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

NCT07475273 | Not Yet Recruiting

• 1 other identifier: 140/KEPK/USU/2026
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain Coronary Artery Disease Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  8 hours after Percutaneous Coronary Intervention (PCI)

Study Arms (2)

Early Mobilisation Group

EXPERIMENTAL

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

Standard Care Group

ACTIVE COMPARATOR

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

Interventions

Early Mobilisation OTHER

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.

Early Mobilisation Group

Standard Post-PCI Care OTHER

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

Standard Care Group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Sumatera Utara: lead

Study Sites (1)

Murni Teguh Memorial Hospital

Medan, North Sumatra, 20231, Indonesia

Location

Study Officials

• Sa Ranti Lina Sihombing, SKep.,Ners

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Santi Ranti Lina Sihombing, S.Kep., Ners

CONTACT

+6281396401349; sihombingsanti187@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Due to the nature of the intervention, participants and researchers cannot be blinded to the mobilisation intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

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

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)