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| ID | Type | Description | Link |
|---|---|---|---|
| 2024/05-32 | Registry Identifier | Kutahya Health Sciences University Non-Interventional Clinical Research Ethics Committee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music Intervention Group | Experimental | Children will listen to classical music during dental treatment to assess the effect on dental anxiety. |
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| Control Group | No Intervention | Children will receive dental treatment without any music intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music Listening Intervention | Behavioral | Children will listen to classical instrumental music through headphones during the dental procedure to reduce anxiety levels. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kütahya Health Sciences University Faculty of Dentistry | Kütahya | Kütahya | 43100 | Turkey (Türkiye) |
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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.
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