Deep Breathing Exercise for Pain and Hemodynamic Stability in Patients After Peripheral Percutaneous Angioplasty

NCT07464990 | Completed

• 1 other identifier: UOK-NUR-45821
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial evaluates the effectiveness of diaphragmatic deep breathing exercises on pain and hemodynamic parameters in patients after peripheral percutaneous transluminal angioplasty (PTA). Participants were randomly assigned to an intervention group, which performed the breathing exercises, or a control group, which received standard post-PTA care. Pain levels and hemodynamic parameters, including heart rate, blood pressure, and oxygen saturation, were measured before and after the intervention. Socio-demographic and clinical characteristics were also collected to explore potential associations with patient responses. The purpose of this study is to determine whether diaphragmatic deep breathing can reduce post-PTA pain and support hemodynamic stability, thereby improving patient comfort and recovery outcomes.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Pain intensity after diaphragmatic deep breathing exercises

  Pain intensity measured using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain).

  Before exercise, immediately after exercise, and one hour post-exercise

Secondary Outcomes (4)

• systolic BP

  Before exercise, immediately after exercise, and one hour post-exercise

• Diastolic Blood Pressure

  Before exercise, immediately after exercise, and one hour post-exercise

• Heart Rate

  Before exercise, immediately after exercise, and one hour post-exercise

• Oxygen Saturation (SpO2)

  Before exercise, immediately after exercise, and one hour post-exercise

Study Arms (2)

Intervention Group - Diaphragmatic Deep Breathing Exercises.

EXPERIMENTAL

Patients perform structured diaphragmatic deep breathing exercises after peripheral PTA. Pain is assessed using the Numeric Rating Scale (NRS), and hemodynamic parameters including heart rate, systolic and diastolic blood pressure, and oxygen saturation (SpO₂) are measured before, immediately after, and one hour post-exercise.

Behavioral: Diaphragmatic Deep Breathing Exercise

Control Group - Standard Post-PTA Care

NO INTERVENTION

Patients receive routine post-PTA care without diaphragmatic breathing exercises. Pain and hemodynamic parameters (HR, SBP, DBP, SpO₂) are measured at the same time points as the intervention group for comparison.

Interventions

Diaphragmatic Deep Breathing Exercise BEHAVIORAL

Participants will perform guided diaphragmatic deep breathing exercises after peripheral percutaneous transluminal angioplasty (PTA). The technique involves slow deep inhalation through the nose with abdominal expansion followed by controlled exhalation through the mouth under researcher supervision. The intervention aims to reduce pain intensity and stabilize hemodynamic parameters.

Intervention Group - Diaphragmatic Deep Breathing Exercises.

Eligibility Criteria

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

You may qualify if:

• Aged 18 years and older.
• Patients diagnosed with peripheral arterial disease (PAD) and scheduled for peripheral percutaneous transluminal angioplasty (PTA).
• Patients able to communicate effectively and understand instructions.
• Patients who agree to participate and provide written informed consent.

You may not qualify if:

• Hemodynamically unstable patients
• Patients with psychiatric disorders or cognitive impairment affecting communication
• Pregnant patients
• Patients with severe respiratory diseases that interfere with breathing exercises
• Patients receiving opioid analgesics (e.g., pethidine) immediately after the procedure that may influence pain perception or hemodynamic parameters
• Patients with conditions affecting pain perception (e.g., diabetic peripheral neuropathy) or those receiving chronic analgesic therapy that may alter pain assessment.

Sponsors & Collaborators

• Kufa University: lead

Study Sites (1)

Najaf Center for Cardiac Surgery and Cardiac Catheterisation , Najaf Health Directorate

Najaf, Iraq

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable; all participants, care providers, and investigators were aware of group assignments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student (Adult Nursing) / Principal Investigator

Model Details: Participants were randomly assigned to either the intervention group performing diaphragmatic deep breathing exercises or the control group receiving standard post-PTA care.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 11, 2026
• Study Start: November 25, 2025
• Primary Completion: January 25, 2026
• Study Completion: January 25, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)