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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02371-38 | Other Identifier | ANSM |
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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®).
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:
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peter Hess® sound massage | Experimental | Peter Hess® sound massage using bowls dedicated to this technique. |
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| Music relaxation Music Care® | Experimental | The patient chooses his music preferences and receive the music relaxation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peter Hess® sound massage | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Consumption of anxiolytic drugs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pascal LEPRINCE, PU-PH | Contact | 01 42 16 56 32 | +33 | pascal.leprince@aphp.fr |
| Raphaël CORNET, Music Therapist | Contact | 06 14 53 16 54 | +33 | raphaelcornetmusicotherapie@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pascal LEPRINCE, PU-PH | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| D002637 | Chest Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Music relaxation Music Care® | Other | The patient chooses his music preferences and receive the music relaxation in bed for 30 minutes. |
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| Questionnaires | Other |
|
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Drugs prescriptions will be reported |
| Through study completion, an average of 7 days |
| 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. |
| Consumption of antalgics | Drugs prescriptions will be reported | Through study completion, an average of 7 days |
| Consumption of anti-inflammatory | Drugs prescriptions will be reported | Through study completion, an average of 7 days |
| Demand of care in physiotherapy | Number of care in physiotherapy will be reported | Through study completion, an average of 7 days |
| 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) |
| 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) |
| Length of hospitalisation | Length of hospitalisation | At Day7 (end of participation) |
| Sides effect | Side effect reporting | Through study completion, an average of 7 days |
| D010335 | Pathologic Processes |
| D001523 | Mental Disorders |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |