Different Music Genres on Anxiety in Orthodontic Patients

NCT07267676 | Completed

• 1 other identifier: 2025/10
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Orthodontics; Music Therapy; Turkish Classical Music; Dental Anxiety

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline (before bracket placement) and immediately after bracket placement (within 30 minutes after the intervention)

Study Arms (3)

Group I

ACTIVE COMPARATOR

Turkish classical music group

Behavioral: Turkish classical music

Group II

ACTIVE COMPARATOR

Patient selected music group

Behavioral: Patient selected music

Group III

NO INTERVENTION

Silence

Interventions

Patient selected music BEHAVIORAL

Patient selected music

Group II

Turkish classical music BEHAVIORAL

Patients will listen to Turkish classical music

Group I

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kırıkkale University: lead

Study Sites (1)

Kırıkkale University

Kırıkkale, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 5, 2025
• Study Start: June 20, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 15, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)