None listed
Conditions
Brief summary
Background: Surgical extraction under local anesthesia of impacted third molars is a procedure that generates stress, fear and anxiety in the patient, which is why there is interest in finding and applying non-invasive therapies, with the aim of mitigating and improving these undesirable states. Music therapy and aromatherapy are disciplines on the rise in the field of medicine, especially in areas aimed at controlling pain and anxiety. Objective: The objective of the study is to evaluate the role of aromatherapy and music in the reduction of anxiety and perioperative pain in patients who undergo surgical extraction of impacted third molars under local anesthesia. Methods: a controlled clinical trial (RCT) of parallel groups has been proposed, with three groups: experimental 1 (91 patients) who will undergo the surgical extraction of the third molar receiving musical stimulation during the surgical procedure. Experimental group 2 (91 patients) to which aromatherapy will be applied during the surgical procedure. And a control group (91 patients) that will be the patients who will undergo the extraction of the third molar without receiving musical stimulation or aromatherapy during the surgical procedure. The variables to be studied will be: the evaluation of anxiety and pain in all the subjects that make up the three arms of the trial, being evaluated by means of the State and Trait Anxiety Questionnaire (STAI) and the numerical visual analogue scale (VAS). And epidemiological variables such as age, sex, dental laterality, degree of inclusion, variation in basic vital signs (FC, Sat O2, TA). Expected Results: Patients undergoing aromatherapy and music therapy are expected to have lower levels of anxiety and pain compared to the control group. Physiological parameters will also improve in the intervention group. Practical implications: The implementation of these interventions (non-invasive, non-pharmacological and inexpensive) in the field of oral and maxillofacial surgery could improve procedures performed under local anesthesia, improving the clinical experience of patients.
Interventions
Randomized clinical trial with three groups: experimental 1 (91 patients) who will undergo surgical extraction of the third molar receiving musical stimulation during the surgical procedure. Experimental group 2 (91 patients) to which aromatherapy will be applied during the surgical procedure. And control group (91 patients) that will be the patients who will undergo the extraction of the third molar without receiving musical stimulation or aromatherapy during the surgical procedure. Experimental group 1 (MUSIC group): Patients who will be included in the music therapy intervention group will receive an electronic acoustic reproduction device iPod, with wireless headphones (Trust Urban). “Introduction and Allegro for harp, flute, clarinet, and string quartet” by Ravel and “Aria” by J.S. Bach are selected as the playlist to be played during the procedure, as they are considered relaxing instrumental music. This device will allow the patient to listen to music when unaccompanied, both presurgery (in the preoperative holding area) and during surgery (in the operating room), with a duration of 20 minutes each time. In the preoperative holding area, when the patient is unaccompanied, the device will be given 20 minutes before the extraction (volume of 60-70 decibels to avoid risk of acoustic damage). The basic vital signs: systolic blood pressure (SBP), diastolic blood pressure (DBP), oxygen saturation (SAT O2) and heart rate (HR), will be taken and the STAI-Y1 and STAI-Y2 questionnaire will be carried out. After 20 minutes alone and listening to music, the patient goes to the operating room where the surgery is performed while the patient uses the music player during surgery. During surgery, new basic vital signs will be taken: systolic blood pressure (SBP), diastolic blood pressure (DBP), oxygen saturation (SAT O2) and heart rate (HR) using the same tower with which they were taken in the preoperative holding area. These constants will be taken at different times during the surgical act: during the infiltration of local anesthetic (articaine with epinephrine 40/0.005mg/ml (trade name Ultracain ®)); during the osteotomy and dental section carried out with a handpiece at 40,000 revolutions with a 23 milling cutter; and after the closure of the flap and placement of local compressive gauze. 20 minutes after the surgery, the STAI-Y1, STAI-Y2 questionnaire will be passed again and new basic vital signs will be taken. And finally, a visual analog scale (VAS) will be used to indicate the perioperative pain experienced by the patient. Intervention group 2 (AROMATHERAPY GROUP): The aromatherapy will be applied using a dispenser that will contain 100% pure lavender oil essence (4 drops in 150 ml of distilled water). The procedure will be carried out in the same way as in the intervention group with music therapy (the patient will be alone for 20 minutes in the preoperative holding area receiving the aromatherapy and then they will go to the operating room, using the device during surgery). As a strategy to monitor adherence or fidelity to the intervention, the "directly observed therapy" method will be used. To do this, a health professional will fill out a check-list in which they will verify that each patient is receiving the intervention indicated according to the protocol.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Adult patients between 18-50 years of age (age at which the eruption or the pathologies derived from the lack of eruption occures) 2. Both men and women will be selected 3. Single procedure per surgical act, that is, only one extraction per patient and episode. 4. Procedure performed under exclusive local anesthesia. 5. Patients who agree to participate in the study and sign the Informed Consent form.
Exclusion criteria
1. Patients under 18 years of age or over 50 years of age. 2. Multiple procedure, that is, dental polyextraction in the same surgical act. 3. Patients with deafness or with hearing pathology. 4. Patients with anosmia or significant loss of smell. 5. Patients who suffer from epilepsy or have had an epileptic seizure in the last 6 months. 6. Anticoagulated patients or with bleeding disorders. 7. Patients undergoing cancer treatment or immunosuppressed. 8. Patients being treated with bisphosphonates. 9. Patients with systemic pathology that may interfere with the result. 10. Patients who have received locoregional radiotherapy. 11. Previous surgery in the lower retromolar trigone area. 12. Disabled patients, non-collaborators. 13. Patients unable to understand and fill in the visual analog scale and the anxiety questionnaire. 14. Patients operated under general anesthesia and / or sedation. 15. Presence of active suppurative infection at the time of surgery. 16. Pregnant patients or possibility of pregnancy (verified by pregnancy test). 17. Patient who does not want or authorize to participate in the study or does not have a correct command or understanding of the Spanish language. 18. Patients with severe cardiac impulse conduction dysfunctions. 19. Patients with decompensated heart failure.