Life sciences · Interventional Study
ClinicalTrials.gov · September 29, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07731282). This is a study registration, not published results. Lead sponsor: Changchun University of Traditional Chinese Medicine. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 84 participants (ACTUAL). Conditions: Ischemic Stroke, Acute, Post-stroke Anxiety, Post-stroke Depression, Sleep. Interventions: BEHAVIORAL: Benson Relaxation Technique; BEHAVIORAL: Structured Health Education. Primary outcome measures: Hospital Anxiety and Depression Scale (HADS) - Anxiety and Depression Subscales , Baseline (T0, within 24 hours of enrollment) and post-intervention (T1, day 14 ± 1 day); Pittsburgh Sleep Quality Index (PSQI) , T0 and T1 (day 14). Brief summary: 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.