Dental AnxietyRCTNCT07903844
Effects of Different 432 Hz Auditory Stimuli on Physiological Stress Responses and Patient Satisfaction in Adults With Dental Anxiety During Restorative Treatment
An observational study of Dental Anxiety and Musical Therapy, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
In this four-arm randomized controlled clinical trial, 120 adults aged 18-50 years with baseline Modified Dental Anxiety Scale scores ≥13 were allocated equally to 432 Hz-based instrumental music, water sounds, human-vocal music, or a no-audio control during standardized restorative cavity preparation. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Musical Therapy, Physiological Stress
- What is being tested?
- Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2026to 2 Oct 2026
- How long will I take part?
- 1 Week
- Phase
- Observational
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants were selected from adult patients presenting to the Department of Restorative Dentistry for routine restorative dental treatment.
Who may be able to join
- Adults aged 18-50 years.
- Meeting the protocol-defined medical eligibility criteria.
- Not using regular medication.
- Modified Dental Anxiety Scale (MDAS) score ≥13.
- Presence of a Class II carious lesion in a mandibular premolar tooth.
- Carious lesion extending into dentin but not exceeding one-third of the total dentin thickness.
- Suitability for cavity preparation without local anesthesia.
Who cannot join
- Presence of a serious systemic condition.
- Use of medication.
- Smoking or alcohol consumption.
- Hearing impairment.
- Cardiac arrhythmia.
- Presence of a serious psychological disorder that could interfere with participation.
- Inability or unwillingness to tolerate the headphones used for the auditory intervention.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
DEU Restorative Dentistry, Faculty of Dentistry
Izmir, 35340
About this study
In this four-arm randomized controlled clinical trial, 120 adults aged 18-50 years with baseline Modified Dental Anxiety Scale scores ≥13 were allocated equally to 432 Hz-based instrumental music, water sounds, human-vocal music, or a no-audio control during standardized restorative cavity preparation. Heart rate, systolic and diastolic blood pressure, peripheral oxygen saturation, and body temperature were recorded before and immediately after preparation; patient satisfaction was assessed after restoration. Physiological outcomes were compared using baseline-adjusted analysis of covariance, with Holm-adjusted pairwise comparisons. The null hypothesis was that there would be no significant differences among the four study groups in changes in physiological parameters or post-treatment patient satisfaction. The alternative hypothesis was that at least one auditory intervention condition would differ from the other study conditions in physiological responses and/or patient satisfaction.
- Conditions
- Dental Anxiety, Musical Therapy, Physiological Stress
- Being tested
- Music Therapy
- Keywords
- dental anxiety, 432 Hz, auditory intervention, music, physiological stress response, restorative dentistry, patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyBehavioural
Three standardized auditory recordings were specifically prepared for the study by a music specialist: instrumental music, music containing human vocals, and water-based natural sounds. The two musical recordings were prepared with reference to a nominal A4 tuning frequency of 432 Hz.
| Study group | Role | What they receive |
|---|---|---|
| Group 1. 432 Hz Instrumental Music | Group 1-432 Hz Instrumental Music (n = 30): Participants listened to the standardized instrumental music recording prepared at a nominal tuning frequency of 432 Hz. Receives: Behavioral: Music Therapy | |
| Group 2-Water-Based Auditory Stimulus | Participants listened to the standardized water-sound recording prepared according to the music specialist's 432 Hz-reference protocol; the exact signal-processing procedure remains to be confirmed. Receives: Behavioral: Music Therapy | |
| Group 3-432 Hz Human-Vocal Music | Participants listened to the standardized music recording containing human vocals, prepared at a nominal tuning frequency of 432 Hz. Receives: Behavioral: Music Therapy | |
| Group 4-Control | Participants underwent the same standardized restorative procedure without an auditory intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dental Anxiety Status and Patient Satisfaction
Dental anxiety will be assessed using the Modified Dental Anxiety Scale (MDAS), a five-item questionnaire with a total score ranging from 5 to 25. Higher scores indicate greater dental anxiety.
Patient satisfaction will be assessed using a five-point Likert-type scale, ranging from 1 (very dissatisfied) to 5 (very satisfied), with higher scores indicating greater satisfaction.
Measured: Baseline (before music therapy) and immediately after the dental procedure
Secondary outcomes (5)
Change in Heart Rate
Heart rate will be measured in beats per minute (bpm) using a digital pulse oximeter. Measurements will be obtained at baseline, before the auditory intervention, and immediately after completion of the standardized cavity preparation procedure. Changes in heart rate between the two measurement points will be evaluated to assess physiological responses to the dental procedure.
Measured: Baseline (immediately before the auditory intervention) and immediately after cavity preparation (approximately 10 minutes after baseline).
Change in Body Temperature
Body temperature will be measured in degrees Celsius (°C) using a digital thermometer. Measurements will be obtained at baseline, before the auditory intervention, and immediately after completion of the standardized cavity preparation procedure. Changes in body temperature between the two measurement points will be evaluated to assess physiological responses to the dental procedure.
Measured: Baseline (immediately before the auditory intervention) and immediately after cavity preparation (approximately 10 minutes after baseline).
Change in Systolic Blood Pressure
Systolic blood pressure will be measured in millimeters of mercury (mmHg) using a digital blood pressure monitor. Measurements will be obtained at baseline, before the auditory intervention, and immediately after completion of the standardized cavity preparation procedure. Changes in systolic blood pressure will be calculated as the post-procedural value minus the baseline value to assess physiological responses to the dental procedure.
Measured: Baseline (immediately before the auditory intervention) and immediately after cavity preparation (approximately 10 minutes after baseline).
Change in Diastolic Blood Pressure
Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using a digital blood pressure monitor. Measurements will be obtained at baseline, before the auditory intervention, and immediately after completion of the standardized cavity preparation procedure. Changes in diastolic blood pressure will be calculated as the post-procedural value minus the baseline value to assess physiological responses to the dental procedure.
Measured: Baseline (immediately before the auditory intervention) and immediately after cavity preparation (approximately 10 minutes after baseline).
Change in Peripheral Oxygen Saturation (SpO₂)
Peripheral oxygen saturation (SpO₂) will be measured as a percentage (%) using a digital pulse oximeter. Measurements will be obtained at baseline, before the auditory intervention, and immediately after completion of the standardized cavity preparation procedure. Changes in oxygen saturation will be calculated as the post-procedural value minus the baseline value to assess physiological responses to the dental procedure.
Measured: Baseline (immediately before the auditory intervention) and immediately after cavity preparation (approximately 10 minutes after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start10 Aug 2026
- Primary completion30 Sep 2026
- Study completion2 Oct 2026
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asli Silkü Oflioğlu, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903844
- Sponsor's protocol ID
- Approval No: 2026/29-21
- Acronym
- RCT
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different 432 Hz Auditory Stimuli on Physiological Stress Responses and Patient Satisfaction in Adults With Dental Anxiety During Restorative Treatment
- ClinicalTrials.gov ID
- NCT07903844
- Acronym / sponsor ID
- RCT / Approval No: 2026/29-21
- Conditions
- Dental Anxiety, Musical Therapy, Physiological Stress
- Keywords
- dental anxiety, 432 Hz, auditory intervention, music, physiological stress response, restorative dentistry, patient satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 2 Oct 2026 (actual)
- First posted
- 29 Oct 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.
In this four-arm randomized controlled clinical trial, 120 adults aged 18-50 years with baseline Modified Dental Anxiety Scale scores ≥13 were allocated equally to 432 Hz-based instrumental music, water sounds, human-vocal music, or a no-audio control during standardized restorative cavity preparation. Heart rate, systolic and diastolic blood pressure, peripheral oxygen saturation, and body temperature were recorded before and immediately after preparation; patient satisfaction was assessed after restoration. Physiological outcomes were compared using baseline-adjusted analysis of covariance, with Holm-adjusted pairwise comparisons. The null hypothesis was that there would be no significant differences among the four study groups in changes in physiological parameters or post-treatment patient satisfaction. The alternative hypothesis was that at least one auditory intervention condition would differ from the other study conditions in physiological responses and/or patient satisfaction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1. 432 Hz Instrumental Music | – | Behavioral: Music TherapyGroup 1-432 Hz Instrumental Music (n = 30): Participants listened to the standardized instrumental music recording prepared at a nominal tuning frequency of 432 Hz. |
| Group 2-Water-Based Auditory Stimulus | – | Behavioral: Music TherapyParticipants listened to the standardized water-sound recording prepared according to the music specialist's 432 Hz-reference protocol; the exact signal-processing procedure remains to be confirmed. |
| Group 3-432 Hz Human-Vocal Music | – | Behavioral: Music TherapyParticipants listened to the standardized music recording containing human vocals, prepared at a nominal tuning frequency of 432 Hz. |
| Group 4-Control | – | –Participants underwent the same standardized restorative procedure without an auditory intervention. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants were selected from adult patients presenting to the Department of Restorative Dentistry for routine restorative dental treatment.
Key inclusion criteria (7 listed)
- Adults aged 18-50 years.
- Meeting the protocol-defined medical eligibility criteria.
- Not using regular medication.
- Modified Dental Anxiety Scale (MDAS) score ≥13.
- Presence of a Class II carious lesion in a mandibular premolar tooth.
Key exclusion criteria (7 listed)
- Presence of a serious systemic condition.
- Use of medication.
- Smoking or alcohol consumption.
- Hearing impairment.
- Cardiac arrhythmia.
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 |
|---|---|---|
| Music TherapyThree standardized auditory recordings were specifically prepared for the study by a music specialist: instrumental music, music containing human vocals, and water-based natural sounds. The two musical recordings were prepared with reference to a nominal A4 tuning frequency of 432 Hz. | Behavioural | Group 1. 432 Hz Instrumental Music, Group 2-Water-Based Auditory Stimulus, Group 3-432 Hz Human-Vocal Music |
Primary outcome
Change in Dental Anxiety Status and Patient Satisfaction
Time frame: Baseline (before music therapy) and immediately after the dental procedure
Dental anxiety will be assessed using the Modified Dental Anxiety Scale (MDAS), a five-item questionnaire with a total score ranging from 5 to 25. Higher scores indicate greater dental anxiety. Patient satisfaction will be assessed using a five-point Likert-type scale, ranging from 1 (very dissatisfied) to 5 (very satisfied), with higher scores indicating greater satisfaction.
5 secondary outcomes
Change in Heart Rate
Time frame: Baseline (immediately before the auditory intervention) and immediately after cavity preparation (approximately 10 minutes after baseline).
Change in Body Temperature
Time frame: Baseline (immediately before the auditory intervention) and immediately after cavity preparation (approximately 10 minutes after baseline).
Change in Systolic Blood Pressure
Time frame: Baseline (immediately before the auditory intervention) and immediately after cavity preparation (approximately 10 minutes after baseline).
Change in Diastolic Blood Pressure
Time frame: Baseline (immediately before the auditory intervention) and immediately after cavity preparation (approximately 10 minutes after baseline).
Change in Peripheral Oxygen Saturation (SpO₂)
Time frame: Baseline (immediately before the auditory intervention) and immediately after cavity preparation (approximately 10 minutes after baseline).
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 29 Oct 2026.
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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?
An observational study of Dental Anxiety and Musical Therapy, run by Dokuz Eylul 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 7 inclusion and 7 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 29 Oct 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 Dental Anxiety Status and Patient Satisfaction (time frame: Baseline (before music therapy) and immediately after the dental procedure). 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 29 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.