An interventional study of Early Mobilisation and Standard Post-PCI Care in Coronary Artery Disease, sponsored by Universitas Sumatera Utara. Completed at 1 site in Indonesia. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Universitas Sumatera Utara · Not applicable, Interventional, and Treatment
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.
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.
5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.
This study's enrollment of 66 is below the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Universitas Sumatera Utara is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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
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.
Other: Early Mobilisation
Participants in this group will receive standard post-procedure care after Percutaneous Coronary Intervention (PCI), including routine bed rest according to hospital protocol.
Other: Standard Post-PCI Care
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.
Standard post-procedure care following Percutaneous Coronary Intervention (PCI), including routine bed rest according to hospital protocol without early mobilisation.
Back Pain Intensity
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.
Time frame: Post-test: 4 hours after early mobilisation in the intervention group and 8 hours after femoral sheath removal in the control group
Plan to share: No — Individual participant data (IPD) will not be shared due to patient confidentiality and institutional data protection policies.
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Universitas Sumatera Utara