Effectiveness of Healing Touch on Sleep, Pain, Anxiety, Anesthesia Emergence, Satisfaction and Cost of Care in Surgical
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
- 是
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
Michele Gottschlich
Research Scientist
Shriners Hospitals for Children
