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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Children's Anxiety Meter-State (CAM-S) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Presence of any mental or physical disability
- •History of psychiatric or developmental disorders
- •Known allergies
- •Use of medications
结局指标
主要结局
Children's Anxiety Meter-State (CAM-S) Score
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
未报告次要终点
研究者
Şevval Çakıcı
Assistant Professor,DDS
Kutahya Health Sciences University