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临床试验/NCT04177160
NCT04177160已完成不适用

The Effects of Music on Autonomic Nervous System and Anxiety in Healthy Elderly and Persons With Subjective Cognitive Decline

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年4月15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
15
试验地点
2
主要终点
Visual Analogue Scale of Anxiety

研究概览

简要总结

Subjective cognition decline (SCD) is considered as a risk factor of dementia and associates not only with further cognition deterioration but with a higher anxiety level. Anxiety may lead to decreasing cognitive function and negative impacts on the well-being and quality of life. To avoid these consequences, reducing anxiety is an important step to treat SCD. To ease anxious emotions, music has been viewed as an effective, safe and easy alternative to medication. Thus, the purpose of this study is to investigate the effects of music on reducing the anxiety of the healthy elderly and SCD and further to compare the anxiety level between SCD and healthy controls.

详细描述

Single subject pretest-posttest design was used. 12 SCD subjects was recruited from the memory clinic and 12 healthy controls from the community. The anxiety level was assessed both by self-reports (State-Trait Anxiety Inventory and Visual Analogue Scale of Anxiety) and by objective measurements related to autonomic nervous system activities (heart rate variability and electrodermal activity). The participants underwent a memory task to induce anxiety. Next, preferred music and white noise were provided in random order. The anxiety level and the effects of music intervention between SCD and healthy controls will be further compared.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • able to read and write Mandarin
  • the scores of the Montreal Cognitive Assessment (MoCA) ≥ 24

排除标准

  • cognitive status was affected by psychic problems, neurological disease or other conditions
  • people with auditory and visual impairments
  • people with obesity (BMI ≥ 27) or diabetes mellitus.

结局指标

主要结局

Visual Analogue Scale of Anxiety

时间窗: After each stimulus task and intervention: on the 10th, 15th, 20th, 25th, 35th and 40th minute.

Participants reports their immediately subjective anxiety levels.

Heart rate variability

时间窗: 45 minutes

Heart activity was transformed into low- and high-frequency power components, which represented sympathetic and parasympathetic system activities respectively. It is recorded by skin conductance sensors wearing on the 2nd to 4th finger. These sensors connect to ProComp2™ Biofeedback System to collect biofeedback data. The data is further calibrated and analyzed by CardioPro Infiniti software.

Skin conductance

时间窗: 45 minutes

Electrodermal activity related to sympathetic system response (sweating). It is recorded by skin conductance sensors wearing on the 2nd to 4th finger. These sensors connect to ProComp2™ Biofeedback System to collect biofeedback data. The data is further calibrated and analyzed by CardioPro Infiniti software.

次要结局

  • Chinese version of state-trait anxiety inventory-trait version(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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