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

NCT ID: NCT05204043

Last Updated: 2022-01-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2024-07-31

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)

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Peter Hess® sound massage

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

Group Type: EXPERIMENTAL

Peter Hess® sound massage

Intervention Type: 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.

Questionnaires

Intervention Type: OTHER

• State Trait Anxiety Inventory (STAI)
• Pain assessment - Visual Analogic Scale (from 0 to 10).

Music relaxation Music Care®

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

Group Type: EXPERIMENTAL

Music relaxation Music Care®

Intervention Type: OTHER

The patient chooses his music preferences and receive the music relaxation in bed for 30 minutes.

Questionnaires

Intervention Type: OTHER

• State Trait Anxiety Inventory (STAI)
• Pain assessment - Visual Analogic Scale (from 0 to 10).

Interventions

Peter 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.

Intervention Type: OTHER

Music relaxation Music Care®

The patient chooses his music preferences and receive the music relaxation in bed for 30 minutes.

Intervention Type: OTHER

Questionnaires

• State Trait Anxiety Inventory (STAI)
• Pain assessment - Visual Analogic Scale (from 0 to 10).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal LEPRINCE, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Central Contacts

Pascal LEPRINCE, PU-PH

Role: CONTACT

pascal.leprince@aphp.fr

01 42 16 56 32 ext. +33

Raphaël CORNET, Music Therapist

Role: CONTACT

raphaelcornetmusicotherapie@gmail.com

06 14 53 16 54 ext. +33

Other Identifiers

2020-A02371-38

Identifier Type: OTHER

Identifier Source: secondary_id

APHP190384

Identifier Type: -

Identifier Source: org_study_id