Peter Hess® Sound Massage for Reducing Anxiety and Pain in Cardiac Surgery (MuSoCa)
Primary Purpose
Pain, Pain, Postoperative, Pain, Chest
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Peter Hess® sound massage
Music relaxation Music Care®
Questionnaires
Sponsored by
About this trial
This is an interventional other trial for Pain focused on measuring Peter Hess, Music Care, Sound massage, sound therapy, music therapy, singing bowls, vibrations, relaxation, coronary bypass, cardiac surgery, cardiology, music
Eligibility Criteria
Inclusion Criteria:
- Patients between 40 and 70 years old
- Hospitalized for a coronary bypass
- That has given his written consent
- Affiliated to a French social security system or entitled to a social security benefit.
Exclusion Criteria:
- Emergency coronary bypass surgery
- Impaired ventricular function (ejection fraction < 45%)
- Combined surgery
- Patient with chronic dialysis
- Diagnosed with severe depression
- Patient in a psychotic state
- Patient with chronic pain
- Patient incapable of giving his written consent
- Patient deprived of liberty by judicial decision or benefiting from legal protection (under guardianship or curatorship)
- Patient on AME
- Participation in other interventional research involving humans, or being in the period of exclusion from previous research involving humans, if applicable.
- Pregnant or breastfeeding woman
- Patient with pacemaker
- Patient with implanted metallic medical devices
- Recently operated patient
- Patient with hearing epilepsy
- Tinnitus patient
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Peter Hess® sound massage
Music relaxation Music Care®
Arm Description
Peter Hess® sound massage using bowls dedicated to this technique.
The patient chooses his music preferences and receive the music relaxation.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Consumption of anxiolytic drugs
Drugs prescriptions will be reported
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
Consumption of antalgics
Drugs prescriptions will be reported
Consumption of anti-inflammatory
Drugs prescriptions will be reported
Demand of care in physiotherapy
Number of care in physiotherapy will be reported
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
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
Length of hospitalisation
Length of hospitalisation
Sides effect
Side effect reporting
Full Information
NCT ID
NCT05204043
First Posted
December 20, 2021
Last Updated
January 10, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT05204043
Brief Title
Peter Hess® Sound Massage for Reducing Anxiety and Pain in Cardiac Surgery
Acronym
MuSoCa
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Pain, Postoperative, Pain, Chest, Anxiety, Anxiety Postoperative, Thoracic Surgery
Keywords
Peter Hess, Music Care, Sound massage, sound therapy, music therapy, singing bowls, vibrations, relaxation, coronary bypass, cardiac surgery, cardiology, music
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Peter Hess® sound massage
Arm Type
Experimental
Arm Description
Peter Hess® sound massage using bowls dedicated to this technique.
Arm Title
Music relaxation Music Care®
Arm Type
Experimental
Arm Description
The patient chooses his music preferences and receive the music relaxation.
Intervention Type
Other
Intervention Name(s)
Peter Hess® sound massage
Intervention Description
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
Intervention Name(s)
Music relaxation Music Care®
Intervention Description
The patient chooses his music preferences and receive the music relaxation in bed for 30 minutes.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
State Trait Anxiety Inventory (STAI)
Pain assessment - Visual Analogic Scale (from 0 to 10).
Primary Outcome Measure Information:
Title
State Trait Anxiety Inventory (STAI-A) score, between the 2 groups of patients
Description
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.
Time Frame
At Day7 (after surgery)
Secondary Outcome Measure Information:
Title
State Trait Anxiety Inventory (STAI-A) score, in each group
Description
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.
Time Frame
At Day-1 (day before surgery) and after surgery (at Day2 and Day4)
Title
Consumption of anxiolytic drugs
Description
Drugs prescriptions will be reported
Time Frame
Through study completion, an average of 7 days
Title
Pain assessment
Description
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
Time Frame
At Day-1, Day2, Day3, Day4 and Day7.
Title
Consumption of antalgics
Description
Drugs prescriptions will be reported
Time Frame
Through study completion, an average of 7 days
Title
Consumption of anti-inflammatory
Description
Drugs prescriptions will be reported
Time Frame
Through study completion, an average of 7 days
Title
Demand of care in physiotherapy
Description
Number of care in physiotherapy will be reported
Time Frame
Through study completion, an average of 7 days
Title
Blood pressure
Description
Variation of blood pressure before and after Peter Hess sound massage or Music Care relaxation technique (depending of the arm) will be assessed
Time Frame
At Day-1 (day before surgery) and after surgery (at Day2 and Day4)
Title
Cardiac frequency
Description
Variation of cardiac frequency before and after Peter Hess sound massage or Music Care relaxation technique (depending of the arm) will be assessed
Time Frame
At Day-1 (day before surgery) and after surgery (at Day2 and Day4)
Title
Length of hospitalisation
Description
Length of hospitalisation
Time Frame
At Day7 (end of participation)
Title
Sides effect
Description
Side effect reporting
Time Frame
Through study completion, an average of 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients between 40 and 70 years old
Hospitalized for a coronary bypass
That has given his written consent
Affiliated to a French social security system or entitled to a social security benefit.
Exclusion Criteria:
Emergency coronary bypass surgery
Impaired ventricular function (ejection fraction < 45%)
Combined surgery
Patient with chronic dialysis
Diagnosed with severe depression
Patient in a psychotic state
Patient with chronic pain
Patient incapable of giving his written consent
Patient deprived of liberty by judicial decision or benefiting from legal protection (under guardianship or curatorship)
Patient on AME
Participation in other interventional research involving humans, or being in the period of exclusion from previous research involving humans, if applicable.
Pregnant or breastfeeding woman
Patient with pacemaker
Patient with implanted metallic medical devices
Recently operated patient
Patient with hearing epilepsy
Tinnitus patient
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pascal LEPRINCE, PU-PH
Phone
01 42 16 56 32
Ext
+33
Email
pascal.leprince@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Raphaël CORNET, Music Therapist
Phone
06 14 53 16 54
Ext
+33
Email
raphaelcornetmusicotherapie@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal LEPRINCE, PU-PH
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Peter Hess® Sound Massage for Reducing Anxiety and Pain in Cardiac Surgery
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