Orthodontic ApplianceNCT07267676
Different Music Genres on Anxiety in Orthodontic Patients
A study testing Patient selected music and Turkish classical music in people with Orthodontic Appliance, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn if Turkish classical music, patient-selected music, and silence have an effect on psychological and physiological anxiety indicators during orthodontic bracket placement. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Orthodontic Appliance
- What is being tested?
- Patient selected music and Turkish classical music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 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
- Patients that have completed informed consent and written consent forms
- Patients between the ages of 12-18
- Patients that were undergoing orthodontic treatment and scheduled for placement of bracket appliance.
Who cannot join
- Patients over the age of 18 and below the age of 12 years
- Patients with significant medical history (psychological disorders as anxiety or depression, hearing problems, epilepsy, attention disorders, diabetes, hypertension or other systemic chronic or endocrine diseases)
- Patients using;
- psychiatric medications
- antihistaminic
- anticholinergic drugs
- Patients that did not desire to continue or participate in the research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Different Music Genres on Anxiety in Orthodontic Patients: A Randomized Controlled Study
The goal of this clinical trial is to learn if Turkish classical music, patient-selected music, and silence have an effect on psychological and physiological anxiety indicators during orthodontic bracket placement. The main questions it aims to answer are: Does Turkish classical music reduce anxiety levels in orthodontic patients undergoing bracket placement? Does patient-selected music reduce anxiety levels in orthodontic patients undergoing bracket placement? Researchers will compare two different music genres to a control (no music, silence) to see if music therapy works to lower anxiety. Participants will: Listen to Turkish classical music or patient-selected music or silence during orthodontic bracket application and complete 2 scales before and after the intervention.
- Conditions
- Orthodontic Appliance
- Being tested
- Patient selected music, Turkish classical music
- Keywords
- Orthodontics, Music Therapy, Turkish Classical Music, Dental Anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient selected musicBehavioural
Patient selected music
Turkish classical musicBehavioural
Patients will listen to Turkish classical music
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Turkish classical music group Receives: Behavioral: Turkish classical music |
| Group II | Active comparator | Patient selected music group Receives: Behavioral: Patient selected music |
| Group III | No intervention | Silence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety Levels Measured by the Abeer Children Dental Anxiety Scale (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)
Change in State Anxiety Measured by the State-Trait Anxiety Inventory - State Form (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)
Physiological Anxiety Indicators (Heart Rate, Blood Pressure, Body Temperature, Oxygen Saturation)
Changes in heart rate (beats per minute), blood pressure (mmHg), body temperature (degrees celcius) and 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 posted5 Dec 2025
- Study start20 Jun 2025
- Primary completion1 Oct 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 Orthodontic ApplianceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 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
- NCT07267676
- Sponsor's protocol ID
- 2025/10
- Status last verified
- Jun 2025
- First submitted
- 18 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Different Music Genres on Anxiety in Orthodontic Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07267676
- Acronym / sponsor ID
- 2025/10
- Conditions
- Orthodontic Appliance
- Keywords
- Orthodontics, Music Therapy, Turkish Classical Music, Dental Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 5 Dec 2025 (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 Turkish classical music, patient-selected music, and silence have an effect on psychological and physiological anxiety indicators during orthodontic bracket placement. The main questions it aims to answer are: Does Turkish classical music reduce anxiety levels in orthodontic patients undergoing bracket placement? Does patient-selected music reduce anxiety levels in orthodontic patients undergoing bracket placement? Researchers will compare two different music genres to a control (no music, silence) to see if music therapy works to lower anxiety. Participants will: Listen to Turkish classical music or patient-selected music or silence during orthodontic bracket application and complete 2 scales before and after the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Behavioral: Turkish classical musicTurkish classical music group |
| Group II | Active comparator | Behavioral: Patient selected musicPatient selected music group |
| Group III | No intervention | –Silence |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients that have completed informed consent and written consent forms
- Patients between the ages of 12-18
- Patients that were undergoing orthodontic treatment and scheduled for placement of bracket appliance.
Key exclusion criteria (7 listed)
- Patients over the age of 18 and below the age of 12 years
- Patients with significant medical history (psychological disorders as anxiety or depression, hearing problems, epilepsy, attention disorders, diabetes, hypertension or other systemic chronic or endocrine diseases)
- Patients using;
- psychiatric medications
- antihistaminic
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 |
|---|---|---|
| Patient selected musicPatient selected music | Behavioural | Group II |
| Turkish classical musicPatients will listen to Turkish classical music | Behavioural | Group I |
Primary outcome
Change in Anxiety Levels Measured by the Abeer Children Dental Anxiety Scale (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.
Change in State Anxiety Measured by the State-Trait Anxiety Inventory - State Form (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.
Physiological Anxiety Indicators (Heart Rate, Blood Pressure, Body Temperature, Oxygen Saturation)
Time frame: Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
Changes in heart rate (beats per minute), blood pressure (mmHg), body temperature (degrees celcius) and oxygen saturation (%) will be recorded as indicators of physiological anxiety.
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 5 Dec 2025.
- Individual participant dataSharing planned: No
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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 Patient selected music and Turkish classical music in people with Orthodontic Appliance, 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 3 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 5 Dec 2025. 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 Levels Measured by the Abeer Children Dental Anxiety Scale (ACDAS) (time frame: Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)). The study lists 3 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 5 Dec 2025.