Peter Hess® Sound Massage Versus Music Care® Relaxation for the Management of Anxiety and Pain in Patients Undergoing Coronary Artery Bypass Surgery in Thoracic and Cardiovascular Surgery: a Comparative Controlled and Randomised Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- State Trait Anxiety Inventory (STAI-A) score, between the 2 groups of patients
研究概览
简要总结
Cardiac surgery patients often undergo anxiousness and pain. Before surgery, anxiety is often caused by the idea of sternotomy, extracorporeal circulation, fear of post-operative pain, and even death. After surgery anxiety and pain can be the consequences of operative and peri-operative procedures. The investigators believe that reducing stress and pain by a relaxation therapy would lead to better stay in hospital and a better recovery after surgery.
Music Care® relaxation technique consists into listening to an audio relaxing soundtrack chosen by the patient. This technique has already proven with several clinical studies its efficiency for reducing pain and anxiety in hospital.
The research consists of comparing this technique to Peter Hess® sound massage for reducing pain and anxiety.
The Peter Hess® sound massage is a holistic relaxation technique that uses sound vibrations generated by therapeutic singing bowls.
Patients will be randomized in one of the two groups (Music Care® or Peter Hess®).
详细描述
- Cardiac surgery patients often undergo anxiousness and pain. Before surgery, anxiety is often caused by the idea of sternotomy, extracorporeal circulation, fear of post-operative pain, and even death. After surgery anxiety and pain can be the consequences of operative and peri-operative procedures. The investigators believe that reducing stress and pain by a relaxation therapy would lead to better stay in hospital and a better recovery after surgery.
- Design of the study: Controlled randomized single blind clinical trial / Interventional research protocol implying human being that doesn't involve any health product
- Patients will be randomized in one of the two following groups:
- Peter Hess® sound massage, a relaxation technic using singing bowls' sound vibrations The Peter Hess® sound massage is a holistic relaxation technique (body and mind) that uses sound vibrations generated by therapeutic singing bowls. Its efficiency and adaptability make it a complementary method that can be pertinent for many hospital departments, both for patients and caregivers.
- Music Care® relaxation technique, a validated Non-Medicinal Intervention which is a pyscho-musical relaxation technique using audio relaxation music diffused in dedicated headphone. The audio relaxing soundtracks are chosen by the patient. Music Care® technique has already proven with several clinical studies its efficiency for reducing pain and anxiety in hospital.
- Main Objective: Prove a better efficiency of the Peter Hess® sound massage for reducing anxiety compared to Music Care® relaxation technique.
- Main criteria: difference between the two groups on anxiety scores' variation (measured by STAI) between preoperative visit (J-1) and postoperative visit (J+7)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 40 and 70 years old
- •Hospitalized for a coronary bypass
- •That has given his written consent
- •Affiliated to a French social security system or entitled to a social security benefit.
排除标准
- •Emergency coronary bypass surgery
- •Impaired ventricular function (ejection fraction < 45%)
- •Combined surgery
- •Patient with chronic dialysis
- •Diagnosed with severe depression
- •Patient in a psychotic state
- •Patient with chronic pain
- •Patient incapable of giving his written consent
- •Patient deprived of liberty by judicial decision or benefiting from legal protection (under guardianship or curatorship)
- •Patient on AME
- •Participation in other interventional research involving humans, or being in the period of exclusion from previous research involving humans, if applicable.
- •Pregnant or breastfeeding woman
- •Patient with pacemaker
- •Patient with implanted metallic medical devices
- •Recently operated patient
- •Patient with hearing epilepsy
- •Tinnitus patient
结局指标
主要结局
State Trait Anxiety Inventory (STAI-A) score, between the 2 groups of patients
时间窗: At Day7 (after surgery)
Questionnaire based on a 4-point Likert scale and composed of 20 questions on a self-report basis. Higher scores are correlated with higher levels of anxiety.
次要结局
- Consumption of anxiolytic drugs(Through study completion, an average of 7 days)
- Consumption of antalgics(Through study completion, an average of 7 days)
- Sides effect(Through study completion, an average of 7 days)
- Demand of care in physiotherapy(Through study completion, an average of 7 days)
- Cardiac frequency(At Day-1 (day before surgery) and after surgery (at Day2 and Day4))
- State Trait Anxiety Inventory (STAI-A) score, in each group(At Day-1 (day before surgery) and after surgery (at Day2 and Day4))
- Pain assessment(At Day-1, Day2, Day3, Day4 and Day7.)
- Consumption of anti-inflammatory(Through study completion, an average of 7 days)
- Blood pressure(At Day-1 (day before surgery) and after surgery (at Day2 and Day4))
- Length of hospitalisation(At Day7 (end of participation))