Dental AnxietyNCT07881640
Effect of Alpha-Band Binaural Beats on Stress and Recovery in Third Molar Surgery
A study testing 10 Hz Alpha-Band Binaural Beats Track and Active Noise Cancellation (ANC) in people with Dental Anxiety and Postoperative Pain, run by Alperen Kalyoncu at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Postoperative Pain, Impacted Tooth
- What is being tested?
- 10 Hz Alpha-Band Binaural Beats Track and Active Noise Cancellation (ANC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Sep 2026to 30 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Recep Tayyip Erdoğan University, Faculty of Dentistry
Rize
Alperen Kalyoncu, alperen.kalyoncu@erdogan.edu.tr
About this study
Official title: Effect of Alpha-Band Binaural Beats on Hemodynamic Stability, Surgical Stress, and Postoperative Recovery in Impacted Third Molar Surgery: A Randomized Controlled Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Dental Anxiety, Postoperative Pain, Impacted Tooth, Binaural Beats
- Being tested
- 10 Hz Alpha-Band Binaural Beats Track, Continuous Rain Sound (Placebo), Active Noise Cancellation (ANC)
- Keywords
- Binaural Beats, Alpha Band, Dental Anxiety, Third Molar Surgery, Hemodynamic Stability, Audio Analgesia
- Medical subject headings
- Pain, Postoperative, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 Hz Alpha-Band Binaural Beats TrackDevice
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.
Continuous Rain Sound (Placebo)Device
Participants listen to continuous relaxing rain sound without embedded binaural beats delivered via active noise-cancelling (ANC) Bluetooth headphones during the surgical procedure.
Active Noise Cancellation (ANC)Device
Participants wear active noise-cancelling (ANC) Bluetooth headphones with no audio broadcast (ANC feature active only) during the surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Binaural Beats Group | Experimental | 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. Receives: Device: 10 Hz Alpha-Band Binaural Beats Track |
| Placebo Group | Placebo comparator | 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. Receives: Device: Continuous Rain Sound (Placebo) |
| Active Control Group | Active comparator | 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. Receives: Device: Active Noise Cancellation (ANC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Measured in beats per minute (bpm) using a digital pulse oximeter to evaluate autonomic cardiovascular response to surgical stress.
Measured: 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.
Measured: 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.
Measured: Baseline (preoperative), during local anesthesia injection, during bone drilling/tooth sectioning, and at final suture placement
Secondary outcomes (3)
Preoperative Dental Anxiety Score
Assessed using the Modified Dental Anxiety Scale (MDAS). Total scores range from 5 (no anxiety) to 25 (extreme dental phobia).
Measured: 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).
Measured: 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.
Measured: Daily for 7 consecutive postoperative days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start28 Sep 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are allocated to one of three parallel arms (Binaural Beats, Placebo Rain Sound, or Active Control ANC) in a 1:1:1 ratio.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alperen Kalyoncu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alperen Kalyoncu, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881640
- Sponsor's protocol ID
- RTEU-OD-2026-01
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No