Effect of The Foot Reflexology Applied Before Chest Tube Removal on the Pain And Anxiety Level: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Numeric Pain Rating Scale Change
研究概览
简要总结
In open heart surgeries, patients experience severe pain due to tissue trauma, damage to intercostal nerves, and muscle spasm due to pulling tubes from the mediastinal space and between the pleural leaves pull during chet tube removal (CTR). When acute pain is not relieved, the patient develops emotional, psychological (eg post-traumatic stress disorder) and physical problems (eg chronic pain) after surgery. Since this situation negatively affects the healing process, it increases the anxiety level of the patients and decreases the comfort level. Reflexology is one of the non-pharmacological methods used in the management of pain and anxiety after open heart surgery The aim of this randomized controlled study was to identify the effect of foot reflexology applied before chest tube removal process on pain and anxiety level. This study will be done a randomized-controlled trial to test the intervention.
详细描述
Background: Patients undergoing cardiovascular surgery suffer from anxiety and pain due to the chest tube removal (CTR).
Objective/Hypothesis: The aim of this randomized controlled study was to identify the effect of foot reflexology applied before chest tube removal process on pain and anxiety level.The following hypotheses (H) were tested in this study:
H1a : There was a difference between the reflexology group and the control group in terms of pain level during CTR.
H1b : There was a difference between the reflexology group and the control group in terms of anxiety level during CTR.
H1c : There was a difference between the reflexology group and the control group in terms of the difference between the pain level before CTR and during CTR.
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
Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients over 18 years who have CABG surgery
- •Having at least two chest tube catheters
- •Having chest tubes removed together
- •Volunteering to participate in the research
排除标准
- •Patients with diagnosed with psychiatric illness
- •Having orientation or confusion problems, complete vision or hearing loss, mental problems due to problems such as dementia, mental retardation, and language problems
- •Having pacemaker, varicose veins in the ankles
- •Having chronic pain
- •Having femoral fracture and open wound on the sole of the foot
- •Having acute infection and hyperthermia, thromboembolism, suspected deep vein thrombosis at the postoperatively
结局指标
主要结局
Numeric Pain Rating Scale Change
时间窗: 1st postoperative day change from baseline pain score at after intervention, 2nd postoperative day change from baseline pain score at during, 15th min,1h after chest tube removal
Numeric Pain Rating Scale includes values ranging from 0 (no pain) - 10 (the worst pain)
Profile of Mood States Scale Tension-Anxiety Subscale Change
时间窗: 1st postoperative day change from baseline pain score at after intervention, 2nd postoperative day change from baseline pain score at during, 15th min after chest tube removal
Profile of Mood States Scale Tension-Anxiety Subscale includes the following nine items: tense, shaky, on edge, panicky, uneasy, restless, nervous and anxious. Each item was graded as 0 (not at all), 1 (a little), 2 (moderately), 3 (quite a bit) or 4 (extremely) and the sum of the items is the total scale, varying from 0 (no tension-anxiety) - 36 (most tension-anxiety).
次要结局
- Numerical Satisfaction Evaluation Form(Second postoperative day)
- Form to determine the feelings and thoughts of the patients about reflexology application and chest tube removal(Second postoperative day)
研究者
Elif BUDAK ERTÜRK
Principal Investigator, Assistant Professor
Baskent University