European University of Madrid
Madrid, Spain
NCT Number: NCT05052034
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.
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Notify Me18 year and older
All sexes
Observational
Madrid, Spain
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Through headphones, the patients would listen to different types of music during the intervention.
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
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
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)
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)
Time frame: Baseline before starting surgery to the end of surgery approximately 40 minutes later.
The VAS is a validated instrument to identify anxiety. Possible scores range from 0 (no anxiety) to 10 (worst anxiety possible).
Time frame: Baseline before starting surgery to the end of surgery approximately 40 minutes later.
The VAS is a validated instrument to identify pain. Possible scores range from 0 (no pain) to 10 (worst pain possible).
European University of Madrid
Other
Musical Flow for Decreasing Dental Anxiety During Oral and Implants Surgery in COVID-19: a Randomized Controlled Study
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