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Набор скоро начнётся NCT07731282

Benson Relaxation for Anxiety and Depression After Stroke

Без фазы С лечением Ischemic Stroke, Acute Post-stroke Anxiety Post-stroke Depression

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Benson Relaxation Technique, Structured Health Education.
Кому может быть актуально
Состояния в реестре: Ischemic Stroke, Acute, Post-stroke Anxiety, Post-stroke Depression. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

Short-term Effects of Benson Relaxation Technique on Anxiety, Depression, and Prefrontal Cortical Function in Patients With Acute Ischemic Stroke: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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).

Вмешательства

  • Поведенческое Benson Relaxation Technique
    A 20-minute mind-body relaxation session including environment preparation, breathing regulation, systematic muscle relaxation, and guided imagery, delivered twice daily for 14 days by trained nurses at the bedside.
  • Поведенческое Structured Health Education
    A 20-minute structured health education session covering stroke rehabilitation knowledge, diet guidance, medication adherence, and emotional management, delivered twice daily for 14 days by nurses at the bedside, matched in frequency and duration to the BRT group.

Первичные конечные точки

  • Hospital Anxiety and Depression Scale (HADS) - Anxiety and Depression Subscales [Срок оценки: Baseline (T0, within 24 hours of enrollment) and post-intervention (T1, day 14 ± 1 day)]
Вторичные конечные точки (3)
  • Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: T0 and T1 (day 14)]
  • Stroke-Specific Quality of Life Scale (SS-QOL) [Срок оценки: T0 and T1 (day 14)]
  • Functional near-infrared spectroscopy (fNIRS) [Срок оценки: T0 and T1 (day 14)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Changchun University of Traditional Chinese Medicine — Changchun

Идентификаторы

NCT: NCT07731282 · BRT-Stroke-2026-CCUCM

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗