Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Sleep Quality
研究概览
简要总结
The aim of this clinical study is to investigate the extent to which ear acupuncture has an effect on insomnia in women with breast cancer. It will be investigated whether changes in sleep quality, fatigue, quality of life, stress, and psychological well-being can be achieved. In addition, a proinflammatory cytokine will be meassured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosed non-metastatic breast CAs (TNM stage I-III)
- •Existing insomnia (difficulty falling asleep or sleeping through on at least 3 days per week for at least 3 months) according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM 5).
- •willingness to participate in the study (at least 8 out of 10 treatments)
- •Signed informed consent
排除标准
- •Ongoing or planned chemotherapy, radiation, follow-up treatment or reconstructive plastic surgery during the study period
- •Severe physical or psychopharmacologically treated psychiatric comorbidity that prevents a patient from participating in the study
- •Pregnancy
- •Participation in other clinical trials with behavioural, psychological or complementary medical interventions during the study period
- •Regular use of barbiturates, antidepressants or other sleep-inducing drugs, drug abusus, alcoholism
结局指标
主要结局
Sleep Quality
时间窗: week 5
Pittsburgh Sleep Quality Index (PSQI). The PSQI contains 19 self-assessment questions and 5 questions rated by the bed-partner or roommate. The 5 questions rated by the bed-partner or roommate are only used as clinical information and not included in qualitative analysis. The question whether a bed-partner or roommate is present is not included in qualitative analysis as well. The 18 self-assessment items are used to evaluate the sleep quality on 7 domains over the last month (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, and sleep disturbances, use of sleep medication, and daytime dysfunction). Scoring of the answers is based on a scale from 0 to 3, whereby 3 reflects the negative extreme on a Likert Scale. The total score is generated by the summation of the component scores and can vary from 0 to 21, with a higher score corresponding to a reduced sleep quality. A cut-off score of 5 indicates a "poor" sleeper.
次要结局
- Quality of Life in cancer patients(week 29)
- Fatigue(week 29)
- Psychological well-being(week 29)
- Stress(week 29)
- Adverse Events(week 17)
- Change in proinflammatory cytokine(week 5)
- Expectation(week 0)
- Sleep Quality(week 29)
研究者
Dr. med. Petra Voiss
MD
Universität Duisburg-Essen