Cathay General Hospital
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Taiwanese Depression Questionnaire
研究概览
简要总结
Heart rate variability (HRV) in post-stroke patients are closely related to patient mortality, neurological deterioration and overall prognosis. Anxiety and depression will demotivate the patients' will to undergo rehabilitation program, which would delay their functional recovery. The influence of acupressure over the auricle on the HRV, anxiousness and depressive mood have yet to be verified. The investigators aimed to study the effect on auricular acupressure treatment between the different trending of HRV, anxiety and depression and their correlations.
This is a randomized control study, consisted of 70 patients with post-stroke depressive mood, from both CGH and Xizhi Cathay hospital in Taiwan. HRV analysis is performed on the first 24 hours, and on a weekly basis for a total of 6 weeks. The included depressed patients were defined by the "Hospital Anxiety and Depression Scale" and weekly will be undertaken by the patients. A "Taiwanese Depression Questionnaire" pre-test and after-test will be undertaken by the patients. Experimental group will receive acupressure treatment by the second week, trice daily, 3~5minutes each session for a course of four weeks. Data were analyzed using SPSS 20.0, using generalized estimating equation, GEE.
The study hypothesized that the auricular acupressure treatment would improve post-stroke depression. Therefore, participants would be more willing to receive rehabilitation program. Our study would also help to provide future references on related studies.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 20 years old
- •Within 24 hours of arriving at the hospital with the first symptoms of stroke
- •Hemorrhagic stroke:nontraumatic hemorrhagic stroke and Intracerebral Hemorrhage score 0-1
- •Infarct stroke:National Institutes of Health Stroke Scale less than 30
- •Able to express themselves through oral or written communication
- •Hospital Anxiety and Depression Scale Score equal to or greater than 11
排除标准
- •Previous diagnosis of arrhythmia
- •Mental illness, dementia, Alzheimer's disease, or possible complete paralysis on imaging
- •Subarachnoid hemorrhage, subdural hemorrhage, epidural hemorrhage
- •Patients with acute myocardial infarction
- •There is a wound or lesion at the ear auricular point
结局指标
主要结局
Taiwanese Depression Questionnaire
时间窗: 4 Weeks
The Taiwanese Depression Questionnaire(TDQ), which is a 4-point scale with 18 items, is a culturally specific depression self-rating instrument for effective screening of depression in Taiwan and has satisfactory reliability and validity. Subjects are guided to rate each item on a scale from 0 to 3 on the basis of "how often you felt the physical and emotional aspects during the past week". TDQ scores range from 0 to 54. The original test authors defined three ranges for both of the scales: 0-13 (non-cases), 14-18 (doubtful cases), and 19-54(cases). The higher the score, the more severe the depression.The Taiwanese Depression Questionnaire(TDQ) had a sensitivity of 0.89 and a specificity of 0.92 .
Hospital Anxiety and Depression Scale
时间窗: 4 Weeks
The reliability of the HADS was good, with Cronbach's α coefficients of 0.86 (anxiety), 0.85 (depression), and 0.91 (total scale).The HADS consists of 14 items. Seven of the items indicate anxiety and the remaining seven items indicate depression. Each item had been answered by the patient on a four point (0-3) response category so the possible scores ranged from 0 to 21 for anxiety and 0 to 21 for depression. The original test authors defined three ranges for both of the scales: 0-7 (non-cases), 8-10 (doubtful cases), and 11-21(cases). It is possible to calculate a HADS total score by simply summing up the anxiety and depression items.
次要结局
- Heart rate variability (HRV)(4 weeks)
研究者
Hsin-tung Chen
Principal Investigator
Cathay General Hospital