Effect of Music on Dental Anxiety in Children: Turkish Validation of the CEDAM (MUSIC-CEDAM)

January 9, 2026 updated by: Şevval Çakıcı

Evaluation of the Effect of Music on the Management of Dental Anxiety in Children: Turkish Validity and Reliability Study of the CEDAM-A Randomized Controlled Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted in two sequential phases. In the first phase, the cross-cultural validity and reliability of the Children's Experiences of Dental Anxiety Measure (CEDAM) will be assessed in children aged 9-16 years. In the second phase, a subgroup of children aged 9-12 years will be selected from the Phase 1 sample to participate in a randomized controlled trial evaluating the effect of a music intervention on perioperative dental anxiety. Only children requiring at least a second and third dental appointment will be eligible for Phase 2.

Study Type

Interventional

Enrollment (Actual)

78

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

  • Turkey (Türkiye)
    • Kütahya
      • Kütahya, Kütahya, Turkey (Türkiye), 43100
        • Kütahya Health Sciences University Faculty of Dentistry

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music Intervention Group
Children will listen to classical music during dental treatment to assess the effect on dental anxiety.
Behavioral: Music Listening Intervention
Children will listen to classical instrumental music through headphones during the dental procedure to reduce anxiety levels.
Other Names:
  • Classical Music Listenin
No Intervention: Control Group
Children will receive dental treatment without any music intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Anxiety Meter-State (CAM-S) Score
Time Frame: 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)

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

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

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Şevval Çakıcı

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)

April 22, 2024

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

February 21, 2025

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CAKICIAKKOC-DENTALANXIETY
  • 2024/05-32 (Registry Identifier: Kutahya Health Sciences University Non-Interventional Clinical Research Ethics Committee)

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.

Clinical Trials on Dental Anxiety

Clinical Trials on Music Listening Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe