The Effect of Stress Ball Use and Breathing Exercises on Procedural Pain and Vital Signs During Drain Removal After Total Knee Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 105
- 主要终点
- Pain Intensity (Numeric Rating Scale, NRS
研究概览
简要总结
This randomized controlled trial aims to evaluate the effects of stress ball use and breathing exercises on procedural pain and vital signs during drain removal in patients undergoing total knee arthroplasty. Although drain removal is a short procedure, it is often associated with sudden and intense pain and may trigger physiological stress responses such as increased heart rate, blood pressure, and respiratory rate.
A total of 105 patients will be randomly assigned to three groups: stress ball group, breathing exercise group, and standard care group. The interventions will be applied starting one minute before drain removal, continuing throughout the procedure, and for two minutes afterward.
Pain levels will be assessed using the Numeric Rating Scale (NRS), and vital signs (heart rate, blood pressure, respiratory rate, and oxygen saturation) will be measured at predefined time points before, during, and after the procedure. The findings of this study are expected to provide evidence on the effectiveness of simple, non-pharmacological interventions in reducing procedural pain and improving physiological stability during drain removal
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
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years and older undergoing primary total knee arthroplasty
- •Patients with a surgical drain in place and scheduled for drain removal in the postoperative period
- •Able to provide informed consent
- •Able to communicate and understand instructions
排除标准
- •Patients with chronic pain syndromes or regular opioid use
- •Patients with cognitive impairment, delirium, or communication difficulties
- •Patients with contraindications to drain removal (e.g., active bleeding, hemodynamic instability)
- •Patients with neurological conditions affecting pain perception
研究组 & 干预措施
Stress Ball Group
Patients use a stress ball during drain removal
干预措施: 1. Stress Ball Intervention Description (Behavioral)
Breathing Exercise Group
Patients perform breathing exercises during drain remo
干预措施: 2. Breathing Exercise Intervention Description (Behavioral)
Control Group
Patients receive standard care during drain removal.
干预措施: 3. Control Group Description (Behavioral)
结局指标
主要结局
Pain Intensity (Numeric Rating Scale, NRS
时间窗: Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
Pain intensity will be assessed using the Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates the worst possible pain. Pain levels will be recorded during and after drain removal.
Heart Rate
时间窗: Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
Heart rate (beats per minute) will be measured to assess physiological response to pain during drain removal.
Blood Pressure
时间窗: Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
Systolic and diastolic blood pressure (mmHg) will be measured to evaluate physiological stress response.
Oxygen Saturation
时间窗: Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
Peripheral oxygen saturation (%) will be measured using a pulse oximeter.
Respiratory Rate
时间窗: Baseline, immediately after drain removal, 15 minutes, and 30 minutes after the procedur
Respiratory rate (breaths per minute) will be recorded.
次要结局
未报告次要终点
研究者
HÜMEYRA YÜKSEL
Ph.D
TC Erciyes University