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

March 11, 2026 updated by: SANTISIHOMBING, Universitas Sumatera Utara

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

Not yet recruiting

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

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
    • North Sumatra
      • Medan, North Sumatra, Indonesia, 20231
        • Murni Teguh Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Santi Ranti Lina Sihombing, SKep.,Ners

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Back Pain Intensity
Time Frame: 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.
8 hours after Percutaneous Coronary Intervention (PCI)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Sumatera Utara

Investigators

  • Principal Investigator: Sa Ranti Lina Sihombing, SKep.,Ners, Magister of Nursing, Faculty of Nursing ,North Of Sumatra university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2026

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 140/KEPK/USU/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to patient confidentiality and institutional data protection policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Back Pain Coronary Artery Disease Percutaneous Coronary Intervention

Clinical Trials on Early Mobilisation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe