Dental Anxiety
Conditions
Keywords
Behavior guidance, Dental anxiety, Validity, Reliability, Music
Brief summary
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.
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.
Interventions
BEHAVIORALMusic Listening Intervention
Children will listen to classical instrumental music through headphones during the dental procedure to reduce anxiety levels.
Sponsors
Şevval Çakıcı
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
9 Years to 16 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Children's Anxiety Meter-State (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) | 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 |
| Children's Emotional Manifestation Scale (CEMS) Score | 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 |
| Children's Experiences of Dental Anxiety Measure (CEDAM-8) Score | 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed