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Набор скоро начнётся NCT07475273

The Effectiveness of Early Mobilisation on Back Pain in Patients Following Percutaneous Coronary Intervention

Без фазы С лечением Back Pain Coronary Artery Disease Percutaneous Coronary Intervention

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: Early Mobilisation, Standard Post-PCI Care.
Кому может быть актуально
Состояния в реестре: Back Pain Coronary Artery Disease Percutaneous Coronary Intervention. Базовые параметры: 30 лет — 75 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
Индонезия
Следующий шаг
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Обзор

Percutaneous Coronary Intervention (PCI) is a common revascularization procedure for patients with coronary artery disease. Patients undergoing PCI are often required to remain in a supine position for several hours after the procedure to prevent complications at the vascular access site. Prolonged immobilization can lead to discomfort and back pain. Early mobilisation may help reduce back pain and improve patient comfort without increasing the risk of complications. This study aims to evaluate the effectiveness of early mobilisation in reducing back pain among patients following Percutaneous Coronary Intervention.

Подробное описание

Percutaneous Coronary Intervention (PCI) is widely performed to restore coronary blood flow in patients with coronary artery disease. After PCI, patients are commonly instructed to remain in a supine position for extended periods to reduce the risk of bleeding at the catheter insertion site. However, prolonged bed rest has been associated with several adverse effects, including lower back pain, discomfort, and reduced patient satisfaction.

Early mobilisation has been proposed as a strategy to reduce these complications while maintaining patient safety. Several studies suggest that allowing patients to mobilise earlier may reduce back pain and improve overall comfort without increasing vascular complications.

This interventional study aims to determine the effectiveness of early mobilisation in reducing back pain among patients following PCI. Participants will be divided into two groups: an intervention group receiving early mobilisation and a control group receiving standard post-PCI care. Back pain intensity will be measured using a validated pain scale at specific time intervals following the procedure.

The findings of this study are expected to provide evidence to support improved nursing care protocols and enhance patient comfort during post-PCI recovery.

Вмешательства

  • Другое Early Mobilisation
    Early mobilisation includes gradual mobilisation such as head-of-bed elevation and controlled body movement initiated earlier after Percutaneous Coronary Intervention (PCI) under nurse supervision to reduce back pain.
  • Другое Standard Post-PCI Care
    Standard post-procedure care following Percutaneous Coronary Intervention (PCI), including routine bed rest according to hospital protocol without early mobilisation.

Первичные конечные точки

  • Back Pain Intensity [Срок оценки: 8 hours after Percutaneous Coronary Intervention (PCI)]

Критерии участия

Критерии включения

  • Patients diagnosed with coronary artery disease undergoing Percutaneous Coronary Intervention, Age between 30 and 75 years, Hemodynamically stable after PCI, Able to communicate and provide informed consent

Критерии исключения

  • Patients with complications following PCI (e.g., bleeding or hemodynamic instability), Patients with chronic back pain or spinal disorders, Patients with mobility limitations or neurological disorders, Patients who are unable to communicate pain levels.

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

Индонезия · 1 центр
  • Murni Teguh Memorial Hospital — Medan

Идентификаторы

NCT: NCT07475273 · 140/KEPK/USU/2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗