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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 (SpOâ‚‚) are measured before, immediately after, and one hour post-exercise. |
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| 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, SpOâ‚‚) are measured at the same time points as the intervention group for comparison. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Najaf Center for Cardiac Surgery and Cardiac Catheterisation , Najaf Health Directorate | Najaf | Iraq |
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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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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Participants were randomly assigned to either the intervention group performing diaphragmatic deep breathing exercises or the control group receiving standard post-PTA care.
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Not applicable; all participants, care providers, and investigators were aware of group assignments.
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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 |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |