Peripheral Arterial Disease
Conditions
Brief 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.
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.
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.
Sponsors
Kufa University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Not applicable; all participants, care providers, and investigators were aware of group assignments.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity after diaphragmatic deep breathing exercises | 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
| Measure | Time frame | Description |
|---|---|---|
| systolic BP | Before exercise, immediately after exercise, and one hour post-exercise | Systolic blood pressure measured in mmHg to evaluate cardiovascular response following diaphragmatic breathing exercises. |
| Diastolic Blood Pressure | Before exercise, immediately after exercise, and one hour post-exercise | Diastolic blood pressure measured in mmHg to evaluate cardiovascular stability following diaphragmatic breathing exercises. |
| Heart Rate | 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. |
| Oxygen Saturation (SpO2) | 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. |
Countries
Iraq
Outcome results
None listed