Clinical Efficacy Study on 5-element Music Therapy on Patients With Physically and Psychologically Unbalance After Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change From Baseline in Self-Rating Depression Scale(SDS) score at 3 Months
研究概览
简要总结
In this study, we observed the clinical effect of using music therapy of TCM to improve the status of liver depression in patients with postoperative breast cancer patients, Second we want to explore the efficacy and advantages of traditional Chinese medicine in patients with postoperative breast cancer, and to reveal the clinical use of the efficacy and superiority.
详细描述
The study is a prospective controlled trial. Sixty-four patients were divided randomly into two groups. Patients were randomly divided into the treatment group and the control group, namely, the music treatment group and the health education group. The treatment group was given at least 30 minutes of individual music therapy and group music therapy every 3 weeks. Instead, the control group was given every 3 weeks of health education preach. It will take 12 weeks for treatment and observation. The efficacy was evaluated by observing the beginning and end of the trial of the Self-Rating Anxiety Scale score, the Self-Rating Depression Scale score, and the Breast Cancer Patients' Quality of Life Scale. At the end of the treatment, we take software packages SPSS 20.0 for management and statistical analysis.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 27 Years 至 66 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •the diagnosis of breast cancer in clinical stage (Ⅰ, Ⅱ, Ⅲ) and postoperative breast cancer during one month;
- •All participants had to have clinical depression and stagnation of liver qi;
- •age 27-66;
- •participants are conscious and willing to be followed up during the treatment.
排除标准
- •Metastasis of breast cancer or serious complications;
- •Patients with major depressive disorder;
- •The past medical history of mental disorders;
- •The primary diseases including liver, kidney, cerebrovascular, cardiovascular and hematopoietic system diseases;
- •Participating in another clinical study or undergoing another intervention;
- •Patients with hearing loss.
结局指标
主要结局
Change From Baseline in Self-Rating Depression Scale(SDS) score at 3 Months
时间窗: Baseline and months 3
The SDS is validated,self-reported table assessing depression state over the past 3 month.Possible scores below 52 defined as no anxiety,range 53 to 62 is Mild anxiety,range 63 to 72 is Moderate anxiety , scores above 73 is Severe Anxiety.The higher the score the worse state change=( months 3 score -Baseline score )
Change From Baseline in Quality of Life (FACT-B score) at 3 Months
时间窗: Baseline and months 3
The FACT-B is validated,self-reported table assessing quality of life over the past 3 month. The scale evaluation breast cancer patient's quality of life for 5 - dimensional such as physiological, social\&family, emotions ; status ; breast cancer additional entries . The higher the score , the better state change=( months 3 score -Baseline score )
Change From Baseline in Self-Rating Anxiety Scale (SAS) score at 3 Months
时间窗: Baseline and months 3
The SAS is validated,self-reported table assessing anxiety state over the past 3 month.Possible scores below 50 defined as no anxiety,range 50 to 59 is Mild anxiety,range 60 to 69 is Moderate anxiety , scores above 70 is Severe Anxiety.The higher the score the worse state change=( months 3 score -Baseline score )
次要结局
未报告次要终点