Effectiveness of Deep Breathing Exercise on Pain and Hemodynamic Parameters in Patients After Peripheral Percutaneous Transluminal Angioplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain intensity after diaphragmatic deep breathing exercises
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Not applicable; all participants, care providers, and investigators were aware of group assignments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Diaphragmatic Deep Breathing Exercise (Behavioral)
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.
结局指标
主要结局
Pain intensity after diaphragmatic deep breathing exercises
时间窗: 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).
次要结局
- systolic BP(Before exercise, immediately after exercise, and one hour post-exercise)
- Diastolic Blood Pressure(Before exercise, immediately after exercise, and one hour post-exercise)
- Heart Rate(Before exercise, immediately after exercise, and one hour post-exercise)
- Oxygen Saturation (SpO2)(Before exercise, immediately after exercise, and one hour post-exercise)
研究者
ABBAS JABBAR HASAN ALTUFAILI
Master's Student (Adult Nursing) / Principal Investigator
Kufa University