The Effect of Acupuncture Treatment on Sleep Quality in Post-Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Pittsburgh Sleep Quality Index
研究概览
简要总结
The aim of this study is to investigate the effectiveness and reliability of acupuncture treatment in patients experiencing impaired sleep quality after a stroke. Additionally, the goal is to reduce the need for multiple medications and/or high-dose drug usage in the treatment of these complications in patients
详细描述
The aim of this study is to evaluate the effect of acupuncture therapy on sleep quality in patients experiencing insomnia in the early post-stroke period. In this prospective, randomized controlled, single-blind study, 70 ischemic stroke patients undergoing inpatient rehabilitation were included. Participants were randomly divided into two groups: the acupuncture group receiving acupuncture therapy and standard rehabilitation program. The control group receiving only the standard rehabilitation program. The acupuncture group received acupuncture treatment twice a week for 4 weeks. Sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI). The PSQI scores were assessed three times at baseline, at the 4th week, and at the 8th week. The results of the study indicated that the acupuncture group demonstrated a significant improvement in sleep quality compared to the control group. Significant differences were observed between the baseline PSQI scores and the PSQI scores at the 4th week in both the acupuncture and control groups (p: 0.000 and p: 0.008). The change between baseline and 8th-week PSQI scores was also significant (p: 0.000 and p: 0.000). However, in the acupuncture group, the decrease in PSQI scores was significantly greater compared to the control group. The addition of acupuncture therapy to standard treatment resulted in a significant improvement in sleep quality. Additionally, the baseline PSQI scores were found to be correlated with the severity of depression.This study suggests that acupuncture therapy can be an effective intervention for improving sleep quality in patients with early post-stroke insomnia.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being between 18-80 years of age,
- •having a minimum of 2 and a maximum of 6 months elapsed since the ischemic stroke, -volunteering to participate in the study,
- •having a mini-mental test score above 17.
排除标准
- •history of insomnia or depression before stroke,
- •psychiatric medication use,
- •psychiatric illness, aphasia, sleep apnea syndrome,
- •decompensated cardiac, renal, or hepatic insufficiency, pregnancy,
- •presence of infection in the areas where acupuncture would be applied.
研究组 & 干预措施
Acupuncture group
The patients who received acupuncture treatment in addition to a standard rehabilitation program
干预措施: Acupuncture treatment (Other)
Control group
The patients who received the standard rehabilitation program.
结局指标
主要结局
Pittsburgh Sleep Quality Index
时间窗: 0 day, 4th week and 8th week
The index helps to evaluate sleep quality of patient. The scores range from 0 to 21 and the authors suggest that a score \>5 be considered as a significant sleep disturbance.
次要结局
- Hamilton Depression Rating Scale(0 day, 4th week and 8th week)
- Hamilton Anxiety Rating Scale(0 day, 4th week and 8th week)
- Mini-Mental State Examination(0 day)
- Barthel Index(0 day)