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临床试验/NCT06617104
NCT06617104招募中不适用

Explore the Differences in Autonomic Nervous System and Meridian Energy Between Patients With Schizophrenia and Healthy Individuals

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
meridian energy

研究概览

简要总结

This study aims to explore the differences in autonomic nervous function and meridian energy between schizophrenia patients and healthy individuals. By understanding the meridian and organ conditions of individuals, the study aims to align with the traditional Chinese medicine (TCM) concept of "treating disease before it arises" and provide comprehensive care to patients, thereby improving the quality of care.

详细描述

Data collection was conducted at a medical center in northern Taiwan. Sample size estimation was performed using G*Power 3.1. A total of 50 patients with schizophrenia were assigned to the disease group, and 50 healthy individuals were assigned to the control group, with a total of 100 participants expected. Data collection included: personal demographic questionnaire, body constitution questionnaire (BCQ), WHOQOL-BREF (Taiwan version) for quality of life, brief psychiatric rating scale (BPRS), heart rate variability (HRV), meridian energy

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Disease group:
  • Diagnosed with schizophrenia by a physician (ICD-10 code F20, such as F20.0, F20.1, F20.2, F20.3, F20.5, F20.89, or F20.9), with stable condition, and has not had any changes in medication dosage or admission to a psychiatric acute care unit in the past 3 months.
  • Aged between 18 and 65 years.
  • Able to understand, speak, read, and write Mandarin or Taiwanese.
  • Control group:
  • No history of chronic illness and no acute symptoms within the past month.
  • Aged between 18 and 65 years.
  • Able to understand, speak, read, and write Mandarin or Taiwanese.

排除标准

  • Disease group:
  • Individuals with cardiovascular conditions, severe neurological disorders (e.g., organic brain disorders, early-stage dementia or diagnosed dementia), or substance abuse issues.
  • Individuals who have used medications affecting the autonomic nervous system within the past month, such as mood stabilizers, antidepressants, angiotensin-converting enzyme inhibitors inhibitors, β-blockers, or antiarrhythmics.
  • Individuals with metallic implants that could affect heart rate variability.
  • Individuals with involuntary and uncontrollable body tremors.
  • Women currently menstruating.
  • Pregnant women.
  • Control group:
  • Individuals with cardiovascular conditions, severe neurological disorders (e.g., organic brain disorders, early-stage dementia or diagnosed dementia), or substance abuse issues.
  • Individuals who have used medications affecting the autonomic nervous system within the past month, such as psychiatric medications, angiotensin-converting enzyme inhibitors inhibitors, β-blockers, or antiarrhythmics .
  • Individuals with metallic implants that could affect heart rate variability.
  • Individuals with involuntary and uncontrollable body tremors.
  • Women currently menstruating.
  • Pregnant women.

结局指标

主要结局

meridian energy

时间窗: This study is a cross-sectional study with a single follow-up. Participants who meet the inclusion criteria will be included in the study, with a recruitment period of one year.

Measuring the body energy under static balance conditions using principles of electromagnetic induction technology.The measurement items include:lung meridian (LU), large intestine meridian (LI), stomach meridian (ST), spleen meridian (SP), heart meridian (HT), small intestine meridian (SI), bladder meridian (BL), kidney meridian (KI), pericardium meridian (PC), triple burner meridian (SJ), gallbladder meridian (GB), liver meridian (LR)

heart rate variability

时间窗: This study is a cross-sectional study with a single follow-up. Participants who meet the inclusion criteria will be included in the study, with a recruitment period of one year.

Assessing autonomic nervous system activity through the measurement of RR intervals. The measurement items include: the square root of the mean squared differences of successive NN intervals , NN50 count divided by the total number of all NN intervals, HRV triangular index, low frequency power, high frequency power, LF/HF Ratio, total power

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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