NCT02515006已完成不适用
Randomized Controlled Trial of Homeopathy Compared With Treatment As Usual for Persistent Insomnia in Patients With Cancer
Adwin Life Care3 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2014年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Changes in sleep efficiency on the Insomnia Severity Index
研究概览
简要总结
Persistent insomnia is highly prevalent complaint in cancer survivors, but is seldom satisfactorily addressed. The adaptation to cancer care of a validated, cost-effective intervention may offer a practicable solution. The aim of this study was to investigate the clinical effectiveness of homeopathy for insomnia.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled to begin chemotherapy or radiotherapy
- •chemotherapy or radiotherapy
- •meet diagnostic criteria for chronic insomnia (i.e., lasting for at least one month)
- •Chronic insomnia has been defined in previous research:as the presence of (1) three or more episodes of insomnia (i.e., ≥ 30minuteSOL, ≥ 60minute wake after sleep onset (WASO), or ≤ 6.5 hour total sleep time (TST) per night) of per week and (2) daytime effects of insomnia, such as irritability, difficulty concentrating, or fatigue for at least one month.
- •have the permission of their oncologists to participate.
排除标准
- •untreated alcohol or substance abuse or dependence,
- •bipolar, or psychotic disordermedical conditions such as seizure disorder, restless leg disorder, or Parkinson's disease
- •untreated sleep disorders such as sleep apnea
- •Taking other alternative medicines
结局指标
主要结局
Changes in sleep efficiency on the Insomnia Severity Index
时间窗: From baseline to 6 Months
次要结局
- Change in Anxiety and Depression on Hospital Anxiety Depression Scale(From Baseline to 6 Months)
- Change in Quality of Life on Short Form-36 Scale(From Baseline to 6 Months)
研究者
研究点 (3)
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