Effect of Music Therapy Intervention on Heart Rate, Anxiety and Pain During Kidney Biopsy: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- State Trait Anxiety Inventory Y-1
研究概览
简要总结
Kidney biopsy (KB) is an invasive procedure that is very useful in diagnosing kidney disease in both the native kidney and the transplanted kidney. Patients undergo KB can feel anxiety and pain. Pain is considered one of the worst experiences for patients and anxiety affects the sympathetic nervous system, the endocrine system and the immune system. The aim of this preliminary study was to evaluate the influence of MTI as a complementary/nonpharmacological intervention on heart rate variability, anxiety and pain and promote more compliant behaviours during KB.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18 years
- •not severe neurological or psychiatric conditions
- •not hearing impairment
排除标准
- •age under 18 years
- •severe neurological or psychiatric conditions
- •hearing impairment
研究组 & 干预措施
music therapy group
Patients receive an individual intervention of receptive music therapy during biopsy
干预措施: music therapy intervention (Other)
Control group
Patients receive standard care
结局指标
主要结局
State Trait Anxiety Inventory Y-1
时间窗: 1 hour after biopsy
State Trait Anxiety Inventory Y-1(STAI-Y1) was used to measure how the subject felt in that moment. Subjects were asked to rate the intensity of their anxious feelings on 20 items on a four point scale: not at all, somewhat, moderately so, or very much so. STAI-Y values \<40 defined absence of anxiety, between 40 and 50 mild anxiety, 51-60 moderate anxiety, and\> 59 severe anxiety. T1 1 hour after biopsy
visual analogic scale (VAS)
时间窗: through study completion - 5 minutes after biopsy
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end. The patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.
State Trait Anxiety Inventory Y-1
时间窗: 30 minutes before biopsy
State Trait Anxiety Inventory Y-1(STAI-Y1) was used to measure how the subject felt in that moment. Subjects were asked to rate the intensity of their anxious feelings on 20 items on a four point scale: not at all, somewhat, moderately so, or very much so. STAI-Y values \<40 defined absence of anxiety, between 40 and 50 mild anxiety, 51-60 moderate anxiety, and\> 59 severe anxiety. T0 30 minutes before biopsy
次要结局
- heart rate variability(during biopsy procedure)
研究者
Loreto Gesualdo, MD
professor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari