Pain Clinical Trial
— MuSoCaOfficial title:
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.
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®).
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Patients between 40 and 70 years old 2. Hospitalized for a coronary bypass 3. That has given his written consent 4. Affiliated to a French social security system or entitled to a social security benefit. Exclusion Criteria: 1. Emergency coronary bypass surgery 2. Impaired ventricular function (ejection fraction < 45%) 3. Combined surgery 4. Patient with chronic dialysis 5. Diagnosed with severe depression 6. Patient in a psychotic state 7. Patient with chronic pain 8. Patient incapable of giving his written consent 9. Patient deprived of liberty by judicial decision or benefiting from legal protection (under guardianship or curatorship) 10. Patient on AME 11. Participation in other interventional research involving humans, or being in the period of exclusion from previous research involving humans, if applicable. 12. Pregnant or breastfeeding woman 13. Patient with pacemaker 14. Patient with implanted metallic medical devices 15. Recently operated patient 16. Patient with hearing epilepsy 17. Tinnitus patient |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assistance Publique - Hôpitaux de Paris |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | State Trait Anxiety Inventory (STAI-A) score, between the 2 groups of patients | 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. |
At Day7 (after surgery) | |
Secondary | State Trait Anxiety Inventory (STAI-A) score, in each group | 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. |
At Day-1 (day before surgery) and after surgery (at Day2 and Day4) | |
Secondary | Consumption of anxiolytic drugs | Drugs prescriptions will be reported | Through study completion, an average of 7 days | |
Secondary | Pain assessment | Visual Analogic Scale (score from 0 to 10). Higher scores are correlated with higher levels of pain.
VAS filled twice at Day-1, Day2 and Day4 (before and after the intervention (Peter Hess sound massage / Music Care)) VAS filled once at Day3 and Day7 |
At Day-1, Day2, Day3, Day4 and Day7. | |
Secondary | Consumption of antalgics | Drugs prescriptions will be reported | Through study completion, an average of 7 days | |
Secondary | Consumption of anti-inflammatory | Drugs prescriptions will be reported | Through study completion, an average of 7 days | |
Secondary | Demand of care in physiotherapy | Number of care in physiotherapy will be reported | Through study completion, an average of 7 days | |
Secondary | Blood pressure | Variation of blood pressure before and after Peter Hess sound massage or Music Care relaxation technique (depending of the arm) will be assessed | At Day-1 (day before surgery) and after surgery (at Day2 and Day4) | |
Secondary | Cardiac frequency | Variation of cardiac frequency before and after Peter Hess sound massage or Music Care relaxation technique (depending of the arm) will be assessed | At Day-1 (day before surgery) and after surgery (at Day2 and Day4) | |
Secondary | Length of hospitalisation | Length of hospitalisation | At Day7 (end of participation) | |
Secondary | Sides effect | Side effect reporting | Through study completion, an average of 7 days |
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