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CompletedNCT07464990Updated Mar 11, 2026

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

An interventional study of Diaphragmatic Deep Breathing Exercise in Peripheral Arterial Disease, sponsored by Kufa University. Completed at 1 site in Iraq. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-11.

Sponsored by Kufa University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Nov 2025, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Peripheral Arterial Disease
03

In context

Peripheral Arterial Disease

1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.

This study's enrollment of 100 is above the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Kufa University is the lead sponsor of 14 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • BehavioralDiaphragmatic 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.

06

What researchers measure

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).

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

Secondary outcomes

  1. systolic BP

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

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

  2. Diastolic Blood Pressure

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

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

  3. Heart Rate

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

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

  4. Oxygen Saturation (SpO2)

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

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

07

Study locations

1 site
  • Najaf Center for Cardiac Surgery and Cardiac Catheterisation , Najaf Health Directorate
    Najaf, Iraq
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07464990
Lead sponsor
Kufa University
Responsible party
ABBAS JABBAR HASAN ALTUFAILI (Master's Student (Adult Nursing) / Principal Investigator, Kufa University) — Principal investigator
First posted
Mar 11, 2026
Start date
Nov 25, 2025
Primary completion
Jan 25, 2026
Completion
Jan 25, 2026
Last update
Mar 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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