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临床试验/NCT04280744
NCT04280744已完成不适用

Feasibility of a Music Therapy Intervention to Decrease Stress During Pediatric Critical Care

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2020年6月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
Feasibility of participant recruitment

研究概览

简要总结

Admission into a pediatric intensive care unit (PICU) is a highly stressful experience for child and family. High levels of stress can negatively impact outcomes, yet non-pharmacological interventions to decrease stress in the PICU are severely lacking. This is a prospective, single-arm feasibility trial that will explore the feasibility and acceptability of a music therapy intervention to decrease stress in the PICU among families of children receiving invasive or noninvasive mechanical ventilation.

Objectives: The aims of this study are to: 1) Assess the feasibility of implementing a music therapy intervention in the PICU among children receiving invasive or non-invasive mechanical ventilation; 2) Determine the acceptability of the music therapy intervention in the ICU among caregivers, patients, and pediatric and cardiac ICU staff; 3) Explore the variability in child and caregiver stress outcomes throughout ICU admission. Hypothesis: The music therapy intervention will be feasible, as determined by recruitment, retention, protocol adherence, and data collection rates, and will be acceptable to participants and to PICU staff.

Sample: This study will recruit 20 families that include children aged 2 months - 17 years old admitted with an expected length of ICU stay greater than 72 hours. Of these 20 families, the investigators will specifically recruit 10 families whose child is admitted for a hypoxic brain injury. Eligible children are receiving either noninvasive mechanical ventilation (i.e., continuous or bilevel positive airway pressure), invasive mechanical ventilation, or have an established tracheostomy tube and with escalated support settings. One primary caregiver will be enrolled along with the child admitted into the ICU.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
2 Months 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Parent/caregiver aged 18 years or older.
  • Children aged 2 months - 17 years admitted to the PICU with an expected length of stay greater than 72 hours
  • Child is receiving either noninvasive mechanical ventilation (i.e., continuous or bilevel positive airway pressure), invasive mechanical ventilation, or have an established tracheostomy tube and with escalated support setting

排除标准

  • The legal guardian is unclear,
  • Caregiver does not read, write, and speak English
  • Child is not expected to survive that PICU stay or has care limitations in place
  • Child has deafness in both ears, in foster care or justice system, or experiences musicogenic epilepsy.

结局指标

主要结局

Feasibility of participant recruitment

时间窗: Throughout study completion, anticipated 1 year

Feasibility of participant recruitment will be determined via recruitment rate

Feasibility of participant retention

时间窗: Post-intervention completion, anticipated 2 weeks

Feasibility of participant retention will be determined via retention

Feasibility of protocol

时间窗: Throughout study completion, anticipated 1 year

Feasibility of protocol will be determined via percentage of sessions that adhere to protocol

Acceptability of intervention among participants

时间窗: Post-intervention, anticipated 2 weeks

Acceptability will be assessed via interviews with participants (caregivers and children 8 years and older) to ascertain intervention benefits, barriers, and potential optimizations.

Feasibility of data collection

时间窗: Throughout study completion, anticipated 1 year

Feasibility of data collection will be determined via percentage of participants with complete data capture

次要结局

  • Change in heart rate(Throughout intervention completion, anticipated 2 weeks)
  • Change in blood pressure(Throughout intervention completion, anticipated 2 weeks)
  • Change in oxygen saturation(Throughout intervention completion, anticipated 2 weeks)
  • Visual Analog Scale - Anxiety(Throughout intervention completion, anticipated 2 weeks)
  • Change in saliva cortisol(Throughout intervention completion, anticipated 2 weeks)
  • Change in saliva inflammatory biomarkers(Throughout intervention completion, anticipated 2 weeks)

研究者

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

Jessica Jarvis

Postdoctoral Scholar

University of Pittsburgh

研究点 (2)

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