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

Not Applicable

• Conditions: Pain; Pain, Chest; Anxiety; Thoracic Surgery; Anxiety Postoperative; Pain, Postoperative
• Interventions: Other: Peter Hess® sound massage; Other: Music relaxation Music Care®; Other: Questionnaires

• Registration Number: NCT05204043
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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)

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-20
• Study Start: 2022-01
• Study First Submitted QC: 2022-01-10
• Last Update Submitted: 2022-01-10
• Study First Posted: 2022-01-24
• Last Update Posted: 2022-01-24
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peter Hess® sound massage	Questionnaires	Peter Hess® sound massage using bowls dedicated to this technique.
Music relaxation Music Care®	Questionnaires	The patient chooses his music preferences and receive the music relaxation.
Peter Hess® sound massage	Peter Hess® sound massage	Peter Hess® sound massage using bowls dedicated to this technique.
Music relaxation Music Care®	Music relaxation Music Care®	The patient chooses his music preferences and receive the music relaxation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Length of hospitalisation	At Day7 (end of participation)	Length of hospitalisation
Consumption of anxiolytic drugs	Through study completion, an average of 7 days	Drugs prescriptions will be reported
Consumption of antalgics	Through study completion, an average of 7 days	Drugs prescriptions will be reported
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
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
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.
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 anti-inflammatory	Through study completion, an average of 7 days	Drugs prescriptions will be reported
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