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

Universitas Sumatera Utara

Status: Not yet enrolling

Conditions: Back Pain Coronary Artery Disease Percutaneous Coronary Intervention

Treatments: Other: Standard Post-PCI Care; Other: Early Mobilisation

Study type: Interventional

Funder types: Other

Identifiers

NCT07475273

140/KEPK/USU/2026

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Early Mobilisation Group

Experimental group

Description:

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.

Treatment:

Other: Early Mobilisation

Standard Care Group

Active Comparator group

Description:

Participants in this group will receive standard post-procedure care after Percutaneous Coronary Intervention (PCI), including routine bed rest according to hospital protocol.

Treatment:

Other: Standard Post-PCI Care