Determining the Effects of Reflexology and Cold Application Before Chest Tube Removal on Pain, Anxiety, and Physiological Parameters in Patients Undergoing Coronary Artery Bypass Grafting: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Severity of Post-Procedural Pain
研究概览
简要总结
This study aims to evaluate the effects of combined reflexology and cold application on pain, anxiety, and physiological parameters in patients undergoing chest tube removal (CTR) after coronary artery bypass grafting (CABG) surgery. Chest tube removal is an invasive procedure that often causes significant pain and anxiety, which can negatively impact the recovery process. In this randomized controlled trial, patients will be assigned to a combined intervention group (reflexology and cold application) or a control group. The study seeks to provide evidence-based recommendations for non-pharmacological nursing interventions to improve patient comfort and reduce complications during the post-operative period.
详细描述
This randomized, controlled, experimental study will be conducted with patients undergoing chest tube removal after CABG at the Gulhane Training and Research Hospital Cardiovascular Surgery Intensive Care Unit. Based on power analysis, a minimum of 108 patients will be enrolled and randomly assigned to three groups (1:1:1 ratio) using block randomization:
Combined Intervention Group: Patients will receive foot reflexology for 40 minutes (20 minutes per foot) and cold application (at -20°C/-30°C using a 13x13 cm cold pack applied over gauze for 20 minutes) immediately before chest tube removal.
Control Group: Patients will receive standard clinical care without additional interventions but will be monitored for their experiences and questions.
Data Collection:
Data will be collected using a Patient Identification Form, a Visual Analog Scale (VAS) for pain, the State-Trait Anxiety Inventory (STAI) for anxiety, and a Vital Signs Follow-up Form for physiological parameters (Blood Pressure, Heart Rate, Respiratory Rate, and Oxygen Saturation).
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 interventions (foot reflexology and cold application), masking of participants and investigators was not possible. However, the data will be analyzed objectively.
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
- •Being 18 years of age or older
- •Not having undergone previous open heart surgery
- •Not having received analgesics within 4 hours prior to the procedure
- •Having a VAS pain score of 3 or higher
- •Voluntary participation in the study
排除标准
- •Being under 18 years of age
- •Using inotropic drugs
- •Having a history of chronic pain
- •Having a history of alcohol or drug use
- •Having a psychiatric illness
- •Having skin lesions, burns, or wounds on the feet that would prevent massage application
研究组 & 干预措施
Reflexology Group
Patients in this group will receive foot reflexology for 40 minutes (20 minutes for each foot) before chest tube removal.
干预措施: Reflexology (Behavioral)
Cold Application Group
Patients in this group will receive cold application using a cold pack (13x13 cm) at the tube site for 20 minutes before chest tube removal.
干预措施: Cryotherapy alone (Behavioral)
Control Group
Patients in this group will receive standard clinical care and monitoring, with no additional interventions.
结局指标
主要结局
Severity of Post-Procedural Pain
时间窗: Baseline (T1: initial), pre-procedure after intervention (T2: 40 minutes after initial), and 30 minutes post-procedure (T3).
Pain severity will be measured using a Visual Analog Scale (VAS), where 0 represents 'no pain' and 10 represents 'the most severe pain imaginable.' Higher scores indicate greater pain intensity.
次要结局
- State Anxiety Level(30 minutes post-procedure (T3).)
- Physiological Parameters (Systolic Blood Pressure)(Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).)
- Physiological Parameters (Diastolic Blood Pressure)(Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).)
- Physiological Parameters (Heart Rate)(Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).)
- Respiratory Rate(Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).)
- Oxygen Saturation (SpO2) (%)(Baseline (T1), pre-procedure (T2), and 30 minutes post-procedure (T3).)
研究者
Neriman Yükseltürk Simşek
assistant prof
Ankara University