The Feasibility of Using Green Light Phototherapy for the Management of Acute Postoperative Pain
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 1
- 主要终点
- Change in postoperative pain
研究概览
简要总结
Researchers aim to demonstrate that the use of phototherapy is feasible and may reduce acute postoperative pain based on recent literature. The primary objective is to demonstrate that displaying light-emitting diodes [LED] can be achieved in the ICU setting in after cardiac surgery.
详细描述
The primary aim of this study to determine whether or not green light phototherapy is feasible after cardiac surgery.
Patients that will be undergoing heart surgery will be recruited to the study. After surgery they will be exposed to either green or white LEDs for up to 5 hours per day and up to one week after surgery.
After their exposure to light therapy, a survey will be given to the patient which will ask questions regarding tolerance of the therapy. A survey will also be given to the staff which will query whether or not the therapy was an impediment to workflow. In addition, the medical record will be reviewed to assess opiate usage in each group as an exploratory aim which may suggest differences in pain experiences.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Status post heart surgery and are admitted in the ICU at Mayo Clinic, Florida.
排除标准
- •Patient with color blindness and/or untreated cataracts.
- •Patients who are hemodynamically unstable.
- •Patients with dementia/delirium.
- •Pregnancy.
- •Patient is unwilling to participate or provide informed consent.
- •High baseline narcotic baseline requirements that would skew the baseline impact on post-op opiate pain requirements.
研究组 & 干预措施
Green light therapy group
Subjects in the intensive care unit (ICU) setting after cardiac surgery will have green light therapy via green light emitting diode (GLED) for the duration of the ICU stay or up to 1 week.
干预措施: Green light emitting diode (Device)
Placebo Group
Subjects in the intensive care unit (ICU) setting after cardiac surgery will have filtered white light emitting diodes (WLED) as a placebo for the duration of the ICU stay or up to 1 week.
干预措施: White light emitting diode (Device)
结局指标
主要结局
Change in postoperative pain
时间窗: Baseline, 1 week
Measured pain numeric rating scale from 0-10, where 0 was no pain and 10 was the worst pain imaginable. In this scale, a higher number indicates worse outcome and lower number indicates better outcome.
次要结局
未报告次要终点
研究者
Sean P. Kiley
Principal Investigator
Mayo Clinic