The Effectiveness of Early Mobilisation on Back Pain in Patients Following Percutaneous Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Back Pain Intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Due to the nature of the intervention, participants and researchers cannot be blinded to the mobilisation intervention.
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 30-75 years Patients who have undergone PCI through the femoral artery Stable blood pressure and heart rate after PCI Femoral sheath has been removed No major complications after PCI Able to communicate clearly Have not received pain medication No other musculoskeletal problems Willing to participate in the study Willing to sign the informed consent form
排除标准
- •Unable or unwilling to complete the study PCI performed through the radial artery PCI performed through the brachial artery Chronic back pain before PCI Musculoskeletal problems that affect movement Severe bleeding after PCI Hematoma after PCI
研究组 & 干预措施
Early Mobilisation Group
Participants in this group will receive early mobilisation after Percutaneous Coronary Intervention (PCI). Early mobilisation includes gradual body movement and elevation of the head of the bed under nurse supervision to reduce back pain following the procedure.
干预措施: Early Mobilisation (Other)
Standard Care Group
Participants in this group will receive standard post-procedure care after Percutaneous Coronary Intervention (PCI), including routine bed rest according to hospital protocol.
干预措施: Standard Post-PCI Care (Other)
结局指标
主要结局
Back Pain Intensity
时间窗: Post-test: 4 hours after early mobilisation in the intervention group and 8 hours after femoral sheath removal in the control group
Back pain intensity measured using the Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
Back Pain Intensity
时间窗: 8 hours after Percutaneous Coronary Intervention (PCI)
Back pain intensity measured using the Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
次要结局
未报告次要终点
研究者
SANTISIHOMBING
Researcher
Universitas Sumatera Utara