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Набор скоро начнётся NCT07542691

Respiratory Physiotherapy and PMR After Cardiac Surgery

Без фазы С лечением Cardiac Surgery Dyspnea Anxiety Delirium

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: Respiratory Physiotherapy, Progressive Muscle Relaxation, Routine Care.
Кому может быть актуально
Состояния в реестре: Cardiac Surgery, Dyspnea, Anxiety, Delirium. Базовые параметры: 18 лет — 80 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effect of Respiratory Physiotherapy and Progressive Muscle Relaxation Exercises on Dyspnea, Anxiety, Hemodynamic Status and Delirium Symptoms After Cardiac Surgery: A Randomized Controlled Trial

Обзор

This study aims to evaluate the effects of respiratory physiotherapy combined with progressive muscle relaxation exercises on dyspnea, anxiety, hemodynamic status, and delirium symptoms in patients after cardiac surgery. This randomized controlled trial will include 116 patients who will be randomly assigned to an intervention group or a control group. The intervention group will receive respiratory physiotherapy and progressive muscle relaxation exercises in addition to routine postoperative care for 30 minutes per day over three consecutive days, while the control group will receive routine care only. Outcome measures will include dyspnea assessed by the Modified Borg Scale, anxiety assessed by the State-Trait Anxiety Inventory, hemodynamic parameters obtained from vital signs, and delirium symptoms assessed using the Nursing Delirium Screening Scale. It is hypothesized that the combined intervention will reduce dyspnea and anxiety levels, improve hemodynamic stability, and decrease delirium symptoms. The findings are expected to contribute to improved postoperative recovery and reduced complication risks following cardiac surgery.

Подробное описание

This study is designed as a randomized controlled trial to investigate the effects of respiratory physiotherapy combined with progressive muscle relaxation exercises on dyspnea, anxiety, hemodynamic status, and delirium symptoms in patients following cardiac surgery. A total of 116 adult patients who have undergone cardiac surgery will be recruited and randomly allocated into two groups: an intervention group and a control group.

The intervention group will receive respiratory physiotherapy techniques, including breathing exercises, postural drainage, percussion, and vibration, together with progressive muscle relaxation exercises, in addition to routine postoperative care. These interventions will be applied for 30 minutes per day over three consecutive days in the postoperative period. The control group will receive only routine postoperative care and standard cardiac rehabilitation procedures.

Outcome measures will include dyspnea assessed using the Modified Borg Scale, anxiety assessed using the State-Trait Anxiety Inventory, hemodynamic parameters including blood pressure, heart rate, respiratory rate, and oxygen saturation obtained from routine vital sign monitoring, and delirium symptoms assessed using the Nursing Delirium Screening Scale. Data will be collected at baseline and after the intervention period.

Inclusion criteria include patients aged 18 years and older who have undergone cardiac surgery and are able to participate in the interventions. Patients with severe orthopedic limitations, communication barriers, or medical contraindications to the interventions will be excluded. Participants may withdraw from the study at any time, and all procedures will be conducted in accordance with ethical standards and patient safety principles.

Randomization will be performed using a computer-based randomization method, and participants will be assigned to groups in a 1:1 ratio. Statistical analysis will be conducted using appropriate parametric and non-parametric tests, with a significance level set at p \< 0.05.

Вмешательства

  • Другое Respiratory Physiotherapy
    Respiratory physiotherapy includes breathing exercises, postural drainage, percussion, and vibration techniques aimed at improving pulmonary function, facilitating secretion clearance, and enhancing oxygenation in postoperative cardiac surgery patients.
  • Другое Progressive Muscle Relaxation
    Progressive muscle relaxation is a systematic technique involving sequential contraction and relaxation of muscle groups combined with controlled breathing, aimed at reducing anxiety, improving psychological well-being, and promoting physiological relaxation.
  • Другое Routine Care
    Standard postoperative care and routine cardiac rehabilitation without additional respiratory physiotherapy or progressive muscle relaxation exercises.

Первичные конечные точки

  • Dyspnea (Modified Borg Scale) [Срок оценки: Within the first 24 hours after cardiac surgery (pre-intervention) and immediately after the intervention (post-intervention, same day)]

Критерии участия

Критерии включения

  • Patients aged 18-80 years who have undergone cardiac surgery
  • Hemodynamically stable patients
  • Patients able to cooperate and follow instructions
  • Patients with postoperative dyspnea
  • Patients who provide written informed consent

Критерии исключения

  • Patients with severe cognitive impairment or inability to cooperate
  • Patients with neurological or psychiatric disorders affecting participation
  • Patients requiring mechanical ventilation for prolonged periods
  • Patients with unstable hemodynamic status
  • Patients with contraindications to respiratory physiotherapy or exercise
  • Patients who refuse to participate

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
Простое слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07542691 · AYU-PT-2026-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗