Short-term Effects of Benson Relaxation Technique on Anxiety, Depression, and Prefrontal Cortical Function in Patients With Acute Ischemic Stroke: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Hospital Anxiety and Depression Scale (HADS) - Anxiety and Depression Subscales
研究概览
简要总结
This study tests whether Benson Relaxation Technique (BRT), a simple mind-body relaxation method, can help reduce anxiety and depression in patients who had an ischemic stroke 7-14 days ago. Patients will be randomly assigned to either the BRT group (receiving 20-minute relaxation sessions twice daily for 2 weeks) or a control group (receiving health education sessions of the same duration). We will measure anxiety and depression using standard questionnaires, and use near-infrared brain imaging to see if BRT changes brain activity in the prefrontal cortex. The goal is to find a safe, non-drug way to improve mood in early stroke recovery.
详细描述
Stroke is a leading cause of disability worldwide. Many patients experience anxiety and depression in the early recovery phase, which can slow rehabilitation. Medications for mood symptoms may have side effects, especially in acute stroke patients. Benson Relaxation Technique (BRT) is a non-pharmacological mind-body intervention involving breathing exercises, muscle relaxation, and guided imagery. This single-center, assessor-blinded, randomized controlled trial aims to evaluate the short-term effects of BRT on anxiety, depression, sleep quality, quality of life, and prefrontal brain function in patients 7-14 days after ischemic stroke. A total of 74 participants will be randomly assigned to either the BRT group or a structured health education control group. Interventions will be delivered twice daily for 20 minutes over 14 days. Outcomes will be assessed at baseline (T0) and post-intervention (T1, day 14). Primary outcomes are anxiety and depression scores (HADS). Secondary outcomes include sleep quality (PSQI), stroke-specific quality of life (SS-QOL), and resting-state prefrontal functional connectivity measured by functional near-infrared spectroscopy (fNIRS).
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meets the diagnostic criteria for stroke set by the Neurology Branch of the Chinese Medical Association, and is confirmed as ischemic stroke based on CT or MRI examination results.
- •In the acute stage of stroke (7-14 days after onset) ③ Age ≥ 18 years old ④ Clear consciousness, stable condition, and able to communicate effectively ⑤ Hospital Anxiety and Depression Scale (HADS) score: HADS-A ≥ 8 points or HADS-D ≥ 8 points (or both ≥ 8 points) ⑥ Voluntarily participate in this study and sign the informed consent form.
排除标准
- •Combined with severe aphasia, visual and auditory impairments, unable to cooperate with intervention and assessment
- •Combined with severe dysfunction of organs such as the heart, liver, and kidneys or malignant tumors ③ Has a clear history of mental illness or has been taking anti-psychotic drugs for a long time ④ Is currently participating in other clinical intervention studies
结局指标
主要结局
Hospital Anxiety and Depression Scale (HADS) - Anxiety and Depression Subscales
时间窗: Baseline (T0, within 24 hours of enrollment) and post-intervention (T1, day 14 ± 1 day)
The Hospital Anxiety and Depression Scale (HADS) will be used to assess anxiety (HADS-A, 7 items, 0-21 points) and depression (HADS-D, 7 items, 0-21 points). A score ≥8 on either subscale indicates clinically significant symptoms. The scale will be administered by a blinded assessor at baseline (T0) and post-intervention (T1, day 14).
次要结局
- Stroke-Specific Quality of Life Scale (SS-QOL)(T0 and T1 (day 14))
- Functional near-infrared spectroscopy (fNIRS)(T0 and T1 (day 14))
- Pittsburgh Sleep Quality Index (PSQI)(T0 and T1 (day 14))
研究者
Geng Nannan
Changchun University of Traditional Chinese Medicine