Peripheral Arterial DiseaseNCT07464990
Deep Breathing Exercise for Pain and Hemodynamic Stability in Patients After Peripheral Percutaneous Angioplasty
A study testing Diaphragmatic Deep Breathing Exercise in people with Peripheral Arterial Disease, run by Kufa University at 1 site in Iraq.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Diaphragmatic Deep Breathing Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIraq
- Study dates
- 25 Nov 2025to 25 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Najaf Center for Cardiac Surgery and Cardiac Catheterisation , Najaf Health Directorate
Najaf
About this study
Official title: 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.
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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Diaphragmatic Deep Breathing Exercise
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragmatic Deep Breathing ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Before exercise, immediately after exercise, and one hour post-exercise
Secondary outcomes (4)
systolic BP
Systolic blood pressure measured in mmHg to evaluate cardiovascular response following diaphragmatic breathing exercises.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before exercise, immediately after exercise, and one hour post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start25 Nov 2025
- Primary completion25 Jan 2026
- Study completion25 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to either the intervention group performing diaphragmatic deep breathing exercises or the control group receiving standard post-PTA care.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kufa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ABBAS JABBAR HASAN ALTUFAILI, Kufa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464990
- Sponsor's protocol ID
- UOK-NUR-45821
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Deep Breathing Exercise on Pain and Hemodynamic Parameters in Patients After Peripheral Percutaneous Transluminal Angioplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07464990
- Acronym / sponsor ID
- UOK-NUR-45821
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kufa UniversityUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 25 Jan 2026 (actual)
- Study completion
- 25 Jan 2026 (actual)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either the intervention group performing diaphragmatic deep breathing exercises or the control group receiving standard post-PTA care.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - Diaphragmatic Deep Breathing Exercises. | Experimental | Behavioral: Diaphragmatic Deep Breathing ExercisePatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragmatic Deep Breathing ExerciseParticipants 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. | Behavioural | Intervention Group - Diaphragmatic Deep Breathing Exercises. |
Primary outcome
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).
4 secondary outcomes
systolic BP
Time frame: Before exercise, immediately after exercise, and one hour post-exercise
Diastolic Blood Pressure
Time frame: Before exercise, immediately after exercise, and one hour post-exercise
Heart Rate
Time frame: Before exercise, immediately after exercise, and one hour post-exercise
Oxygen Saturation (SpO2)
Time frame: Before exercise, immediately after exercise, and one hour post-exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragmatic Deep Breathing Exercise in people with Peripheral Arterial Disease, run by Kufa University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity after diaphragmatic deep breathing exercises (time frame: Before exercise, immediately after exercise, and one hour post-exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.