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Completed

NCT Number: NCT07350993

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

The study will consist of two phases. In the first phase, the validity and reliability of the children's experiences of dental anxiety measure (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 short version of the CEDAM (CEDAM-8). A conceptual model will be used to examine the relationships between music intervention, preoperative anxiety, intraoperative anxiety, and postoperative anxiety.

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Key information

Conditions

Dental Anxiety

Age range

9 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kütahya Health Sciences University Faculty of Dentistry

Kütahya, 43100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music Listening Intervention

Behavioral

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

Other names: Classical Music Listening

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Şevval Çakıcı

Other

Registry information

Official study title

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

Acronym: MUSIC-CEDAM

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jan 20, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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