Receptive Music Interventions During Intradermal Testing in Children: A Randomized Controlled Trial Comparing Solfeggio Frequencies and Turkish Classical Music on Pain and Parental Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Parental State Anxiety Levels
研究概览
简要总结
The study summary and design were to assess procedural anxiety and stress in parents and pain perception in children during intradermal testing. Music medicine was incorporated into the study design as a nonpharmacological intervention. Two distinct auditory modalities were used: solfeggio frequencies-174 Hz, 285 Hz, 396 Hz, and 528 Hz-which have been suggested to interact with the human energy field through resonance-based mechanisms, and Turkish classical musical modes (makams), such as Rast, Hicaz, Uşşak, Neva, and Saba, which are modal systems that include microtonal intervals and follow specific melodic progressions that are often associated with different emotional and spiritual effects as well as sensory and emotional regulation potential.
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 2 and 17 years
- •Referred to the Pediatric Allergy Clinic for evaluation of suspected drug hypersensitivity reactions
- •Accompanied by a parent or legal guardian willing to participate
- •Written informed consent obtained from parents or legal guardians
排除标准
- •Known neurological, psychiatric, or developmental disorders in the child
- •Use of sedatives or analgesic medications within 24 hours prior to testing
- •Hearing impairment or auditory processing disorders in the child4.Non-consent or withdrawal of consent by parent or guardian
- •Inability of the parent to complete anxiety assessments (e.g., due to language or cognitive barriers)
研究组 & 干预措施
Control Group
Participants undergo standard intradermal testing (IDT) without any additional auditory intervention
Solfeggio Music Intervention
Participants receive receptive music therapy using Solfeggio frequencies (174 Hz, 285 Hz, 396 Hz, and 528 Hz) during the IDT procedure. Music starts five minutes before and continues throughout the procedure
干预措施: Receptive Music Therapy - Solfeggio Frequencies (Behavioral)
Traditional Turkish Music Intervention
Participants receive receptive music therapy using selected Traditional Turkish Music modes (makams), including Rast, Hicaz, Uşşak, Neva, and Saba, during the IDT procedure. Music starts five minutes before and continues throughout the procedure
干预措施: Receptive Music Therapy - Traditional Turkish Music (Behavioral)
结局指标
主要结局
Change in Parental State Anxiety Levels
时间窗: within 5 minutes before and post procedure
Change in parental state anxiety will be assessed using the State-Trait Anxiety Inventory - State Subscale (STAI-S). The STAI-S is a validated psychological inventory that measures current levels of anxiety. It consists of 20 items, each rated on a 4-point Likert scale, with total scores ranging from 20 to 80. Higher scores indicate greater levels of anxiety. STAI-S scores will be collected immediately before and immediately after the intradermal testing (IDT) procedure. The change in anxiety levels will be calculated as the difference between post-procedure and pre-procedure scores (ΔSTAI-S), and will be used to evaluate the effect of the intervention.
Pain Levels in Pediatric Patients During Intradermal Testing
时间窗: within 2 minutes post-procedure
Pain scores will be evaluated immediately after the intradermal testing (IDT) procedure. For children under 5 years of age, pain will be assessed using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS). This is a behavioral pain assessment tool with scores ranging from 4 to 13, where higher scores indicate greater pain. For children aged 5 years and older, pain will be assessed using the Wong-Baker FACES Pain Rating Scale. This self-report scale ranges from 0 to 10, where higher scores indicate greater pain.
次要结局
未报告次要终点
研究者
Hilal Gungor
Medical Doctor, Pediatric Allergy and Immunology
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization