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

Ş

Şevval Çakıcı

Status

Completed

Conditions

Dental Anxiety

Treatments

Behavioral: Music Listening Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT07350993
2024/05-32 (Registry Identifier)
CAKICIAKKOC-DENTALANXIETY

Details and patient eligibility

About

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.

Full 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.

Enrollment

78 patients

Sex

All

Ages

9 to 16 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

78 participants in 2 patient groups

Music Intervention Group
Experimental group
Description:
Children will listen to classical music during dental treatment to assess the effect on dental anxiety.
Treatment:
Behavioral: Music Listening Intervention
Control Group
No Intervention group
Description:
Children will receive dental treatment without any music intervention.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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