The Effect of Box Breathing Before Chest Tube Removal After Open-Heart Surgery on Pain, Anxiety, Dyspnea, and Hemodynamic Parameters: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 86
- 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 box breathing performed before chest tube removal on pain, anxiety, dyspnea, and hemodynamic parameters in patients undergoing open-heart surgery. A total of 86 patients will be randomly assigned in a 1:1 ratio to either the box breathing group or the control group. Participants in the intervention group will perform the 4-4-4-4 box breathing technique for approximately five minutes before chest tube removal in addition to routine care, while participants in the control group will receive routine care only. Pain, anxiety, dyspnea, and hemodynamic parameters will be assessed before and at specified time points after chest tube removal.
详细描述
Chest tube removal is a routine procedure following open-heart surgery; however, it may cause pain, anxiety, dyspnea, and changes in hemodynamic parameters. Nonpharmacological interventions that are simple, safe, and easy to apply may contribute to symptom management during this procedure.
This prospective, two-arm, parallel-group randomized controlled trial will evaluate the effects of box breathing performed before chest tube removal in patients undergoing open-heart surgery. A total of 86 eligible patients will be randomly assigned in a 1:1 ratio to the intervention group (n=43) or control group (n=43) using block randomization.
Participants assigned to the intervention group will receive routine care and perform the box breathing technique approximately five minutes before chest tube removal. The technique consists of four phases of equal duration: inhaling for 4 seconds, holding the breath for 4 seconds, exhaling for 4 seconds, and holding after exhalation for 4 seconds. Participants will perform 15 consecutive cycles for approximately five minutes under the verbal guidance of the researcher. The exercise will be completed immediately before chest tube removal. Participants in the control group will receive routine clinical care without an 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 dyspnea using the Visual Analog Scale for Dyspnea (VAS-D). 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 time points: before the box breathing intervention (T0), immediately after chest tube removal (T1), and at 5 minutes (T2), 15 minutes (T3), and 30 minutes (T4) after chest tube removal. Both groups will continue to receive routine medical treatment and nursing care 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
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 have undergone open-heart surgery and have a chest tube
- •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
- •Clinically and hemodynamically stable
- •Having no more than three chest tubes (up to two mediastinal and one thoracic chest tube)
- •No diagnosed psychiatric disorder
- •Not receiving psychiatric medications and/or local neuromuscular blocking agents
排除标准
- •Patients who have not undergone open-heart surgery
- •Unconscious, disoriented, or uncooperative patients
- •Unable to read and understand Turkish
- •Intubated patients
- •Receiving additional analgesic medication other than routine analgesia
- •Receiving local anesthesia at the chest tube insertion site
- •Having four chest tubes (two mediastinal and two thoracic)
- •Unwilling to participate in the study
- •Having a diagnosed psychiatric disorder or mental health condition
研究组 & 干预措施
Control Group
Participants in this group will receive routine medical treatment and nursing care without any additional nonpharmacological intervention related to chest tube removal.
Box Breathing Group
Participants in this group will perform the box breathing technique in addition to routine care. Approximately five minutes before chest tube removal, participants will perform 15 cycles of the 4-4-4-4 box breathing technique, consisting of inhaling for 4 seconds, holding the breath for 4 seconds, exhaling for 4 seconds, and holding after exhalation for 4 seconds.
干预措施: Box breathing (Behavioral)
结局指标
主要结局
Pain Intensity
时间窗: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube 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(Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.)
- Dyspnea Level(Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.)
- Systolic Blood Pressure(Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.)
- Diastolic Blood Pressure(Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.)
- Heart Rate(Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.)
- Respiratory Rate(Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.)
- Peripheral Oxygen Saturation (SpO2)(Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.)
研究者
Tugba CAM YANIK
Assistant Professor of Surgical Diseases Nursing
Mersin University