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

Peter Hess® Sound Massage Versus Music Care® Relaxation for the Management of Anxiety and Pain in Patients Undergoing Coronary Artery Bypass Surgery in Thoracic and Cardiovascular Surgery: a Comparative Controlled and Randomised Study.

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®).

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Pain, Postoperative; Anxiety; Thoracic Surgery; Pain, Chest; Anxiety Postoperative
• Intervention / Treatment: Other: Peter Hess® sound massage; Other: Questionnaires; Other: Music relaxation Music Care®

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pascal LEPRINCE, PU-PH; Phone Number: +33 01 42 16 56 32; Email: pascal.leprince@aphp.fr
• Study Contact Backup: Name: Raphaël CORNET, Music Therapist; Phone Number: +33 06 14 53 16 54; Email: raphaelcornetmusicotherapie@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Peter Hess® sound massage; Peter Hess® sound massage using bowls dedicated to this technique.	Other: 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.; Other: Questionnaires; State Trait Anxiety Inventory (STAI); Pain assessment - Visual Analogic Scale (from 0 to 10).
EXPERIMENTAL: Music relaxation Music Care®; The patient chooses his music preferences and receive the music relaxation.	Other: Questionnaires; State Trait Anxiety Inventory (STAI); Pain assessment - Visual Analogic Scale (from 0 to 10).; Other: Music relaxation Music Care®; The patient chooses his music preferences and receive the music relaxation in bed for 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Pascal LEPRINCE, PU-PH, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2022
• Primary Completion (ANTICIPATED): July 1, 2024
• Study Completion (ANTICIPATED): July 1, 2024

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (ACTUAL): January 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: cardiac surgery; music; music therapy; relaxation; cardiology; vibrations; coronary bypass; sound therapy; Peter Hess; Music Care; Sound massage; singing bowls
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Anxiety Disorders; Chest Pain
• Other Study ID Numbers: APHP190384; 2020-A02371-38 (OTHER: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No