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Идёт набор NCT07635446

Effects of Laura Mitchell's and Benson Relaxation Technique On Anxiety, Sleep Quality and Fatigue Among COPD Patients

Без фазы С лечением COPD

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: Laura Mitchell's Physiological Relaxation Technique., Benson Relaxation.
Кому может быть актуально
Состояния в реестре: COPD. Базовые параметры: 40 лет — 60 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
Пакистан
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Chronic Obstructive Pulmonary Disease (COPD) is a progressive lung condition characterized by persistent respiratory symptoms and airflow limitation. Patients with COPD often experience not only physical symptoms like breathlessness and fatigue but also psychological issues such as anxiety and poor sleep quality, which further compromise their quality of life. Non-pharmacological interventions, especially relaxation techniques, have shown promise in improving psychological well-being and physiological outcomes in COPD patients. Among these, Laura Mitchell's relaxation technique and Benson's relaxation response have gained attention for their simplicity and effectiveness. The primary objective of this study is to assess and compare the effects of Laura Mitchell's relaxation technique and Benson's relaxation technique on anxiety, sleep quality, and fatigue levels in patients diagnosed with moderate to severe COPD. By evaluating these parameters, the study aims to determine which method provides greater benefits in managing psychological and physical symptoms associated with COPD. The study will use a randomized experimental design. Participants will be randomly assigned into two groups: Group A will receive Laura Mitchell's relaxation training, and Group B will receive Benson's technique. Both interventions will be practiced daily for 15-20 minutes over a 6-weeks period. Baseline and post-intervention (week 6) data will be collected. Outcome measures will include anxiety (GAD-7), fatigue (FSS) and sleep quality (PSQI). Data will be analyzed using paired and independent t-tests to assess within-group and between-group differences, with significance set at p \< 0.05. The data will be analyzed using SPSS v 25.

Вмешательства

  • Поведенческое Laura Mitchell's Physiological Relaxation Technique.
    This technique involves awareness of postural alignment, controlled muscular tension-release, and slow rhythmic breathing. Participants will then be instructed to perform the technique daily for 15-20 minutes over a period of 6 weeks at home. Each participant will maintain a daily logbook recording the time, duration, and any feedback regarding their practice.
  • Поведенческое Benson Relaxation
    The session will include instruction on deep breathing, mental repetition of a calming word or phrase (e.g., "relax" or "one"), and passive redirection of attention away from distracting thoughts. Participants will then practice the technique daily for 15-20 minutes for 6 weeks in a quiet environment. Each participant will also maintain a daily practice logbook.

Первичные конечные точки

  • Change in Anxiety Severity Assessed by the Generalized Anxiety Disorder-7 [Срок оценки: 6 week]
  • Pitts burg Sleep Quality index [Срок оценки: 6 week]
Вторичные конечные точки (1)
  • Change in Fatigue Severity Assessed by the Fatigue Severity Scale [Срок оценки: 6 week]

Критерии участия

Критерии включения

\- Gender: Male and Female

  • Age: 40 to 60 years
  • Patients diagnosed with COPD
  • Willing to participate

Критерии исключения

  • Patients with Exacerbations within past 4 weeks
  • Cardiac Diseases (Acute MI, Congestive Heart Failure)
  • Neuromuscular Disorder
  • Recent lung diseases
  • Hemodynamic instability
  • Respiratory failure

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Пакистан · 1 центр
  • Gulab Devi Hospital — Lahore

Идентификаторы

NCT: NCT07635446 · REC/RCR & AHS/25/0308

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗