跳至主要内容
临床试验/NCT01870076
NCT01870076已完成不适用

Effectiveness of Healing Touch on Sleep, Pain, Anxiety, Anesthesia Emergence, Satisfaction and Cost of Care in Surgical

Shriners Hospitals for Children2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2015年12月12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
41
试验地点
2
主要终点
Healing Touch Will Improve Total Sleep Time

研究概览

简要总结

Healing Touch improves measures of sleep the night prior to surgery, thus improving surgery-related morbidity.

详细描述

Patients are to randomized into one of 4 treatment groups upon enrollment. Depending on randomization group, the study participant receives the treatment the evening before elective surgery. A polysomnographic sleep study is then completed. Plan is to review the effect of the treatment group on sleep quantity and sleep quality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
5 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 5-25 years of age, inclusive
  • Elective admission for a reconstructive operative procedure
  • Planned use of general anesthesia during the elective operative procedure
  • Written informed consent, assent and Health Insurance Portability and Accountability Act (HIPAA) release signed by parent or legal guardian

排除标准

  • History of anoxic or suspected brain injury
  • History of head injury within the last year
  • Pre-existing neurological disorder
  • History of Reynaud's syndrome
  • Intellectual disability or inability to follow directions
  • Face/head phenomena that prevent(s) proper placement of polysomnography(PSG) leads
  • Taking medication for diagnosis of cardiomyopathy

结局指标

主要结局

Healing Touch Will Improve Total Sleep Time

时间窗: 8 hours

Data from nocturnal polysomnography, specifically total number of minutes of sleep time, will be compared between the healing touch and non healing touch groups.

次要结局

  • Preoperative Cortisol Level(Labs were drawn immediately pre-op.)

研究者

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

Michele Gottschlich

Research Scientist

Shriners Hospitals for Children

研究点 (2)

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