Subjective Anxiety and Physiological Parameters in First-Time Ambulatory Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Subjective Anxiety: Visual Analog Scale for Anxiety (VAS-A)
研究概览
简要总结
This study aims to investigate the effects of music intervention on subjective anxiety and physiological indicators, including heart rate, blood pressure, and heart rate variability, in first-time ambulatory surgery patients, and to compare the differential effects between self-selected and standardized music interventions.
详细描述
This study aims to investigate the effects of music intervention on subjective anxiety and physiological parameters in first-time ambulatory surgery patients. The physiological parameters include heart rate, blood pressure, and heart rate variability (HRV), while subjective anxiety will be assessed using standardized measurement scales. The study also compares the differential effects of two types of music interventions-self-selected music and standardized classical music-on patients' anxiety and physiological parameters. During the intervention, all music playback conditions, including timing, environment, and use of headphones, will be kept consistent to ensure comparability between groups. The results of this study will provide evidence on the clinical applicability of music as a non-pharmacological strategy for anxiety management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be at least 18 years old.
- •Undergo outpatient surgery for the first time.
- •Be mentally clear and able to communicate in Chinese and complete the questionnaire.
- •Agree to wear physiological monitoring devices and sign the consent form.
排除标准
- •Hearing impairment or the need to use a hearing aid.
- •Currently using sleeping pills/sedatives or having a mental illness.
- •Severe cardiovascular disease or having an implanted pacemaker.
- •Diseases that affect autonomic nervous system function.
研究组 & 干预措施
Self-selected Music Group
Participants may select and listen to light instrumental music, classical music, or natural sounds from the music list provided by the study according to their personal preference.
干预措施: Self-selected Music intervention (Behavioral)
Fixed-music Group
Playing the same piece of classical music pre-selected by the research team.
干预措施: Fixed-music Music intervention (Behavioral)
No-music
Participants wore earmuff headphones and wearable physiological monitoring devices to measure HRV, with no music played during the process.
结局指标
主要结局
Subjective Anxiety: Visual Analog Scale for Anxiety (VAS-A)
时间窗: Baseline (T0, pre-intervention); during the 10-minute intervention (T1); immediately after surgery in the postoperative recovery period (T2)]
Subjective anxiety will be assessed using the Visual Analog Scale for Anxiety (VAS-A; score range: 0-10). Higher scores indicate higher levels of anxiety. Measurements will be recorded at baseline (T0, pre-intervention), during the 10-minute intervention (T1), and immediately after surgery in the postoperative recovery period (T2).
Subjective Anxiety: State Anxiety Inventory (STAI-S)
时间窗: Baseline (T0, pre-intervention); immediately after surgery in the postoperative recovery period (T2)]
Subjective anxiety will be assessed using the State Anxiety Inventory (STAI-S; score range: 20-80). Higher scores indicate higher levels of anxiety. Measurements will be recorded at baseline (T0, pre-intervention) and immediately after surgery in the postoperative recovery period (T2).
Subjective Anxiety: Amsterdam Preoperative Anxiety and Information Scale (APAIS)
时间窗: Baseline (T0, pre-intervention)
Subjective anxiety will be assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS; score range: 6-30). Higher scores indicate higher levels of anxiety. Measurements will be recorded at baseline (T0, pre-intervention).
次要结局
- Heart Rate Variability (HRV)(Baseline (T0, pre-intervention) and during the 10-minute intervention (T1))
- Systolic Blood Pressure(Baseline (T0, pre-intervention) and during the 10-minute intervention (T1))
- Diastolic Blood Pressure(Baseline (T0, pre-intervention) and during the 10-minute intervention (T1))
- Heart Rate(Baseline (T0, pre-intervention) and during the 10-minute intervention (T1))
研究者
Yi-chen Wu
Assistant Professor
Da-Yeh University