KCT0002162招募中未知
Electroacupuncture for treating insomnia in cancer patients: a multicenter, assessor-blinded, randomized controlled, pilot clinical trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 79(Year)（—）
- 性别
- All
入选标准
- •1. Both male and female, aged 19 or over, but under 80 years
- •2. The Eastern Cooperative Oncology Group (ECOG) performance status = 2
- •3. Cessation of cancer-related treatments (e.g. surgery, radiotherapy, chemotherapy, immunotherapy) at least 12 weeks before the trial (except for on-going hormone therapy, which must have been initiated at least 3 weeks prior to enrollment)
- •4. Continuous insomnia related to cancer treatment or cancer itself for at least 3 months, fulfilment of The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for insomnia disorder
- •5. Total score in the Insomnia Severity Index (ISI) = 15 points
- •6. Willingness to participate in the trial and provide written consent
排除标准
- •1. Current level of sleep disorder even before the diagnosis of cancer
- •2. Severe anemia (platelet count < 60,000/µL, or hemoglobin < 8 g/dL, or absolute neutrophil count < 1,000)
- •3. A diagnosis of major depressive disorder, anxiety disorder, panic disorder, or other psychiatric disorders; caffeine, alcohol, or drug addiction; or a subscale of either anxiety or depression in Hamilton Anxiety and Depression Scale (HADS) score = 11 points
- •4. Level of cancer pain measured by numeric rating scale = 4
- •5. Six months or less life expectancy
- •6. A plan of surgery, chemotherapy, radiotherapy during the study
- •7. A recent change of types or dosages of regular medication in the previous 4 weeks to alleviate insomnia
- •8. Having taken sleeping pills as required in the previous 2 weeks to alleviate insomnia
- •9. Having undergone Korean medical treatment (e.g. acupuncture, moxibustion, cupping, herbal medicine, etc.) in the previous 4 weeks
- •10. Past history in the previous 4 weeks or a new plan during the study of initiating dietary supplements or non-pharmacologic therapies (e.g. cognitive behavioral therapy, exercise etc.) to alleviate insomnia
- •11. Working shifts or changes in day/night work schedule that could impact circadian rhythm
- •12. Suffering from pain severe enough to cause sleep disturbance or presence of any disease that could cause insomnia
- •13. Taking medication for a cardiovascular or hemostatic disorder
- •14. Abnormal findings in thyroid function test (abnormal level of free thyroxine [free T4] and thyroid stimulating hormone [TSH] < 0.1 uIU/ml or TSH > 5.1 uIU/ml)
- •15. A previous hypersensitivity reaction to acupuncture or difficulty cooperating with acupuncture therapy
- •16. The presence of implants that could interfere with electroacupuncture or a history of hypersensitivity to electrostimulation
- •17. Pregnancy, lactation, or planning a pregnancy
- •18. Having participated in other clinical trials in the previous 4weeks
- •19. Difficulty complying with the treatment, questionnaire, or study protocol
研究者
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