Effect of Music on Dental Anxiety in Children: Turkish Validation of the CEDAM

NCT07350993 | Completed

• 2 other identifiers: CAKICIAKKOC-DENTALANXIETY2024/05-32
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The study will consist of two phases. In the first phase, the validity and reliability of the CEDAM scales will be assessed in children aged 9-16 years using item analysis, content and construct validity, internal consistency, and test-retest reliability. In the second phase, the effect of music will be evaluated in a randomized controlled trial involving children aged 9-12 years. The study will employ a three-session design with progressively increasing procedural invasiveness. In the final session, the control group will receive basic behavior guidance, while the intervention group will additionally listen to music during the dental procedure. Perioperative anxiety will be assessed using the Children's Anxiety Meter-State (CAM-S), Children's Emotional Manifestation Scale (CEMS), and CEDAM-8. A conceptual model will be used to examine the relationships between music intervention, preoperative anxiety, intraoperative anxiety, and postoperative anxiety.

Conditions

Dental Anxiety

Keywords

Behavior guidance; Dental anxiety; Validity; Reliability; Music

Outcome Measures

Primary Outcomes (3)

• Children's Anxiety Meter-State (CAM-S) Score

  Description: A projective measurement tool consisting of a thermometer-like scale with 10 horizontal lines. The scale evaluates state anxiety levels. Scores range from 1 to 10, where higher scores indicate higher levels of anxiety. Unit of Measure: CAM-S score

  Baseline (5 minutes before start of the dental procedure), intra-procedural (immediately after administration of local anesthesia), and post-procedural (5 minutes after completion of the dental procedure)

• Children's Emotional Manifestation Scale (CEMS) Score

  Description: An observational behavioral assessment tool that evaluates five main categories: facial expression, vocalization, activity, interaction, and cooperation. Each category is rated on a 5-point scale. Total scores range from 5 to 25, where higher scores indicate higher levels of behavioral anxiety. Unit of Measure: CEMS score

  Periprocedural (from seating in the dental chair to completion of the dental procedure)

• Children's Experiences of Dental Anxiety Measure (CEDAM-8) Score

  Description: A psychometric tool based on cognitive-behavioral therapy. It consists of 8 questions assessing thoughts, behaviors, physical symptoms, and feelings related to dental anxiety. Responses are recorded on a 3-point Likert scale. Total scores range from 8 to 24, where higher scores indicate greater dental anxiety. Unit of Measure: CEDAM-8 score

  Baseline (5 minutes before start of the dental procedure) and post-procedural (5 minutes after completion of the dental procedure)

Study Arms (2)

Music Intervention Group

EXPERIMENTAL

Children will listen to classical music during dental treatment to assess the effect on dental anxiety.

Behavioral: Music Listening Intervention

Control Group

NO INTERVENTION

Children will receive dental treatment without any music intervention.

Interventions

Music Listening Intervention BEHAVIORAL

Children will listen to classical instrumental music through headphones during the dental procedure to reduce anxiety levels.

Also known as: Classical Music Listenin

Music Intervention Group

Eligibility Criteria

• Age: 9 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 9-16 years
• Systemically healthy children
• Native Turkish speakers
• Written informed consent obtained from both the child and a parent or legal guardian

You may not qualify if:

• Presence of any mental or physical disability
• History of psychiatric or developmental disorders
• Known allergies
• Use of medications

Sponsors & Collaborators

• Şevval Çakıcı: lead

Study Sites (1)

Kütahya Health Sciences University Faculty of Dentistry

Kütahya, Kütahya, 43100, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor,DDS

Model Details: The study used a parallel-group design with two groups: a music intervention group and a control group. Participants in the intervention group listened to classical instrumental music during dental treatment, while the control group received treatment without music.

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 20, 2026
• Study Start: April 22, 2024
• Primary Completion: December 1, 2024
• Study Completion: February 21, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

TU (1)