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

NCT05204043 | Unknown

• 2 other identifiers: APHP1903842020-A02371-38
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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®).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• State Trait Anxiety Inventory (STAI-A) score, in each group

  At Day-1 (day before surgery) and after surgery (at Day2 and Day4)

• Consumption of anxiolytic drugs

  Through study completion, an average of 7 days

• Pain assessment

  At Day-1, Day2, Day3, Day4 and Day7.

• Consumption of antalgics

  Through study completion, an average of 7 days

• Consumption of anti-inflammatory

  Through study completion, an average of 7 days

Study Arms (2)

Peter Hess® sound massage

EXPERIMENTAL

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

Other: Peter Hess® sound massage; Other: Questionnaires

Music relaxation Music Care®

EXPERIMENTAL

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

Other: Music relaxation Music Care®; Other: Questionnaires

Interventions

Peter Hess® sound massage 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.

Peter Hess® sound massage

Music relaxation Music Care® OTHER

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

Music relaxation Music Care®

Questionnaires OTHER

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

Music relaxation Music Care®; Peter Hess® sound massage

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Pregnant or breastfeeding woman
• Patient with pacemaker
• Patient with implanted metallic medical devices
• Recently operated patient
• Patient with hearing epilepsy

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Pain; Pain, Postoperative; Chest Pain; Anxiety Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Pascal LEPRINCE, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal LEPRINCE, PU-PH

CONTACT

01 42 16 56 32; pascal.leprince@aphp.fr

Raphaël CORNET, Music Therapist

CONTACT

06 14 53 16 54; raphaelcornetmusicotherapie@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 24, 2022
• Study Start: January 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: January 24, 2022

Record last verified: 2021-12