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临床试验/NCT03629145
NCT03629145已完成不适用

The Effect of Live Music Therapy Interventions With Pediatric Patients Who Are Mechanically Ventilated and Sedated

Children's Healthcare of Atlanta2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2018年1月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
2
主要终点
Heart Rate

研究概览

简要总结

The study is a randomized controlled trial of pediatric patients ages birth to two years of age who are mechanically ventilated and sedated as a result of a respiratory virus. The experimental group will receive twenty minutes of live, preferred music with a board-certified music therapist and the control group will receive twenty minutes of recorded music, also preferred, both interventions conducted at bedside. Caregivers will take a pre and post survey.

详细描述

Data for heart rate, respiratory rate, and blood pressure will be taken for both control and experimental conditions prior to intervention, immediately following intervention, thirty minutes post, and sixty minutes post intervention. Caregivers will take the Parental Belief Scale for Hospitalized Children prior to intervention and 60 minutes poster intervention.

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
— 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients with respiratory syntactical virus, pneumonia, rhino, corona, bronchiolitis, or flu
  • mechanically ventilated
  • Patients with underlying diagnosis accepted unless listed below
  • Patients must have a primary caregiver present

排除标准

  • Patients who are oscillating
  • have a previous diagnosis of severe or profoundly deaf
  • have a suspicion of child abuse
  • in custody of the state.

研究组 & 干预措施

Live Music Therapy

Experimental

Twenty minutes of live, preferred music played on guitar and voice

干预措施: Live Music Therapy (Behavioral)

Recorded Music

Placebo Comparator

Twenty minutes of recorded music, also on guitar and voice, previously recorded by investigator

干预措施: Recorded Music Therapy (Behavioral)

结局指标

主要结局

Heart Rate

时间窗: up to sixty minutes post intervention.

Describe the effect of a live music therapy intervention on HR in patients ages 0 to 2 years who are mechanically ventilated and sedated in one PICU.

Respiratory Rate

时间窗: up to sixty minutes post intervention.

Describe the effect of a live music therapy intervention on RR in patients ages 0 to 2 years who are mechanically ventilated and sedated in one PICU.

Blood Pressure

时间窗: up to sixty minutes post intervention.

Describe the effect of a live music therapy intervention on BP in patients ages 0 to 2 years who are mechanically ventilated and sedated in one PICU.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hannah Ivey

Music Therapist, Board-Certified

Children's Healthcare of Atlanta

研究点 (2)

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