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NCT07881640
Effect of Alpha-Band Binaural Beats on Stress and Recovery in Third Molar Surgery
Conditions: Dental Anxiety, Postoperative Pain, Impacted Tooth, Binaural Beats
Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 90
Sponsor: Alperen Kalyoncu
Location: Recep Tayyip Erdoğan University, Faculty of Dentistry Rize
Summary
Preoperative anxiety and loud equipment noises, such as dental drills, create significant stress and autonomic fluctuations in patients undergoing oral surgery. Brainwave entrainment using alpha-band (10 Hz) binaural beats is a non-invasive audio method designed to promote relaxation and activate the parasympathetic nervous system. The purpose of this randomized controlled clinical trial is to evaluate the clinical effectiveness of a 10 Hz alpha-band binaural beat track embedded in continuous rain sound on reducing perioperative anxiety, maintaining hemodynamic stability, and improving postoperative recovery in patients undergoing impacted third molar extraction. Fifty-four healthy adult participants (ASA I) scheduled for impacted third molar surgery will be randomly assigned into three groups:Binaural Beats Group: Listening to 10 Hz alpha binaural beats embedded in a rain sound via active noise-cancelling (ANC) headphones during surgery. Placebo Group: Listening to rain sound only via ANC headphones during surgery. Active Control Group: Wearing ANC headphones with no audio broadcast (noise cancellation feature only). Preoperative dental anxiety, hemodynamic parameters (blood pressure, heart rate, oxygen saturation) at four distinct intraoperative stages, post-surgical stress levels, and 7-day postoperative pain/analgesic consumption will be measured and compared among the groups.
Eligibility Criteria
Inclusion Criteria:
* Systemically healthy patients classified as American Society of Anesthesiologists (ASA) physical status I
* Aged between 18 and 45 years
* Requiring surgical extraction of at least one impacted mandibular third molar
* Normal hearing acuity in both ears
* Voluntary participation and signed written informed consent
Exclusion Criteria:
* Presence of any systemic disease (ASA II or higher)
* History of hearing impairment, acoustic trauma, or tinnitus
* History of neurological disorders, epilepsy, or psychiatric conditions
* Current use of psychotropic, sedative, or analgesic medications within 48 hours prior to surgery
* Pregnancy or lactation
* Known allergy to local anesthetics or prescribed medications
* Active acute pericoronitis or severe localized infection at the surgical site
Source: ClinicalTrials.gov (NCT07881640). StuddyBuddy aggregates publicly available trial information.