Usefulness of Bright Light Therapy in the Prevention of Delirium in Patients Undergoing Hematopoietic Stem Cell Transplant (HSCT)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale
研究概览
简要总结
The purpose of this study is to find out if using bright light sessions during bone marrow transplant can prevent people from developing confusion also known as delirium.
详细描述
This is a pilot, double blind randomized study conducted in patients scheduled to undergo bone marrow transplant at the Massachusetts General Hospital. The goal of this study is to look at the usefulness of bright light therapy in the prevention of delirium in a population at high risk for developing this condition.
Delirium can develop in up to half of the people that undergo bone marrow transplant. Symptoms include changes in level of alertness, confusion, and temporary problems with memory and attention. In severe cases, it can be accompanied by agitation, paranoia(overly suspicious), and hallucinations(seeing or hearing things that are not really there).
Bright light uses no medication and is often used to treat seasonal affective depression and multiple sleep disorders. The light boxes are portable and are placed in front of individuals for about 30 minutes every day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 or older
- •Male or female
- •Patients scheduled to undergo HSCT
- •English speaking
排除标准
- •Previous history of bipolar affective disorder
- •On-going delirium
- •History of substance abuse/dependence within 6 months prior to HSCT
- •History of invasive melanoma. Patients with a history of basal cell carcinoma, melanoma in situ, or squamous cell carcinoma are permitted to enroll if the lesion(s) have been excised with negative margins
- •History of medical/dermatological conditions that make skin especially sensitive to light,such as systemic lupus erythematosus (SLE) and/or porphyria
- •Eye condition that makes eyes vulnerable to light damage
- •Concomitant use of medications that increase sensitivity to sunlight, such as the herbal supplement St. John's Wort
- •Established primary insomnia
结局指标
主要结局
Number of Participants Who Developed Delirium Based on Meeting Criteria on the Delirium Rating Scale and/or Memorial Delirium Assessment Scale
时间窗: From hospital admission until the date of first documented delirium, assessed up to 28 days post-transplant
Monday, Wednesday, and Friday assessments will begin after beginning light therapy and include the Delirium Rating Scale-Revised-98 (DRS-98)and Memorial Delirium Assessment Scale (MDAS)
次要结局
- Average Dose of Antipsychotic Medications Required to Manage Delirium(From admission to hospital to discharge, an expected average of 28 days post-transplant)
- Severity of Delirium Episodes: Memorial Delirium Assessment Scale (MDAS)(From first documented episode of delirium until discharge from the hospital, assessed up to 28 days post-transplant)
- Serum Creatinine and Blood Urea Nitrogen (BUN)(From admission to hospital to discharge, an expected average of 28 days post-transplant)
- Sodium (Na), Potassium (K), Chloride (Cl), and Carbon Dioxide (CO2)(From admission to hospital to discharge, an expected average of 28 days post-transplant)
- White Blood Cells (WBC)(From admission to hospital to discharge, an expected average of 28 days post-transplant)
- Hemoglobin (HGB)(From admission to hospital to discharge, an expected average of 28 days post-transplant)
- Hospital Length of Stay(From admission to hospital to discharge, an expected average of 28 days post-transplant)
- Red Blood Cells (RBC)(From admission to hospital to discharge, an expected average of 28 days post-transplant)
- Hematocrit (HCT)(From admission to hospital to discharge, an expected average of 28 days post-transplant)
- Platelet Count(From admission to hospital to discharge, an expected average of 28 days post-transplant)
研究者
Carlos Fernandez-Robles
Principal Investigator, MD
Massachusetts General Hospital