The Effectiveness of Hand Massage on the Pain of Cardiac Surgery Critically Ill- A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- change in pain intensity from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale
研究概览
简要总结
Postoperative pain is a common phenomenon in the intensive care unit (ICU) despite the multitude of efforts dedicated to promote its effective relief. Mounting evidence shows that cardiac surgery ICU patients experience moderate to severe pain reaching proportions as high as 74% despite the use of analgesics. The highest pain intensity is experienced in the first 24 hours post surgery when patients are still in the ICU, and represents a strong predictor for the presence and severity of persistent postoperative pain. To maximize pain relief, massage has been suggested in the recent clinical practice guidelines of the Society of Critical-Care Medicine as a complementary non-pharmacological therapy in the ICU given its opioid-sparing and analgesia-enhancing potential. Some randomized controlled trials showed promising pain relief effects of massage when administered to cardiac surgery patients in acute care units, however, its effects on pain relief while patients are still in the ICU and when pain severity is highest remain unknown.
This study aims to compare the effect of three 20-minute hand massage administrations within 24 hours postop on the pain intensity (primary outcome), pain unpleasantness, pain interference, muscle tension, anxiety and vital signs (blood pressure, heart and respiratory rates) of adult intensive care unit (ICU) patients post cardiac surgery versus hand holding (i.e., simple touch) and standard care. Other objectives are to describe the location and quality of pain of cardiac surgery ICU patients.
Hypothesis:
Patients receiving 3 hand massages within 24 hours postop will have lower pain intensity, unpleasantness and interference, muscle tension, anxiety and vital signs compared to patients receiving hand holding and to those in the standard care group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •able to speak French or English
- •elective cardiac surgery requiring sternal incision (e.g., coronary artery bypass graft, valve replacement)
- •able to answer questions and self-report symptoms
排除标准
- •previous cardiac surgery
- •diagnostic of cognitive or psychiatric disorder
- •pulmonary artery pressure >50 mmHg
- •right ventricular failure
- •systolic left ventricular dysfunction (ejection fraction 35% or less)
- •body mass index > 30
- •prolonged bleeding from the chest drainage tubes (i.e., >200 ml/h)
- •having mechanical blood pressure support (e.g., intra-aortic balloon pump)
- •receiving cardiac pacing with complete control of HR
- •peripheral intravenous line in the hands
- •suppurating/infective/inflammatory skin condition of the hands
- •hypersensitivity to touch.
结局指标
主要结局
change in pain intensity from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale
时间窗: before and immediately after each intervention within 24 hours postoperatively
Pain intensity will be captured using the 0 to 10 Numeric Rating Scale score, and the analysis metric will be the change in pain intensity from baseline (pre-intervention) to immediately after each intervention. For each study group, means and standard deviations of patients' pain intensity levels will be reported. Change in pain intensity levels will be assessed for each of the three interventions administered within 24 hours postop.
次要结局
- changes in 1-minute blood pressure average from post-intervention to 30 minutes later as assessed using a data collection computer connected to patient's bedside monitor(immediately after each intervention and 30 minutes later within 24 hours postop)
- change in anxiety from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale(before and immediately after each intervention within 24 hours postop)
- change in pain unpleasantness from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)(immediately after each intervention and 30 minutes later within 24 hours postop)
- change in muscle tension from pre- to post-intervention by performing passive flexion and extension of patient's arm, and scoring 0 (relaxed), 1 (tense) or 2 (very tense/rigid)(before and immediately after each intervention within 24 hours postop)
- changes in 1-minute respiratory rate average from pre- to post-intervention as assessed using a data collection computer connected to patient's bedside monitor(before and immediately after each intervention within 24 hours postop)
- change in muscle tension from post-intervention to 30 minutes later by performing passive flexion and extension of patient's arm, and scoring 0 (relaxed), 1 (tense) or 2 (very tense/rigid)(immediately after each intervention and 30 minutes later within 24 hours postop)
- change in pain unpleasantness from pre- to post-intervention as assessed using the 0-10 Numeric Rating Scale(before and immediately after each intervention within 24 hours postop)
- changes in 1-minute blood pressure average from pre- to post-intervention as assessed using a data collection computer connected to patient's bedside monitor(before and immediately after each intervention within 24 hours postop)
- changes in 1-minute heart rate average from pre- to post-intervention as assessed using a data collection computer connected to patient's bedside monitor(before and immediately after each intervention within 24 hours postop)
- pain interference as assessed using the Brief Pain Inventory(on the second and fourth postoperative days)
- change in pain intensity from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)(immediately after each intervention and 30 minutes later within 24 hours postop)
- change in anxiety from post-intervention to 30 minutes later as assessed using the 0-10 Numeric Rating Scale (carry-over effect)(immediately after each intervention and 30 minutes later within 24 hours postop)
- changes in 1-minute heart rate average from post-intervention to 30 minutes later as assessed using a data collection computer connected to patient's bedside monitor(immediately after each intervention and 30 minutes later within 24 hours postop)
- changes in 1-minute respiratory rate average from post-intervention to 30 minutes later as assessed using a data collection computer connected to patient's bedside monitor(immediately after each intervention and 30 minutes later within 24 hours postop)
研究者
Céline Gélinas
Associate Professor
McGill University