An interventional study of 10 Hz Alpha-Band Binaural Beats Track and Continuous Rain Sound (Placebo) in Dental Anxiety, Postoperative Pain and Impacted Tooth, sponsored by Alperen Kalyoncu. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Alperen Kalyoncu · Not applicable, Interventional, and Supportive care
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.
Dental anxiety and phobia are common psychological challenges that frequently lead to treatment avoidance, increased stress, and heightened pain perception during surgical procedures. High-frequency acoustic triggers generated by dental handpieces further exacerbate acute intraoperative stress and autonomic reactivity. While pharmacological management options exist, non-pharmacological neuromodulatory interventions provide safe and non-invasive alternatives with minimal side effects. Binaural beats occur when two slightly different auditory frequencies are presented separately to each ear, causing the brainstem's superior olivary complex to perceive a third oscillating frequency. Alpha-band frequencies (8-13 Hz) are associated with reduced state anxiety and enhanced parasympathetic tone. Integrating a 10 Hz binaural beat into continuous broadband masking noise (rain sound) aims to deliver therapeutic neuromodulation while simultaneously masking high-frequency clinical sounds. Study Protocol and Workflow:Preoperative Evaluation: Eligible participants complete the Modified Dental Anxiety Scale (MDAS) questionnaire in the waiting room prior to surgery. Randomization \& Blinding: Participants are randomized into three equal groups (n=30 per group) using sealed envelopes. Outcome assessors and statisticians are blinded to group allocation. Surgical Standardization: All surgical extractions are performed by a single experienced oral and maxillofacial surgeon following standardized surgical protocols (local anesthesia, mucoperiosteal flap elevation, bone drilling/tooth sectioning under saline irrigation, and primary suturing). Hemodynamic Monitoring: Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and oxygen saturation (SpO2) are recorded at four physiological stress milestones:T0: Baseline resting state in the dental chair. T1: Moment of local anesthesia administration. T2: Maximum stress period during bone drilling and tooth sectioning. T3: Recovery phase following final suture placement. Postoperative Assessment: Immediately after surgery, perceived stress and discomfort are measured using a 10-point Visual Analogue Scale (VAS). Patients are provided with a 7-day pain diary to record daily maximum pain scores (VAS 0-10) and total analgesic tablet consumption.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's planned enrollment of 90 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →This is the only study on the registry with Alperen Kalyoncu as lead sponsor.
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Exclusion Criteria:
Participants in this group wear active noise-cancelling (ANC) Bluetooth headphones during the surgical procedure and listen to a 10 Hz alpha-band binaural beat track embedded in continuous relaxing rain sound.
Device: 10 Hz Alpha-Band Binaural Beats Track
Participants in this group wear identical active noise-cancelling (ANC) Bluetooth headphones during the surgical procedure and listen only to continuous relaxing rain sound without any embedded binaural beats.
Device: Continuous Rain Sound (Placebo)
Participants in this group wear identical active noise-cancelling (ANC) Bluetooth headphones during the surgical procedure with no audio broadcast, using only the active noise cancellation feature to isolate ambient clinical noises.
Device: Active Noise Cancellation (ANC)
Participants listen to a 10 Hz alpha-band binaural beat track embedded in continuous relaxing rain sound delivered via active noise-cancelling (ANC) Bluetooth headphones during the surgical procedure.
Participants listen to continuous relaxing rain sound without embedded binaural beats delivered via active noise-cancelling (ANC) Bluetooth headphones during the surgical procedure.
Participants wear active noise-cancelling (ANC) Bluetooth headphones with no audio broadcast (ANC feature active only) during the surgical procedure.
Heart Rate
Measured in beats per minute (bpm) using a digital pulse oximeter to evaluate autonomic cardiovascular response to surgical stress.
Time frame: Baseline (preoperative), during local anesthesia injection, during bone drilling/tooth sectioning, and at final suture placement
Systolic and Diastolic Blood Pressure
Measured in mmHg using an automatic digital blood pressure monitor.
Time frame: Baseline (preoperative), during local anesthesia injection, during bone drilling/tooth sectioning, and at final suture placement
Oxygen Saturation
Measured as percentage (%) using a digital pulse oximeter.
Time frame: Baseline (preoperative), during local anesthesia injection, during bone drilling/tooth sectioning, and at final suture placement
Preoperative Dental Anxiety Score
Assessed using the Modified Dental Anxiety Scale (MDAS). Total scores range from 5 (no anxiety) to 25 (extreme dental phobia).
Time frame: Preoperatively in the waiting room prior to surgery.
Postoperative Daily Pain Intensity
Daily maximum pain intensity recorded on a 10-point Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst/unbearable pain).
Time frame: Immediately after completion of the surgical procedure + Daily for 7 consecutive postoperative days.
Postoperative Daily Analgesic Consumption
Total number of prescribed analgesic tablets consumed per day.
Time frame: Daily for 7 consecutive postoperative days.
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Plan to share: No
Started Sep 2026 (actual). Primary completion is estimated for Dec 2026, 2 months after the start.
Of 1,888 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 2 months is below that.
Counting every sponsor, half of 1,901 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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