decreasing Dental Anxiety During Oral and Implants Surgery in COVID-19: a Randomized Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Anxiety
Covid19
Keywords: Oral Implants
Oral Surgery
Dental Anxiety
Covid19
Lead sponsor: European University of Madrid
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Spanish-speaking patients over 18 years of age who require the placement of a single implant or the extraction of a single tooth.

Exclusion Criteria:

1. Patients with mental illness (dementia)
2. Patients with psychiatric disorders
3. Patients under anxiolytic treatment
4. 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).
5. Patients under medical treatment that could interfere with the anesthesia used in oral surgery.
6. All implant surgeries were ruled out in patients requiring any type of bone regeneration, due to their greater morbidity.
7. All oral surgeries requiring a flap, due to their greater morbidity.

Primary outcomes:
measure: Systolic Blood Pressure (SPB)
timeFrame: 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".
measure: Diastolic Blood Pressure (DBP)
timeFrame: 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".
measure: Heart Rate (HR)
timeFrame: 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".
measure: Oxygen Saturation (Sp02)
timeFrame: 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:
measure: Change from Baseline in Anxiety on the 11-point Visual Analog Scale (VAS)
timeFrame: Baseline before starting surgery to the end of surgery approximately 40 minutes later.
measure: Change from Baseline in Pain on the 11-point Visual Analog Scale (VAS)
timeFrame: Baseline before starting surgery to the end of surgery approximately 40 minutes later.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: European University of Madrid
Study officials:
affiliation: European University of Madrid
name: Esteban Lorenzo
role: PRINCIPAL_INVESTIGATOR
References: