Effects of the Benson Relaxation Technique on Anxiety, Depression, Sleep Quality 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
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 3
- 主要终点
- Hospital Anxiety and Depression Scale (HADS) - Anxiety and Depression Subscales
研究概览
简要总结
Stroke is a leading cause of disability worldwide. Many patients experience anxiety, depression, and sleep disturbances 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 multicenter, 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 84 participants will be randomly assigned (1:1) to either the BRT group or a structured health education active 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). Assuming a 10-12% dropout rate, approximately 10 participants will withdraw, leaving 74 participants (37 per group) to complete the study and be included in the final analysis. The primary outcomes are the Hospital Anxiety and Depression Scale (HADS-A and HADS-D) and the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes include the Stroke-Specific Quality of Life Scale (SS-QOL) and resting-state functional near-infrared spectroscopy (fNIRS) metrics.
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)
- •Age ≥ 18 years old
- •Clear consciousness, stable condition, and able to communicate effectively
- •Hospital Anxiety and Depression Scale (HADS) score: HADS-A ≥ 8 points or HADS-D ≥ 8 points (or both ≥ 8 points)
- •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
- •Has a clear history of mental illness or has been taking anti-psychotic drugs for a long time
- •Is currently participating in other clinical intervention studies
研究组 & 干预措施
BRT Group
Behavioral: Benson Relaxation Technique
干预措施: Benson Relaxation Technique (Behavioral)
Control Group
Behavioral: Structured Health Education
干预措施: Structured Health Education (Behavioral)
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). Scores range from 0 to 21, with higher scores indicating more severe anxiety or depression symptoms.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: T0 and T1 (day 14)
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality. The scale ranges from 0 to 21, with higher scores indicating worse sleep quality. The scale will be administered 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
Graduate Student Researcher
Changchun University of Traditional Chinese Medicine