Dental AnxietyNCT07526922
Binaural Beat Music, Stress, and Orthodontic Anxiety
A study testing Alpha Binaural Beat Music and Relaxing Music in people with Dental Anxiety and Binaural Beats, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn if alpha binaural beat-embedded relaxing music reduces anxiety and stress in adolescents undergoing orthodontic bracket placement. It will also learn about the safety and effectiveness of music-based auditory interventions. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Dental Anxiety, Binaural Beats, Procedural Stress
- What is being tested?
- Alpha Binaural Beat Music and Relaxing Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescents aged 12 to 18 years
- Undergoing orthodontic treatment
- Scheduled for orthodontic bracket placement
- Provided written informed consent; for participants younger than 16 years, consent was also obtained from a parent or legal guardian
Who cannot join
- Age younger than 12 years or older than 18 years
- Significant medical history, including psychological disorders such as anxiety or depression, hearing problems, epilepsy, attention disorders, diabetes, hypertension, dry mouth, or other systemic chronic or endocrine diseases
- Use of psychiatric medications
- Use of biotin, antihistaminic drugs, or anticholinergic drugs
- Presence of oral lesions
- Unwillingness to continue or participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale University Dentistry Faculty Department of Orthodontics
Kirikkale
About this study
Official title: Effects of Alpha Binaural Beat Music on Anxiety and Salivary Stress Biomarkers During Orthodontic Bracket Placement: A Randomized Controlled Trial
The goal of this clinical trial is to learn if alpha binaural beat-embedded relaxing music reduces anxiety and stress in adolescents undergoing orthodontic bracket placement. It will also learn about the safety and effectiveness of music-based auditory interventions.
The main questions it aims to answer are:
Read more
Does alpha binaural beat music reduce anxiety levels during orthodontic bracket placement? Does music listening reduce physiologic stress parameters and salivary stress biomarkers? Is alpha binaural beat music more effective than relaxing music alone?
Researchers will compare alpha binaural beat music and relaxing music to a control condition (headphones without audio) to see if these interventions reduce anxiety and stress during orthodontic treatment.
Participants will:
Be randomly assigned to one of three groups: alpha binaural beat music, relaxing music, or control Listen to the assigned audio (or no audio) during orthodontic bracket placement Complete anxiety questionnaires before and after the procedure Undergo measurements of blood pressure, heart rate, respiratory rate, body temperature, and oxygen saturation Provide saliva samples before and after the procedure for analysis of cortisol, alpha-amylase, and pH levels
- Conditions
- Dental Anxiety, Binaural Beats, Procedural Stress, Music-Based Intervention, Orthodontic Treatment
- Being tested
- Alpha Binaural Beat Music, Relaxing Music
- Keywords
- Orthodontics, Music Therapy, Binaural Beats, Dental Anxiety, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha Binaural Beat MusicOther
Participants listened to relaxing music embedded with alpha-frequency binaural beats (8-12 Hz) through headphones during orthodontic bracket placement. The binaural beats were generated using two tones of slightly different frequencies presented separately to each ear to induce a perceived alpha frequency associated with relaxation.
Relaxing MusicOther
Participants listened to relaxing instrumental music through headphones during orthodontic bracket placement. The music was designed to provide a calming auditory environment and reduce procedural anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Alpha binaural beat music | Experimental | Participants listen to relaxing music embedded with alpha-frequency binaural beats through headphones during orthodontic bracket placement. The audio is designed to promote relaxation and reduce anxiety by inducing alpha brainwave activity (8-12 Hz). Receives: Other: Alpha Binaural Beat Music |
| Relaxing music | Experimental | Participants listen to relaxing instrumental music through headphones during orthodontic bracket placement. The music is structured to provide a calming auditory environment and reduce procedural anxiety. Receives: Other: Relaxing Music |
| Control (no audio) | No intervention | Participants wear headphones during orthodontic bracket placement but do not receive any auditory stimulus. This group serves as the control condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety Level (STAI-S)
The State-Trait Anxiety Inventory State Form (STAI-S) assesses temporary state anxiety levels. Scores range from 20 to 80, with higher scores indicating higher anxiety.
Measured: Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Change in Dental Anxiety (ACDAS)
The Abeer Children Dental Anxiety Scale (ACDAS) measures dental anxiety in children and adolescents. Scores range from 13 to 39, with higher scores indicating higher anxiety.
Measured: : Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Secondary outcomes (8)
Change in Salivary Cortisol Levels
Change in salivary cortisol concentration (micrograms per deciliter (µg/dL)) as a biomarker of stress.
Measured: Saliva samples were obtained between 10:00 AM and 12:00 PM, Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Change in Salivary Alpha-Amylase Levels
Change in salivary alpha-amylase activityin units/mililiter (U/mL))as an indicator of sympathetic nervous system activation.
Measured: Saliva samples were obtained between 10:00 AM and 12:00 PM, Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Change in Salivary pH
Change in salivary pH levels as a physiological marker associated with stress response. Salivary pH measurements were performed using pH indicator strips (range: pH 4.0-7.0)
Measured: Saliva samples were obtained between 10:00 AM and 12:00 PM, Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Change in heart rate
Changes in heart rate (beats per minute), will be recorded as indicators of physiological anxiety.
Measured: Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Changes in blood pressure
Changes in blood pressure (mmHg) will be recorded will be recorded as indicators of physiological anxiety.
Measured: Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Changes in respiratory rate
Changes in respiratory rate (breaths/minute) will be recorded as indicators of physiological anxiety.
Measured: Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Changes in body temperature
Changes in body temperature (degrees celcius) will be recorded as indicators of anxiety
Measured: Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Changes in oxygen saturation
Changes in oxygen saturation (%), will be recorded as indicators of physiological anxiety.
Measured: Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 May 2025
- Primary completion30 Sep 2025
- Study completion15 Oct 2025
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaattin Tekeli, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526922
- Sponsor's protocol ID
- 2025.04.01
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Alpha Binaural Beat Music on Anxiety and Salivary Stress Biomarkers During Orthodontic Bracket Placement: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07526922
- Acronym / sponsor ID
- 2025.04.01
- Conditions
- Dental Anxiety, Binaural Beats, Procedural Stress, Music-Based Intervention, Orthodontic Treatment
- Keywords
- Orthodontics, Music Therapy, Binaural Beats, Dental Anxiety, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if alpha binaural beat-embedded relaxing music reduces anxiety and stress in adolescents undergoing orthodontic bracket placement. It will also learn about the safety and effectiveness of music-based auditory interventions.
The main questions it aims to answer are:
Does alpha binaural beat music reduce anxiety levels during orthodontic bracket placement? Does music listening reduce physiologic stress parameters and salivary stress biomarkers? Is alpha binaural beat music more effective than relaxing music alone?
Researchers will compare alpha binaural beat music and relaxing music to a control condition (headphones without audio) to see if these interventions reduce anxiety and stress during orthodontic treatment.
Participants will:
Be randomly assigned to one of three groups: alpha binaural beat music, relaxing music, or control Listen to the assigned audio (or no audio) during orthodontic bracket placement Complete anxiety questionnaires before and after the procedure Undergo measurements of blood pressure, heart rate, respiratory rate, body temperature, and oxygen saturation Provide saliva samples before and after the procedure for analysis of cortisol, alpha-amylase, and pH levels
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alpha binaural beat music | Experimental | Other: Alpha Binaural Beat MusicParticipants listen to relaxing music embedded with alpha-frequency binaural beats through headphones during orthodontic bracket placement. The audio is designed to promote relaxation and reduce anxiety by inducing alpha brainwave activity (8-12 Hz). |
| Relaxing music | Experimental | Other: Relaxing MusicParticipants listen to relaxing instrumental music through headphones during orthodontic bracket placement. The music is structured to provide a calming auditory environment and reduce procedural anxiety. |
| Control (no audio) | No intervention | –Participants wear headphones during orthodontic bracket placement but do not receive any auditory stimulus. This group serves as the control condition. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adolescents aged 12 to 18 years
- Undergoing orthodontic treatment
- Scheduled for orthodontic bracket placement
- Provided written informed consent; for participants younger than 16 years, consent was also obtained from a parent or legal guardian
Key exclusion criteria (6 listed)
- Age younger than 12 years or older than 18 years
- Significant medical history, including psychological disorders such as anxiety or depression, hearing problems, epilepsy, attention disorders, diabetes, hypertension, dry mouth, or other systemic chronic or endocrine diseases
- Use of psychiatric medications
- Use of biotin, antihistaminic drugs, or anticholinergic drugs
- Presence of oral lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha Binaural Beat MusicParticipants listened to relaxing music embedded with alpha-frequency binaural beats (8-12 Hz) through headphones during orthodontic bracket placement. The binaural beats were generated using two tones of slightly different frequencies presented separately to each ear to induce a perceived alpha frequency associated with relaxation. | Other | Alpha binaural beat music |
| Relaxing MusicParticipants listened to relaxing instrumental music through headphones during orthodontic bracket placement. The music was designed to provide a calming auditory environment and reduce procedural anxiety. | Other | Relaxing music |
Primary outcome
Change in Anxiety Level (STAI-S)
Time frame: Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
The State-Trait Anxiety Inventory State Form (STAI-S) assesses temporary state anxiety levels. Scores range from 20 to 80, with higher scores indicating higher anxiety.
Change in Dental Anxiety (ACDAS)
Time frame: : Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
The Abeer Children Dental Anxiety Scale (ACDAS) measures dental anxiety in children and adolescents. Scores range from 13 to 39, with higher scores indicating higher anxiety.
8 secondary outcomes
Change in Salivary Cortisol Levels
Time frame: Saliva samples were obtained between 10:00 AM and 12:00 PM, Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Change in Salivary Alpha-Amylase Levels
Time frame: Saliva samples were obtained between 10:00 AM and 12:00 PM, Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Change in Salivary pH
Time frame: Saliva samples were obtained between 10:00 AM and 12:00 PM, Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Change in heart rate
Time frame: Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Changes in blood pressure
Time frame: Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Changes in respiratory rate
Time frame: Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Changes in body temperature
Time frame: Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Changes in oxygen saturation
Time frame: Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alpha Binaural Beat Music and Relaxing Music in people with Dental Anxiety and Binaural Beats, run by Kırıkkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety Level (STAI-S) (time frame: Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.