The Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography on Pain, Anxiety, Patient Satisfaction, and Hemodynamic Parameters
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
This randomized controlled trial aims to evaluate the effects of stress ball use during femoral arterial sheath removal after coronary angiography on pain, anxiety, patient satisfaction, and hemodynamic parameters. A total of 34 patients will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will use a stress ball during femoral arterial sheath removal in addition to routine care, while participants in the control group will receive routine care only. Pain, anxiety, patient satisfaction, and hemodynamic parameters will be assessed before and at specified time points after femoral arterial sheath removal.
详细描述
Coronary angiography is a commonly used invasive procedure for the diagnosis and treatment of coronary artery disease. Following coronary angiography performed via the femoral artery, removal of the femoral arterial sheath may cause pain and anxiety and may lead to changes in hemodynamic parameters. Therefore, simple, safe, and nonpharmacological nursing interventions that can improve patient comfort during femoral arterial sheath removal are important.
This prospective, two-arm, randomized controlled trial aims to evaluate the effects of stress ball use during femoral arterial sheath removal after coronary angiography on pain, anxiety, patient satisfaction, and hemodynamic parameters. The study will include 34 patients who meet the eligibility criteria. Participants will be randomly assigned in a 1:1 ratio to either the stress ball intervention group (n=17) or the control group (n=17) using block randomization.
Participants assigned to the intervention group will receive a stress ball immediately before femoral arterial sheath removal. A round, medium-firm silicone stress ball approximately 6 cm in diameter will be used. Participants will be instructed to hold the stress ball in their hand and rhythmically squeeze and release it after counting to three. The intervention will begin approximately one minute before femoral arterial sheath removal and will continue during and after sheath removal for a total of 10 minutes. Participants in the control group will receive routine clinical care without any additional nonpharmacological intervention.
Pain intensity will be assessed using the Visual Analog Scale (VAS), anxiety using the Visual Analog Scale for Anxiety (VAS-A), and patient satisfaction using the Visual Analog Scale for Patient Satisfaction (VAS-PS). Hemodynamic parameters will include systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation (SpO2).
Assessments will be performed at five predefined time points: immediately before femoral arterial sheath removal (T0), immediately after sheath removal (T1), and at 5 minutes (T2), 15 minutes (T3), and 30 minutes (T4) after the procedure. Routine medical treatment and nursing care will be continued for participants in both groups throughout the study.
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
Due to the nature of the intervention, participants and the researcher administering the intervention cannot be blinded. Data will be coded as Group A and Group B, and the statistical analysis will be performed by an independent statistician who is blinded to group allocation.
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
- •Patients who underwent coronary angiography via the femoral artery and received stent implantation or balloon angioplasty
- •Aged 18 years or older
- •Willing to participate in the study and providing written informed consent
- •Conscious, oriented, and cooperative
- •Able to read and understand Turkish
- •No hearing or visual impairment that would interfere with participation
- •Clinically and hemodynamically stable
- •No diagnosed psychiatric disorder
排除标准
- •Coronary angiography performed via the radial artery
- •Development of a complication during coronary angiography, such as arrhythmia
- •Administration of sedation during coronary angiography
- •Pregnancy
- •Prisoners or other vulnerable individuals
研究组 & 干预措施
Stress Ball Group
Participants in this group will use a stress ball in addition to routine care. The stress ball intervention will begin approximately one minute before femoral arterial sheath removal and will continue during and after sheath removal for a total of 10 minutes.
干预措施: Stress Ball (Behavioral)
Control Group
Participants in this group will receive routine care only, without any additional nonpharmacological intervention.
结局指标
主要结局
Pain Intensity
时间窗: Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity.
次要结局
- Anxiety Level(Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.)
- Patient Satisfaction(Immediately before femoral arterial sheath removal and 30 minutes after removal.)
- Systolic Blood Pressure(Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.)
- Diastolic Blood Pressure(Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.)
- Heart Rate(Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.)
- Respiratory Rate(Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.)
- Peripheral Oxygen Saturation(Immediately before femoral arterial sheath removal, immediately after removal, and 5, 15, and 30 minutes after removal.)
研究者
Tugba CAM YANIK
Assistant Professor of Surgical Diseases Nursing
Mersin University