The Effectiveness of Early Mobilisation on Back Pain in Patients Following Percutaneous Coronary Intervention
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Sumatra
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Medan, North Sumatra, Indonesia, 20231
- Murni Teguh Memorial Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
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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.
|
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Active Comparator: 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.
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Standard post-procedure care following Percutaneous Coronary Intervention (PCI), including routine bed rest according to hospital protocol without early mobilisation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Back Pain Intensity
Time Frame: Post-test: 4 hours after early mobilisation in the intervention group and 8 hours after femoral sheath removal in the control group
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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.
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Post-test: 4 hours after early mobilisation in the intervention group and 8 hours after femoral sheath removal in the control group
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sa Ranti Lina Sihombing, SKep.,Ners, Magister of Nursing, Faculty of Nursing ,North Of Sumatra university
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 140/KEPK/USU/2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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