Peter Hess® Sound Massage for Reducing Anxiety and Pain in Cardiac Surgery (MuSoCa)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Pain, Chest; Pain, Postoperative; Anxiety Postoperative; Anxiety; Pain; Thoracic Surgery

Treatments: Other: Music relaxation Music Care®; Other: Peter Hess® sound massage; Other: Questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT05204043

APHP190384

2020-A02371-38 (Other Identifier)

Details and patient eligibility

About

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®).

Full 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)

Enrollment: 80 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

Peter Hess® sound massage

Experimental group

Description:

Peter Hess® sound massage using bowls dedicated to this technique.

Treatment:

Other: Peter Hess® sound massage

Other: Questionnaires

Music relaxation Music Care®

Experimental group

Description:

The patient chooses his music preferences and receive the music relaxation.

Treatment:

Other: Music relaxation Music Care®

Other: Questionnaires