The Effects of Bright White Light Therapy on Fatigue, Sleep, Distress, Depression and Anxiety in the Hospitalized Leukemia Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Level of fatigue
研究概览
简要总结
This trial investigates how well bright white light therapy works in improving sleep, fatigue, distress, depression, and anxiety, side effects that are often experienced during an intense leukemia treatment regimen, in hospitalized leukemia patients. Bright white light therapy may help to control these symptoms, and information from this study may help doctors and nurses learn more about methods for decreasing these symptoms.
详细描述
PRIMARY OBJECTIVE:
I. To assess the efficacy of bright white light therapy (BWLT) on fatigue in patients diagnosed with leukemia during their hospitalization.
SECONDARY OBJECTIVES:
I. To assess the efficacy of BWLT on sleep disturbance in patients diagnosed with leukemia during their hospitalization.
I. To assess the efficacy of BWLT on anxiety in patients diagnosed with leukemia during their hospitalization.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to the Acute Leukemia Unit for an anticipated stay of 3 weeks or longer
- •English speaking
- •Able to comprehend and sign a consent form
- •Able to read and complete surveys
- •Alert and oriented
- •Without BWLT for seven days prior to initiating the trial
排除标准
- •Current eye disorders which is defined as:
- •Iritis, uveitis, keratitis, cataract, glaucoma, macular degeneration, retinal detachment, or retinitis pigmentosa
- •Diagnosed bipolar disorder
- •Persons with pacemakers
- •The manufacturer of the BWLT unit used for this study mentions the light unit contains magnets
结局指标
主要结局
Level of fatigue
时间窗: Up to one month after discharge
Will be assessed by Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue. Will fit a mixed model of fatigue as a function of time and group.
次要结局
- Anxiety(Up to one month after discharge)
- Sleep disturbance(Up to one month after discharge)
- Distress(Up to one month after discharge)
- Depression(Up to one month after discharge)
研究者
Shelly Brown
Principal Investigator
Ohio State University Comprehensive Cancer Center