NCT03028844已完成不适用
The Effect of a Musical Intervention on Stress Response to Venepuncture
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Salivary cortisol levels
研究概览
简要总结
Randomised Crossover Trial in Preterm Infants less than 32 weeks to assess Music therapy and sucrose versus sucrose on stress
详细描述
The purpose of this study is to assess whether the use of music therapy as a non-pharmacological intervention around the time of venepuncture significantly decreases the stress response of a stable preterm neonate, as measured by salivary cortisol levels .
The secondary aim of this study is to analyse the effect of music therapy on the EEG, and vital signs of the stable preterm neonate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 23 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born at less than 32 weeks gestational age (from 23+0 weeks' up to and including 31+6 weeks' gestational age)
- •Infants must now be >32 weeks corrected gestational age
- •Infants who are medically stable and due to have routine venepuncture as part of their management plan
排除标准
- •Inability to obtain informed consent from parent
- •Infants with known hearing impairment
- •Infants receiving sedative medications
- •Any evidence of dysfunction of the hypothalamic-pituitary-adrenal axis
- •Infants with congenital abnormalities
- •Infants with known EEG abnormalities
结局指标
主要结局
Salivary cortisol levels
时间窗: BASELINE, 20 mins and 4 hours
Change in salivary cortisol levels between Baseline, 20 minutes and 4 hours
次要结局
- Premature Infant Pain Profile (PIPP) score(immediate)
- Changes in physiological parameters - Heart rate(10 mins before venepuncture and 10 mins after)
- Changes in physiological parameters - respiration rate(10 mins before venepuncture and 10 mins after)
- Changes in physiological parameters - oxygen saturation(10 mins before venepuncture and 10 mins after)
- Changes in physiological parameters - EEG(10 mins before venepuncture and 10 mins after)
研究者
Dr. Gene Dempsey
Prof
University College Cork
研究点 (1)
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