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NCT Number: NCT07464990

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Najaf, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Pain intensity after diaphragmatic deep breathing exercises

    Time frame: Before exercise, immediately after exercise, and one hour post-exercise

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

Secondary outcomes

  1. systolic BP

    Time frame: Before exercise, immediately after exercise, and one hour post-exercise

    Systolic blood pressure measured in mmHg to evaluate cardiovascular response following diaphragmatic breathing exercises.

  2. Diastolic Blood Pressure

    Time frame: Before exercise, immediately after exercise, and one hour post-exercise

    Diastolic blood pressure measured in mmHg to evaluate cardiovascular stability following diaphragmatic breathing exercises.

  3. Heart Rate

    Time frame: Before exercise, immediately after exercise, and one hour post-exercise

    Heart rate measured in beats per minute to assess the hemodynamic response to diaphragmatic breathing exercises following peripheral PTA.

  4. Oxygen Saturation (SpO2)

    Time frame: Before exercise, immediately after exercise, and one hour post-exercise

    Peripheral oxygen saturation measured using pulse oximetry to assess oxygenation status after diaphragmatic breathing exercises.

Sponsors and collaborators

Lead sponsor

Kufa University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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