The Effect of Stellate Ganglion Block on Insomnia Patients: a Pre - and Post Control Experiments
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index
研究概览
简要总结
A prospective study was conducted on Insomnia Patients. All the patients were provided with Stellate Ganglion Block. The quality of sleep was evaluated to see if Stellate Ganglion Block can improve Insomnia.
详细描述
Insomnia is a sleep disorder characterized by difficulty falling asleep, staying asleep, or experiencing non-restorative sleep, despite having adequate opportunity for sleep. It is a common condition that can significantly impact an individual's quality of life and overall well-being.A prospective study was conducted on Insomnia Patients. All the patients were provided with Stellate Ganglion Block. The quality of sleep was evaluated to see if Stellate Ganglion Block can improve Insomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insomnia patients with the ages over
- •Meeting the diagnostic criteria for chronic insomnia as per the International Classification of Sleep Disorders (ICSD) or the Diagnostic and Statistical Manual of Mental Disorders (DSM).
- •Experiencing insomnia symptoms persistently for at least three months.
- •Not currently using or ceased using medication for insomnia for at least four weeks.
- •Willing to undergo Stellate Ganglion Block treatment and participate in the study.
排除标准
- •Patients with severe cardiovascular disease, pulmonary disease, or other serious physical health issues.
- •Pregnant or lactating women.
- •Patients with mental disorders (such as major depression, anxiety disorders, schizophrenia, etc.) or cognitive impairments.
- •Patients with known allergies or contraindications to Stellate Ganglion Block treatment.
- •Patients currently participating in other clinical trials or receiving experimental treatments.
研究组 & 干预措施
Stellate Ganglion Block Group
Stellate Ganglion Block Group will be given Stellate Ganglion Block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g), once a day
干预措施: Stellate Ganglion Block (Procedure)
Stellate Ganglion Block Group
Stellate Ganglion Block Group will be given Stellate Ganglion Block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g), once a day
干预措施: Lidocaine Hydrochloride (Drug)
结局指标
主要结局
Pittsburgh Sleep Quality Index
时间窗: day 1 and day 10
Pittsburgh Sleep Quality Index (PSQI): The PSQI is a widely used scale that assesses sleep quality, including aspects such as sleep latency, sleep duration, sleep efficiency, sleep disturbances, and daytime dysfunction. The total score ranges from 0 to 21, with higher scores indicating worse sleep quality.
次要结局
- Sleep Impairment Index(day 1 and day 10)
- Anxiety(day 1 and day 10)
研究者
Zeng Changhao
Research Director
People's Hospital of Zhengzhou University