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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
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

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

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    December 20, 2021
    Last Updated
    January 10, 2022
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    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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