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临床试验/NCT06472154
NCT06472154已完成不适用

he Effect of Chinese Five-element Music Based on Midnight-noon Ebb-flow Theory on Depression and Anxiety Among Older Adults

University of Malaya1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
1
主要终点
Hamilton Depression Rating Scale (HAM-D)

研究概览

简要总结

Depression and anxiety among the older adults is an issue that cannot be ignored at present. Compared to traditional pharmacological treatments and electroconvulsive therapy, non pharmacological treatments with fewer side effects, such as music-based intervention, are also effective and more easily accepted for the treatment of depression and anxiety in the older adults. In China, there have been some researches conducted Chinese five elements music as a clinical treatment for relieving depression and anxiety disorders in patients. However, there is few research on the impact of Chinese five elements music-based intervention based on midnight-noon ebb-flow theory on depression and anxiety in the older adults. This study investigated the intervention effect of Chinese five elements music-based intervention accompanied by midnight-noon ebb-flow theory on depression and anxiety in older adults.

详细描述

Depression and anxiety among the older adults is an issue that cannot be ignored at present. Compared to traditional pharmacological treatments and electroconvulsive therapy, non pharmacological treatments with fewer side effects, such as music-based intervention, are also effective and more easily accepted for the treatment of depression and anxiety in the older adults. In China, there have been some researches conducted Chinese five elements music as a clinical treatment for relieving depression and anxiety disorders in patients. However, there is few research on the impact of Chinese five elements music-based intervention based on midnight-noon ebb-flow theory on depression and anxiety in the older adults. This study investigated the intervention effect of Chinese five elements music-based intervention accompanied by midnight-noon ebb-flow theory on depression and anxiety in older adults. This study intervened in music-based intervention for 86 older adults with depression and anxiety, and divided the 86 subjects into an experimental group (with Chinese five elements music based on midnight-noon ebb-flow theory) and a control group (with Chinese five elements music). This study used the Hamilton Depression Scale, Hamilton Anxiety Scale, and the Quality of Life Enjoyment and Satisfaction Questionnaire as assessment instruments after the intervention. According to the evaluation results, it was found that compared with traditional Chinese five elements music, the intervention of Chinese five elements music with midnight-noon ebb-flow theory is more effective in alleviating depression in the older adults. This study will provide a scientific basis for further study of the timing mechanism of the five elements theory and further advance the benefits of Traditional Chinese Time Medicine.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants' HAM-D scores should be greater than 8 and HAM-A scores should be greater than
  • Patients should be older than or equal to 60 years of age.
  • Patients have no other psychiatric disorders and are not taking psychotropic medication to improve symptoms.
  • They participate voluntarily in this experiment.

排除标准

  • People who did not meet the diagnostic criteria. .
  • Who have participated in other clinical trials within the last four weeks.
  • Graduates of music studies or workers who are involved in music.
  • People suffering from hearing impairment or other severe chronic psychiatric disorders.
  • People who are under psychotropic medication.

结局指标

主要结局

Hamilton Depression Rating Scale (HAM-D)

时间窗: 12 months

The 17 items of the original HAM-D measure the degree of depression, feelings of guilt, suicidal thoughts, insomnia, ability to work and be active, language and cognitive retardation, agitation, anxiety (psychological and somatic), gastrointestinal, genital or general symptoms, hypochondriasis, weight loss and awareness of illness. Similar to the HAM-A, more than half of the items have values between 0 and 4. All other values are between 0 and 2, with the exception of weight loss (0-3). Individuals who score between 0 and 7 are considered normal or in remission. According to UF Health (2011b), a total score of more than 20 is considered an indication of at least moderate to severe depression

Hamilton Anxiety Rating Scale (HAM-A)

时间窗: 12 months

The 14 items of the HAM-A relate to psychological and somatic symptoms such as tension, insomnia, nervousness, depression and somatic symptoms. They also cover behavioral problems identified during the interview, such as restlessness or fidgeting, as well as problems with the respiratory tract, gastrointestinal tract, cardiovascular system, genitourinary system or autonomic system. With a total score of 0-56, each element is rated on a scale from 0 (not present) to 4 (extremely severe). According to UF Health (2011a), individuals who score between 0 and 7 are considered normal or in remission, a total score of less than 17 more than 7 indicates low anxiety, 18-24 indicates mild to moderate anxiety, and 25-30 indicates moderate to severe anxiety.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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