Anxiety, Anxiety Postoperative, Pain, Pain, Chest, Pain, Postoperative, Thoracic Surgery
Conditions
Keywords
Peter Hess, Music Care, Sound massage, sound therapy, music therapy, singing bowls, vibrations, relaxation, coronary bypass, cardiac surgery, cardiology, music
Brief summary
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®).
Detailed description
* 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: 1. 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. 2. 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)
Interventions
OTHERPeter Hess® sound massage
The Peter Hess® sound massage uses sound vibrations generated by therapeutic singing bowls. Peter Hess' methods act far from a traumatised area, far from the pain. It will be given on the patient's bed for 30 minutes.
OTHERMusic relaxation Music Care®
The patient chooses his music preferences and receive the music relaxation in bed for 30 minutes.
OTHERQuestionnaires
* State Trait Anxiety Inventory (STAI) * Pain assessment - Visual Analogic Scale (from 0 to 10).
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| State Trait Anxiety Inventory (STAI-A) score, between the 2 groups of patients | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consumption of anxiolytic drugs | Through study completion, an average of 7 days | Drugs prescriptions will be reported |
| Pain assessment | At Day-1, Day2, Day3, Day4 and Day7. | 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 |
| Consumption of antalgics | Through study completion, an average of 7 days | Drugs prescriptions will be reported |
| Consumption of anti-inflammatory | Through study completion, an average of 7 days | Drugs prescriptions will be reported |
| State Trait Anxiety Inventory (STAI-A) score, in each group | At Day-1 (day before surgery) and after surgery (at Day2 and Day4) | 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. |
| Blood pressure | At Day-1 (day before surgery) and after surgery (at Day2 and Day4) | Variation of blood pressure before and after Peter Hess sound massage or Music Care relaxation technique (depending of the arm) will be assessed |
| Cardiac frequency | At Day-1 (day before surgery) and after surgery (at Day2 and Day4) | Variation of cardiac frequency before and after Peter Hess sound massage or Music Care relaxation technique (depending of the arm) will be assessed |
| Length of hospitalisation | At Day7 (end of participation) | Length of hospitalisation |
| Sides effect | Through study completion, an average of 7 days | Side effect reporting |
| Demand of care in physiotherapy | Through study completion, an average of 7 days | Number of care in physiotherapy will be reported |
Contacts
Primary ContactPascal LEPRINCE, PU-PH
Backup ContactRaphaël CORNET, Music Therapist
Outcome results
None listed