- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07267676
Different Music Genres on Anxiety in Orthodontic Patients
November 25, 2025 updated by: Alaattin Tekeli, Kırıkkale University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kırıkkale, Turkey (Türkiye)
- Kırıkkale University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group I
Turkish classical music group
|
Patients will listen to Turkish classical music
|
|
Active Comparator: Group II
Patient selected music group
|
Patient selected music
|
|
No Intervention: Group III
Silence
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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)
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.
|
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)
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.
|
Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2025
Primary Completion (Actual)
October 1, 2025
Study Completion (Actual)
October 15, 2025
Study Registration Dates
First Submitted
November 18, 2025
First Submitted That Met QC Criteria
November 25, 2025
First Posted (Actual)
December 5, 2025
Study Record Updates
Last Update Posted (Actual)
December 5, 2025
Last Update Submitted That Met QC Criteria
November 25, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2025/10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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