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

Effectiveness of Deep Breathing Exercise on Pain and Hemodynamic Parameters in Patients After Peripheral Percutaneous Transluminal Angioplasty: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Behavioral: Diaphragmatic Deep Breathing Exercise

Detailed Description

This study is a randomized controlled trial designed to assess the effectiveness of diaphragmatic deep breathing exercises on pain intensity and hemodynamic parameters in adult patients following peripheral percutaneous transluminal angioplasty (PTA). Eligible participants were randomly assigned to either the intervention group, which performed structured diaphragmatic breathing exercises, or the control group, which received standard post-PTA care.

Pain intensity was measured using the Numeric Rating Scale (NRS) before, immediately after, and one hour following the exercises. Hemodynamic parameters-including heart rate, systolic and diastolic blood pressure, and oxygen saturation-were recorded at the same time points. Socio-demographic and clinical data were collected to examine potential associations with the participants' responses to the intervention.

The study aims to determine whether diaphragmatic deep breathing exercises can effectively reduce post-PTA pain and support hemodynamic stability, offering a non-pharmacological approach to improve patient comfort and recovery outcomes.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group - Diaphragmatic Deep Breathing Exercises.; 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; 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.
No Intervention: Control Group - Standard Post-PTA Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
systolic BP	Systolic blood pressure measured in mmHg to evaluate cardiovascular response following diaphragmatic breathing exercises.	Before exercise, immediately after exercise, and one hour post-exercise
Diastolic Blood Pressure	Diastolic blood pressure measured in mmHg to evaluate cardiovascular stability following diaphragmatic breathing exercises.	Before exercise, immediately after exercise, and one hour post-exercise
Heart Rate	Heart rate measured in beats per minute to assess the hemodynamic response to diaphragmatic breathing exercises following peripheral PTA.	Before exercise, immediately after exercise, and one hour post-exercise
Oxygen Saturation (SpO2)	Peripheral oxygen saturation measured using pulse oximetry to assess oxygenation status after diaphragmatic breathing exercises.	Before exercise, immediately after exercise, and one hour post-exercise

Collaborators and Investigators

• Sponsor: Kufa University

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2025
• Primary Completion (Actual): January 25, 2026
• Study Completion (Actual): January 25, 2026

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 7, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: UOK-NUR-45821

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 to protect patient privacy and confidentiality. The study involves sensitive health information, and data sharing is restricted in accordance with institutional regulations and ethical approvals. Aggregate study results will be published without disclosing any identifiable participant information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No