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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07475273
Enrollment
66
Registered
2026-03-16
Start date
2026-03-30
Completion date
2026-06-30
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain Coronary Artery Disease Percutaneous Coronary Intervention

Brief summary

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.

Detailed 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.

Interventions

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.

OTHERStandard Post-PCI Care

Standard post-procedure care following Percutaneous Coronary Intervention (PCI), including routine bed rest according to hospital protocol without early mobilisation.

Sponsors

Universitas Sumatera Utara
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Due to the nature of the intervention, participants and researchers cannot be blinded to the mobilisation intervention.

Intervention model description

Participants will be randomly assigned to either the early mobilisation intervention group or the standard care control group.

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Back Pain Intensity8 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.

Countries

Indonesia

Contacts

CONTACTSanti Ranti Lina Sihombing, S.Kep., Ners
sihombingsanti187@gmail.com+6281396401349
PRINCIPAL_INVESTIGATORSa Ranti Lina Sihombing, SKep.,Ners

Magister of Nursing, Faculty of Nursing ,North Of Sumatra university

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026